Trial Outcomes & Findings for Behavioral Weight Loss and Stigma Reduction (NCT NCT03704064)
NCT ID: NCT03704064
Last Updated: 2022-11-02
Results Overview
Estimated mean percent change in weight from baseline to week 72
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
105 participants
Primary outcome timeframe
Baseline to week 72
Results posted on
2022-11-02
Participant Flow
Participant milestones
| Measure |
Stigma + BWL Intervention
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
53
|
|
Overall Study
Week 20
|
44
|
46
|
|
Overall Study
Week 46
|
44
|
46
|
|
Overall Study
Week 72
|
42
|
47
|
|
Overall Study
COMPLETED
|
42
|
47
|
|
Overall Study
NOT COMPLETED
|
10
|
6
|
Reasons for withdrawal
| Measure |
Stigma + BWL Intervention
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
No longer available for study visits
|
0
|
1
|
|
Overall Study
Censoring event
|
1
|
0
|
Baseline Characteristics
Behavioral Weight Loss and Stigma Reduction
Baseline characteristics by cohort
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.96 years
STANDARD_DEVIATION 12.86 • n=99 Participants
|
49.15 years
STANDARD_DEVIATION 12.05 • n=107 Participants
|
49.06 years
STANDARD_DEVIATION 12.40 • n=206 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Weight
|
104.39 kg
STANDARD_DEVIATION 18.21 • n=99 Participants
|
104.48 kg
STANDARD_DEVIATION 21.04 • n=107 Participants
|
104.44 kg
STANDARD_DEVIATION 19.59 • n=206 Participants
|
|
Height
|
165.04 cm
STANDARD_DEVIATION 7.13 • n=99 Participants
|
166.35 cm
STANDARD_DEVIATION 7.87 • n=107 Participants
|
165.70 cm
STANDARD_DEVIATION 7.51 • n=206 Participants
|
|
Body mass index (BMI)
|
38.23 kg/m^2
STANDARD_DEVIATION 5.59 • n=99 Participants
|
37.48 kg/m^2
STANDARD_DEVIATION 5.16 • n=107 Participants
|
37.85 kg/m^2
STANDARD_DEVIATION 5.36 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 72Estimated mean percent change in weight from baseline to week 72
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Percent Weight Change at Week 72
|
-7.16 percent weight change
Standard Error 0.95
|
-5.19 percent weight change
Standard Error 0.92
|
SECONDARY outcome
Timeframe: Baseline to week 72The percentage of participants who lost 5% or greater of their initial body weight at week 72
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Loss of 5% or Greater of Initial Body Weight at Week 72
|
20 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Baseline to week 72The percentage of participants who lost 10% or greater of their initial body weight at week 72
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Loss of 10% or Greater of Initial Body Weight at Week 72
|
14 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline to week 46Estimated mean percent weight change
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Percent Weight Change at Week 46
|
-8.2 percent weight change
Standard Error 0.9
|
-5.9 percent weight change
Standard Error 0.9
|
SECONDARY outcome
Timeframe: Baseline to week 20Estimated mean percent weight change
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Percent Weight Change at Week 20
|
-6.7 percent weight change
Standard Error 0.9
|
-5.7 percent weight change
Standard Error 0.9
|
SECONDARY outcome
Timeframe: Baseline to week 46The percentage of participants who lost 5% or greater of their initial body weight at week 46
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Loss of 5% or Greater of Initial Body Weight at Week 46
|
28 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Baseline to week 46The percentage of participants who lost 10% or greater of their initial body weight at week 46
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Loss of 10% or Greater of Initial Body Weight at Week 46
|
15 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline to week 20The percentage of participants who lost 5% or greater of their initial body weight at week 20
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Loss of 5% or Greater of Initial Body Weight at Week 20
|
31 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Baseline to week 20The percentage of participants who lost 10% or greater of their initial body weight at week 20
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Loss of 10% or Greater of Initial Body Weight at Week 20
|
11 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline to week 72Estimated mean change in daily minutes of physical activity, as measured by accelerometry
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Change in Minutes of Physical Activity (Accelerometer) at Week 72
MVPA per day with 10 minute bouts
|
9.6 Minutes per day
Standard Error 4.1
|
7.2 Minutes per day
Standard Error 4.1
|
|
Change in Minutes of Physical Activity (Accelerometer) at Week 72
MVPA per day with 20 minute bouts
|
9.4 Minutes per day
Standard Error 3.2
|
8.4 Minutes per day
Standard Error 3.1
|
|
Change in Minutes of Physical Activity (Accelerometer) at Week 72
Moderate activity per day
|
3.2 Minutes per day
Standard Error 6.8
|
-10.2 Minutes per day
Standard Error 6.7
|
|
Change in Minutes of Physical Activity (Accelerometer) at Week 72
Light activity per day
|
-35.6 Minutes per day
Standard Error 15.1
|
-51.5 Minutes per day
Standard Error 14.3
|
SECONDARY outcome
Timeframe: Baseline to week 46Estimated mean change in daily minutes of physical activity, as measured by accelerometry
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Change in Minutes of Physical Activity (Accelerometer) at Week 46
MVPA per day with 10 minute bouts
|
9.5 Minutes per day
Standard Error 4.3
|
5.4 Minutes per day
Standard Error 4.4
|
|
Change in Minutes of Physical Activity (Accelerometer) at Week 46
MVPA per day with 20 minute bouts
|
9.9 Minutes per day
Standard Error 3.4
|
10.5 Minutes per day
Standard Error 3.2
|
|
Change in Minutes of Physical Activity (Accelerometer) at Week 46
Moderate activity per day
|
0.6 Minutes per day
Standard Error 7.2
|
-17.9 Minutes per day
Standard Error 7.2
|
|
Change in Minutes of Physical Activity (Accelerometer) at Week 46
Light activity per day
|
-37.1 Minutes per day
Standard Error 15.9
|
-67.0 Minutes per day
Standard Error 16.0
|
SECONDARY outcome
Timeframe: Baseline to week 20Estimated mean change in daily minutes of physical activity, as measured by accelerometry
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Change in Minutes of Physical Activity (Accelerometer) at Week 20
MVPA per day with 10 minute bouts
|
11.4 Minutes per day
Standard Error 4.0
|
8.8 Minutes per day
Standard Error 4.1
|
|
Change in Minutes of Physical Activity (Accelerometer) at Week 20
MVPA per day with 20 minute bouts
|
10.5 Minutes per day
Standard Error 2.6
|
9.9 Minutes per day
Standard Error 2.7
|
|
Change in Minutes of Physical Activity (Accelerometer) at Week 20
Moderate activity per day
|
10.6 Minutes per day
Standard Error 6.7
|
4.7 Minutes per day
Standard Error 6.7
|
|
Change in Minutes of Physical Activity (Accelerometer) at Week 20
Light activity per day
|
-19.0 Minutes per day
Standard Error 14.2
|
3.8 Minutes per day
Standard Error 13.2
|
SECONDARY outcome
Timeframe: Baseline to week 72Estimated mean change in energy expenditure, as measured by the Paffenbarger Physical Activity Questionnaire. Higher kilocalories (kcal) indicate greater energy expenditure.
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Change in Energy Expenditure at Week 72
|
314.8 Kcal
Standard Error 105.9
|
307.5 Kcal
Standard Error 108.0
|
SECONDARY outcome
Timeframe: Baseline to week 46Estimated mean change in energy expenditure, as measured by the Paffenbarger Physical Activity Questionnaire. Higher kilocalories (kcal) indicate greater energy expenditure.
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Change in Energy Expenditure at Week 46
|
148.7 Kcal
Standard Error 90.1
|
260.4 Kcal
Standard Error 103.5
|
SECONDARY outcome
Timeframe: Baseline to week 20Estimated mean change in energy expenditure, as measured by the Paffenbarger Physical Activity Questionnaire. Higher kilocalories (kcal) indicate greater energy expenditure.
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Change in Energy Expenditure at Week 20
|
452.5 Kcal
Standard Error 111.9
|
289.3 Kcal
Standard Error 105.6
|
SECONDARY outcome
Timeframe: Baseline to week 72Estimated mean change on the Self-Efficacy to Exercise Scale (total score 0-90; higher scores = greater self-efficacy)
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Change in Exercise Self-efficacy at Week 72
|
-9.4 score on a scale
Standard Error 3.3
|
-15.0 score on a scale
Standard Error 3.2
|
SECONDARY outcome
Timeframe: Baseline to week 46Estimated mean change on the Self-Efficacy to Exercise Scale (total score 0-90; higher scores = greater self-efficacy)
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Change in Exercise Self-efficacy at Week 46
|
-10.6 score on a scale
Standard Error 3.2
|
-15.9 score on a scale
Standard Error 3.2
|
SECONDARY outcome
Timeframe: Baseline to week 20Estimated mean change on the Self-Efficacy to Exercise Scale (total score 0-90; higher scores = greater self-efficacy)
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Change in Exercise Self-efficacy at Week 20
|
1.1 score on a scale
Standard Error 3.2
|
-2.0 score on a scale
Standard Error 3.1
|
SECONDARY outcome
Timeframe: Baseline to week 72Estimated mean change on the Weight Efficacy Lifestyle Questionnaire - Short Form (total score 0-72; higher scores = greater self-efficacy)
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Change in Eating Self-efficacy at Week 72
|
6.5 score on a scale
Standard Error 2.5
|
1.7 score on a scale
Standard Error 2.4
|
SECONDARY outcome
Timeframe: Baseline to week 46Estimated mean change on the Weight Efficacy Lifestyle Questionnaire - Short Form (total score 0-72; higher scores = greater self-efficacy)
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Change in Eating Self-efficacy at Week 46
|
5.8 score on a scale
Standard Error 2.4
|
-1.0 score on a scale
Standard Error 2.4
|
SECONDARY outcome
Timeframe: Baseline to week 20Estimated mean change on the Weight Efficacy Lifestyle Questionnaire - Short Form (total score 0-72; higher scores = greater self-efficacy)
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Change in Eating Self-efficacy at Week 20
|
12.3 score on a scale
Standard Error 2.4
|
8.6 score on a scale
Standard Error 2.3
|
SECONDARY outcome
Timeframe: Baseline to week 72Estimated mean change in triglyceride concentration in blood
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Change in Triglycerides at Week 72
|
-9.9 mg/dL
Standard Error 6.4
|
-13.7 mg/dL
Standard Error 6.8
|
SECONDARY outcome
Timeframe: Baseline to week 20Estimated mean change in triglyceride concentration in blood
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Change in Triglycerides at Week 20
|
-10.9 mg/dL
Standard Error 6.3
|
-7.7 mg/dL
Standard Error 6.5
|
SECONDARY outcome
Timeframe: Baseline to week 72Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg)
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Change in Blood Pressure at Week 72
Systolic Blood Pressure
|
-5.0 mmHg
Standard Error 1.7
|
-5.6 mmHg
Standard Error 1.8
|
|
Change in Blood Pressure at Week 72
Diastolic Blood Pressure
|
-1.9 mmHg
Standard Error 1.1
|
-2.0 mmHg
Standard Error 1.1
|
SECONDARY outcome
Timeframe: Baseline to week 20Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg)
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Change in Blood Pressure Week 20
Systolic Blood Pressure
|
-9.7 mmHG
Standard Error 1.7
|
-5.4 mmHG
Standard Error 1.6
|
|
Change in Blood Pressure Week 20
Diastolic Blood Pressure
|
-3.5 mmHG
Standard Error 1.1
|
-3.6 mmHG
Standard Error 1.1
|
SECONDARY outcome
Timeframe: Baseline to week 72Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization).
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Change in Weight Bias Internalization Scale Score at Week 72
|
-1.7 score on a scale
Standard Error 0.2
|
-1.5 score on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline to week 46Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Change in Weight Bias Internalization Scale Score at Week 46
|
-1.5 score on a scale
Standard Error 0.1
|
-1.4 score on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline to week 20Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Change in Weight Bias Internalization Scale Score at Week 20
|
-1.4 score on a scale
Standard Error 0.1
|
-1.2 score on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Baseline to week 72Percentage of participants who score below 4.0 on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
"Remission" of Elevated Weight Bias Internalization at Week 72
|
28 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Baseline to week 46Percentage of participants who score below 4.0 on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
"Remission" of Elevated Weight Bias Internalization at Week 46
|
24 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Baseline to week 20Percentage of participants who score below 4.0 on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
"Remission" of Elevated Weight Bias Internalization at Week 20
|
25 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Baseline to week 72Estimated mean change score for Total score (WSSQ-Total, summed 12-60) and two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FE) (summed 6-30); higher scores indicate greater weight self-stigma.
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Change in Weight Self-stigma Scores at Week 72
WSSQ-Total
|
-9.7 score on a scale
Standard Error 1.1
|
-6.7 score on a scale
Standard Error 1.1
|
|
Change in Weight Self-stigma Scores at Week 72
WSSQ-SD
|
-5.0 score on a scale
Standard Error 0.7
|
-3.8 score on a scale
Standard Error 0.6
|
|
Change in Weight Self-stigma Scores at Week 72
WSSQ-FE
|
-4.7 score on a scale
Standard Error 0.7
|
-2.9 score on a scale
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Baseline to week 46Estimated mean change score for Total score (WSSQ-Total, summed 12-60) and two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FE) (summed 6-30); higher scores indicate greater weight self-stigma.
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Change in Weight Self-stigma Scores at Week 46
WSSQ-Total
|
-8.5 score on a scale
Standard Error 1.1
|
-5.5 score on a scale
Standard Error 1.1
|
|
Change in Weight Self-stigma Scores at Week 46
WSSQ-SD
|
-4.0 score on a scale
Standard Error 0.7
|
-2.8 score on a scale
Standard Error 0.6
|
|
Change in Weight Self-stigma Scores at Week 46
WSSQ-FE
|
-4.5 score on a scale
Standard Error 0.6
|
-2.7 score on a scale
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Baseline to week 20Estimated mean change score for Total score (WSSQ-Total, summed 12-60) and two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FE) (summed 6-30); higher scores indicate greater weight self-stigma.
Outcome measures
| Measure |
Stigma + BWL Intervention
n=52 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Change in Weight Self-stigma Scores at Week 20
WSSQ-FE
|
-3.6 score on a scale
Standard Error 0.6
|
-2.3 score on a scale
Standard Error 0.6
|
|
Change in Weight Self-stigma Scores at Week 20
WSSQ-Total
|
-8.2 score on a scale
Standard Error 1.1
|
-5.5 score on a scale
Standard Error 1.1
|
|
Change in Weight Self-stigma Scores at Week 20
WSSQ-SD
|
-4.6 score on a scale
Standard Error 0.7
|
-3.2 score on a scale
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Week 20Population: Participants randomized to the stigma + BWL group did not receive (and thus did not rate) the recipe exchange component of treatment. Participants in the Standard BWL group did not receive (and did not rate) the BIAS treatment component.
To assess treatment acceptability, participants in both groups rated (1-7) how acceptable and helpful the program was, how much they liked the program, and how satisfied they were; scores for these 4 items were averaged. Participants also rated (1-7) the BWL treatment, as well as the stigma intervention (i.e., BIAS component) or recipe exchange, on how helpful they found each component of the program, how much they liked the components, and how much they learned. Scores for these three items were averaged (1-7) separately for the BWL treatment, BIAS component, and recipe exchange. Participants rated how much they learned BWL scores, and how much they learned and used skills related to stigma (all averaged 1-7). Higher scores indicate greater treatment acceptability.
Outcome measures
| Measure |
Stigma + BWL Intervention
n=44 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=48 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Treatment Acceptability at Week 20
Overall treatment acceptability
|
6.4 score on a scale
Standard Error 0.2
|
5.8 score on a scale
Standard Error 0.2
|
|
Treatment Acceptability at Week 20
BWL component acceptability
|
6.1 score on a scale
Standard Error 0.2
|
5.9 score on a scale
Standard Error 0.2
|
|
Treatment Acceptability at Week 20
BIAS vs recipe component acceptability
|
6.1 score on a scale
Standard Error 0.2
|
4.6 score on a scale
Standard Error 0.2
|
|
Treatment Acceptability at Week 20
BWL skill acquisition
|
6.2 score on a scale
Standard Error 0.2
|
5.6 score on a scale
Standard Error 0.2
|
|
Treatment Acceptability at Week 20
Stigma-related skill acquisition
|
5.8 score on a scale
Standard Error 0.2
|
4.9 score on a scale
Standard Error 0.2
|
|
Treatment Acceptability at Week 20
Stigma-related skill use
|
4.1 score on a scale
Standard Error 0.1
|
3.3 score on a scale
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Week 72Population: Participants randomized to the stigma + BWL group did not receive (and thus did not rate) the recipe exchange component of treatment. Participants in the Standard BWL group did not receive (and did not rate) the BIAS treatment component.
To assess treatment acceptability, participants in both groups rated (1-7) how acceptable and helpful the program was, how much they liked the program, and how satisfied they were; scores for these 4 items were averaged. Participants also rated (1-7) the BWL treatment, as well as the stigma intervention (i.e., BIAS component) or recipe exchange, on how helpful they found each component of the program, how much they liked the components, and how much they learned. Scores for these three items were averaged (1-7) separately for the BWL treatment, BIAS component, and recipe exchange. Participants rated how much they learned BWL scores, and how much they learned and used skills related to stigma (all averaged 1-7). Higher scores indicate greater treatment acceptability.
Outcome measures
| Measure |
Stigma + BWL Intervention
n=41 Participants
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=44 Participants
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Treatment Acceptability at Week 72
Overall treatment acceptability
|
6.1 score on a scale
Standard Error 0.2
|
5.8 score on a scale
Standard Error 0.2
|
|
Treatment Acceptability at Week 72
BWL component acceptability
|
6.0 score on a scale
Standard Error 0.2
|
5.7 score on a scale
Standard Error 0.2
|
|
Treatment Acceptability at Week 72
BIAS vs recipe component acceptability
|
5.9 score on a scale
Standard Error 0.3
|
4.1 score on a scale
Standard Error 0.3
|
|
Treatment Acceptability at Week 72
BWL skill acquisition
|
5.9 score on a scale
Standard Error 0.2
|
5.6 score on a scale
Standard Error 0.2
|
|
Treatment Acceptability at Week 72
Stigma-related skill acquisition
|
5.8 score on a scale
Standard Error 0.2
|
5.0 score on a scale
Standard Error 0.2
|
|
Treatment Acceptability at Week 72
Stigma-related skill use
|
3.8 score on a scale
Standard Error 0.1
|
3.3 score on a scale
Standard Error 0.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 72Single item from Global Physical Activity Questionnaire (minutes)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 46Single item from Global Physical Activity Questionnaire (minutes)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 20Single item from Global Physical Activity Questionnaire (minutes)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 72Concentration in blood, controlling for medication use
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 20Concentration in blood, controlling for medication use
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 72Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 20Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 72Concentration in blood, controlling for medication use
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 20Concentration in blood, controlling for medication use
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 72Concentration in blood
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 20Concentration in blood
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 72Fat Phobia Scale (scores averaged 1-5, with higher scores indicating greater weight bias)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 46Fat Phobia Scale (scores averaged 1-5, with higher scores indicating greater weight bias)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 20Fat Phobia Scale (scores averaged 1-5, with higher scores indicating greater weight bias)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 72Impact of Weight on Quality of Life Questionnaire-Lite (total score and 5 subscales; t-scores ranging from 0-100, with higher scores indicating better quality of life)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 46Impact of Weight on Quality of Life Questionnaire-Lite (total score and 5 subscales; t-scores ranging from 0-100, with higher scores indicating better quality of life)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 20Impact of Weight on Quality of Life Questionnaire-Lite (total score and 5 subscales; t-scores ranging from 0-100, with higher scores indicating better quality of life)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 72Perceived Stress Scale (total score 0-40; higher scores = greater perceived stress)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 46Perceived Stress Scale (total score 0-40; higher scores = greater perceived stress)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 20Perceived Stress Scale (total score 0-40; higher scores = greater perceived stress)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 72Patient Health Questionnaire-9 (scores summed 0-27; higher scores = more symptoms of depression)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 46Patient Health Questionnaire-9 (scores summed 0-27; higher scores = more symptoms of depression)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 20Patient Health Questionnaire-9 (scores summed 0-27; higher scores = more symptoms of depression)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 72Body Appreciation Scale (scores averaged 1-5; higher scores = greater body appreciation)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 46Body Appreciation Scale (scores averaged 1-5; higher scores = greater body appreciation)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 20Body Appreciation Scale (scores averaged 1-5; higher scores = greater body appreciation)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 72Questionnaire on Eating and Weight Patterns (yes/no and episodes per week)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 46Questionnaire on Eating and Weight Patterns (yes/no and episodes per week)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 20Questionnaire on Eating and Weight Patterns (yes/no and episodes per week)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 72Food records and self-report recording of food intake and physical activity
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 46Food records and self-report recording of food intake and physical activity
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to week 20Food records and self-report recording of food intake and physical activity
Outcome measures
Outcome data not reported
Adverse Events
Stigma + BWL Intervention
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Standard BWL Intervention
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Stigma + BWL Intervention
n=52 participants at risk
Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity.
|
Standard BWL Intervention
n=53 participants at risk
Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.8%
3/52 • Number of events 3 • Baseline through week 72
At each contact with participants, study personnel non-systematically collected information on any adverse events (AEs) self-reported by participants. In addition, AEs were systematically assessed at the scheduled assessments. AEs were documented by study staff in consultation with a nurse practitioner and/or physician. Serious adverse events (SAEs) were reported immediately to the study sponsor, Data and Safety Monitor, and the Institutional Review Board.
|
9.4%
5/53 • Number of events 6 • Baseline through week 72
At each contact with participants, study personnel non-systematically collected information on any adverse events (AEs) self-reported by participants. In addition, AEs were systematically assessed at the scheduled assessments. AEs were documented by study staff in consultation with a nurse practitioner and/or physician. Serious adverse events (SAEs) were reported immediately to the study sponsor, Data and Safety Monitor, and the Institutional Review Board.
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
5.8%
3/52 • Number of events 3 • Baseline through week 72
At each contact with participants, study personnel non-systematically collected information on any adverse events (AEs) self-reported by participants. In addition, AEs were systematically assessed at the scheduled assessments. AEs were documented by study staff in consultation with a nurse practitioner and/or physician. Serious adverse events (SAEs) were reported immediately to the study sponsor, Data and Safety Monitor, and the Institutional Review Board.
|
7.5%
4/53 • Number of events 5 • Baseline through week 72
At each contact with participants, study personnel non-systematically collected information on any adverse events (AEs) self-reported by participants. In addition, AEs were systematically assessed at the scheduled assessments. AEs were documented by study staff in consultation with a nurse practitioner and/or physician. Serious adverse events (SAEs) were reported immediately to the study sponsor, Data and Safety Monitor, and the Institutional Review Board.
|
|
Product Issues
Contact dermatitis
|
7.7%
4/52 • Number of events 4 • Baseline through week 72
At each contact with participants, study personnel non-systematically collected information on any adverse events (AEs) self-reported by participants. In addition, AEs were systematically assessed at the scheduled assessments. AEs were documented by study staff in consultation with a nurse practitioner and/or physician. Serious adverse events (SAEs) were reported immediately to the study sponsor, Data and Safety Monitor, and the Institutional Review Board.
|
3.8%
2/53 • Number of events 2 • Baseline through week 72
At each contact with participants, study personnel non-systematically collected information on any adverse events (AEs) self-reported by participants. In addition, AEs were systematically assessed at the scheduled assessments. AEs were documented by study staff in consultation with a nurse practitioner and/or physician. Serious adverse events (SAEs) were reported immediately to the study sponsor, Data and Safety Monitor, and the Institutional Review Board.
|
|
Infections and infestations
COVID-19
|
3.8%
2/52 • Number of events 2 • Baseline through week 72
At each contact with participants, study personnel non-systematically collected information on any adverse events (AEs) self-reported by participants. In addition, AEs were systematically assessed at the scheduled assessments. AEs were documented by study staff in consultation with a nurse practitioner and/or physician. Serious adverse events (SAEs) were reported immediately to the study sponsor, Data and Safety Monitor, and the Institutional Review Board.
|
5.7%
3/53 • Number of events 3 • Baseline through week 72
At each contact with participants, study personnel non-systematically collected information on any adverse events (AEs) self-reported by participants. In addition, AEs were systematically assessed at the scheduled assessments. AEs were documented by study staff in consultation with a nurse practitioner and/or physician. Serious adverse events (SAEs) were reported immediately to the study sponsor, Data and Safety Monitor, and the Institutional Review Board.
|
|
Infections and infestations
Viral gastroenteritis
|
5.8%
3/52 • Number of events 3 • Baseline through week 72
At each contact with participants, study personnel non-systematically collected information on any adverse events (AEs) self-reported by participants. In addition, AEs were systematically assessed at the scheduled assessments. AEs were documented by study staff in consultation with a nurse practitioner and/or physician. Serious adverse events (SAEs) were reported immediately to the study sponsor, Data and Safety Monitor, and the Institutional Review Board.
|
13.2%
7/53 • Number of events 7 • Baseline through week 72
At each contact with participants, study personnel non-systematically collected information on any adverse events (AEs) self-reported by participants. In addition, AEs were systematically assessed at the scheduled assessments. AEs were documented by study staff in consultation with a nurse practitioner and/or physician. Serious adverse events (SAEs) were reported immediately to the study sponsor, Data and Safety Monitor, and the Institutional Review Board.
|
|
Nervous system disorders
Migraine
|
7.7%
4/52 • Number of events 4 • Baseline through week 72
At each contact with participants, study personnel non-systematically collected information on any adverse events (AEs) self-reported by participants. In addition, AEs were systematically assessed at the scheduled assessments. AEs were documented by study staff in consultation with a nurse practitioner and/or physician. Serious adverse events (SAEs) were reported immediately to the study sponsor, Data and Safety Monitor, and the Institutional Review Board.
|
1.9%
1/53 • Number of events 1 • Baseline through week 72
At each contact with participants, study personnel non-systematically collected information on any adverse events (AEs) self-reported by participants. In addition, AEs were systematically assessed at the scheduled assessments. AEs were documented by study staff in consultation with a nurse practitioner and/or physician. Serious adverse events (SAEs) were reported immediately to the study sponsor, Data and Safety Monitor, and the Institutional Review Board.
|
Additional Information
Dr. Rebecca Pearl, Assistant Professor
University of Florida
Phone: 352-294-5405
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place