Trial Outcomes & Findings for Healthy Me: A Program for Older Women (NCT NCT03843190)
NCT ID: NCT03843190
Last Updated: 2026-05-20
Results Overview
Percent of body weight change over 6 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
116 participants
Primary outcome timeframe
Baseline to 6 months
Results posted on
2026-05-20
Participant Flow
Participants from the feasibility period were not considered enrolled.
Participant milestones
| Measure |
Take Off Pounds Sensibly (TOPS)
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
58
|
|
Overall Study
COMPLETED
|
41
|
41
|
|
Overall Study
NOT COMPLETED
|
17
|
17
|
Reasons for withdrawal
| Measure |
Take Off Pounds Sensibly (TOPS)
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
|
Overall Study
Withdrawal by Subject
|
13
|
11
|
Baseline Characteristics
Healthy Me: A Program for Older Women
Baseline characteristics by cohort
| Measure |
Take Off Pounds Sensibly (TOPS)
n=58 Participants
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
n=58 Participants
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.78 years
STANDARD_DEVIATION 7.34 • n=30 Participants
|
67.79 years
STANDARD_DEVIATION 6.83 • n=30 Participants
|
66.78 years
STANDARD_DEVIATION 7.13 • n=60 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=30 Participants
|
58 Participants
n=30 Participants
|
116 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=30 Participants
|
56 Participants
n=30 Participants
|
114 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
58 Participants
n=30 Participants
|
58 Participants
n=30 Participants
|
116 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
58 Participants
n=30 Participants
|
58 Participants
n=30 Participants
|
116 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants with data collected at both timepoints.
Percent of body weight change over 6 months
Outcome measures
| Measure |
Take Off Pounds Sensibly (TOPS)
n=39 Participants
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
n=41 Participants
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
Weight Change
|
-2.50 percentage of body weight
Standard Deviation 3.90
|
-0.51 percentage of body weight
Standard Deviation 3.26
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Participants with data collected at each timepoint.
A measure of cardiovascular disease (CVD) risk.
Outcome measures
| Measure |
Take Off Pounds Sensibly (TOPS)
n=58 Participants
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
n=58 Participants
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
Systolic Blood Pressure (BP)
Baseline
|
137.60 mmHg
Standard Deviation 19.14
|
135.86 mmHg
Standard Deviation 15.66
|
|
Systolic Blood Pressure (BP)
3 months
|
132.15 mmHg
Standard Deviation 16.21
|
130.9 mmHg
Standard Deviation 16.47
|
|
Systolic Blood Pressure (BP)
6 months
|
132.86 mmHg
Standard Deviation 15.93
|
132.10 mmHg
Standard Deviation 15.82
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Participants with data collected at each timepoint.
A measure of cardiovascular disease (CVD) risk.
Outcome measures
| Measure |
Take Off Pounds Sensibly (TOPS)
n=58 Participants
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
n=58 Participants
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
Diastolic Blood Pressure (BP)
Baseline
|
78.16 mmHg
Standard Deviation 12.57
|
78.33 mmHg
Standard Deviation 10.28
|
|
Diastolic Blood Pressure (BP)
3 months
|
75.32 mmHg
Standard Deviation 12.08
|
76.38 mmHg
Standard Deviation 9.53
|
|
Diastolic Blood Pressure (BP)
6 months
|
76.20 mmHg
Standard Deviation 12.35
|
78.20 mmHg
Standard Deviation 9.52
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Participants with data collected at each timepoint.
A measure of cardiovascular disease (CVD) risk.
Outcome measures
| Measure |
Take Off Pounds Sensibly (TOPS)
n=54 Participants
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
n=58 Participants
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
Waist Circumference (WC)
Baseline
|
109.90 cm
Standard Deviation 12.60
|
111.87 cm
Standard Deviation 12.93
|
|
Waist Circumference (WC)
3 months
|
107.10 cm
Standard Deviation 11.96
|
111.71 cm
Standard Deviation 10.82
|
|
Waist Circumference (WC)
6 months
|
107.44 cm
Standard Deviation 10.77
|
111.22 cm
Standard Deviation 10.75
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Participants with data collected at each timepoint.
Percentage of hemoglobin that is coated with glucose. A measure of cardiovascular disease (CVD) risk.
Outcome measures
| Measure |
Take Off Pounds Sensibly (TOPS)
n=54 Participants
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
n=57 Participants
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
Hemoglobin A1c (HA1c)
6 months
|
6.20 percent glycated hemoglobin
Standard Deviation 0.93
|
6.00 percent glycated hemoglobin
Standard Deviation 0.55
|
|
Hemoglobin A1c (HA1c)
3 months
|
6.21 percent glycated hemoglobin
Standard Deviation 0.88
|
5.98 percent glycated hemoglobin
Standard Deviation 0.55
|
|
Hemoglobin A1c (HA1c)
Baseline
|
6.28 percent glycated hemoglobin
Standard Deviation 1.08
|
6.16 percent glycated hemoglobin
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Participants with data collected at each timepoint.
A measure of cardiovascular disease (CVD) risk.
Outcome measures
| Measure |
Take Off Pounds Sensibly (TOPS)
n=55 Participants
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
n=56 Participants
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
HDL (High-Density Lipoprotein) Cholesterol
Baseline
|
63.47 mg/dL
Standard Deviation 18.19
|
64.20 mg/dL
Standard Deviation 18.99
|
|
HDL (High-Density Lipoprotein) Cholesterol
3 months
|
61.71 mg/dL
Standard Deviation 16.87
|
64.03 mg/dL
Standard Deviation 20.46
|
|
HDL (High-Density Lipoprotein) Cholesterol
6 months
|
63.77 mg/dL
Standard Deviation 17.73
|
61.26 mg/dL
Standard Deviation 18.85
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Participants with data collected at each timepoint.
A measure of cardiovascular disease (CVD) risk.
Outcome measures
| Measure |
Take Off Pounds Sensibly (TOPS)
n=54 Participants
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
n=54 Participants
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
LDL (Low-Density Lipoprotein) Cholesterol, Calculated
Baseline
|
103.15 mg/dL
Standard Deviation 38.39
|
108.56 mg/dL
Standard Deviation 36.84
|
|
LDL (Low-Density Lipoprotein) Cholesterol, Calculated
3 months
|
108.29 mg/dL
Standard Deviation 37.75
|
103.49 mg/dL
Standard Deviation 34.70
|
|
LDL (Low-Density Lipoprotein) Cholesterol, Calculated
6 months
|
104.38 mg/dL
Standard Deviation 37.37
|
98.46 mg/dL
Standard Deviation 33.76
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Participants with data collected at each timepoint.
A measure of cardiovascular disease (CVD) risk.
Outcome measures
| Measure |
Take Off Pounds Sensibly (TOPS)
n=54 Participants
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
n=56 Participants
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
LDL (Low-Density Lipoprotein) Cholesterol, Direct
Baseline
|
105.04 mg/dL
Standard Deviation 37.37
|
109.89 mg/dL
Standard Deviation 38.88
|
|
LDL (Low-Density Lipoprotein) Cholesterol, Direct
3 months
|
106.03 mg/dL
Standard Deviation 37.55
|
102.67 mg/dL
Standard Deviation 34.82
|
|
LDL (Low-Density Lipoprotein) Cholesterol, Direct
6 months
|
104.51 mg/dL
Standard Deviation 37.31
|
97.77 mg/dL
Standard Deviation 32.01
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Participants with data collected at each timepoint.
A measure of cardiovascular disease (CVD) risk.
Outcome measures
| Measure |
Take Off Pounds Sensibly (TOPS)
n=55 Participants
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
n=57 Participants
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
Triglycerides
Baseline
|
113.11 mg/dL
Standard Deviation 48.82
|
138.14 mg/dL
Standard Deviation 122.63
|
|
Triglycerides
3 months
|
106.86 mg/dL
Standard Deviation 41.49
|
110.69 mg/dL
Standard Deviation 54.61
|
|
Triglycerides
6 months
|
99.05 mg/dL
Standard Deviation 38.06
|
108.62 mg/dL
Standard Deviation 51.13
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Participants with data collected at each timepoint.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
Take Off Pounds Sensibly (TOPS)
n=58 Participants
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
n=56 Participants
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - General Health
Baseline
|
72.50 score on a scale
Standard Deviation 16.66
|
73.39 score on a scale
Standard Deviation 14.59
|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - General Health
3 months
|
75.99 score on a scale
Standard Deviation 16.92
|
71.89 score on a scale
Standard Deviation 13.61
|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - General Health
6 months
|
72.71 score on a scale
Standard Deviation 17.30
|
69.76 score on a scale
Standard Deviation 17.93
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Participants with data collected at each timepoint.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
Take Off Pounds Sensibly (TOPS)
n=58 Participants
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
n=56 Participants
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Physical Functioning
Baseline
|
71.29 score on a scale
Standard Deviation 20.89
|
74.46 score on a scale
Standard Deviation 21.99
|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Physical Functioning
3 months
|
73.46 score on a scale
Standard Deviation 26.14
|
75.05 score on a scale
Standard Deviation 21.26
|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Physical Functioning
6 months
|
70.65 score on a scale
Standard Deviation 25.29
|
72.44 score on a scale
Standard Deviation 25.89
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Participants with data collected at each timepoint.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
Take Off Pounds Sensibly (TOPS)
n=58 Participants
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
n=56 Participants
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Role Functioning/Physical
Baseline
|
72.84 score on a scale
Standard Deviation 38.70
|
72.77 score on a scale
Standard Deviation 38.52
|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Role Functioning/Physical
3 months
|
73.72 score on a scale
Standard Deviation 34.86
|
72.30 score on a scale
Standard Deviation 40.30
|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Role Functioning/Physical
6 months
|
76.83 score on a scale
Standard Deviation 32.78
|
71.34 score on a scale
Standard Deviation 40.14
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Participants with data collected at each timepoint.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
Take Off Pounds Sensibly (TOPS)
n=58 Participants
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
n=56 Participants
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Role Functioning/Emotional
Baseline
|
81.03 score on a scale
Standard Deviation 31.29
|
83.93 score on a scale
Standard Deviation 33.02
|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Role Functioning/Emotional
3 months
|
80.34 score on a scale
Standard Deviation 33.96
|
77.48 score on a scale
Standard Deviation 40.87
|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Role Functioning/Emotional
6 months
|
80.49 score on a scale
Standard Deviation 34.14
|
80.49 score on a scale
Standard Deviation 36.50
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Participants with data collected at each timepoint.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
Take Off Pounds Sensibly (TOPS)
n=58 Participants
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
n=56 Participants
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Energy/Fatigue
6 months
|
68.41 score on a scale
Standard Deviation 17.55
|
65.24 score on a scale
Standard Deviation 18.40
|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Energy/Fatigue
Baseline
|
64.57 score on a scale
Standard Deviation 16.44
|
65.18 score on a scale
Standard Deviation 22.03
|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Energy/Fatigue
3 months
|
63.46 score on a scale
Standard Deviation 18.92
|
62.97 score on a scale
Standard Deviation 19.24
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Participants with data collected at each timepoint.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
Take Off Pounds Sensibly (TOPS)
n=58 Participants
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
n=56 Participants
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Emotional Well-being
Baseline
|
85.66 score on a scale
Standard Deviation 9.54
|
84.21 score on a scale
Standard Deviation 13.59
|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Emotional Well-being
3 months
|
83.49 score on a scale
Standard Deviation 13.30
|
81.73 score on a scale
Standard Deviation 15.36
|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Emotional Well-being
6 months
|
82.34 score on a scale
Standard Deviation 14.99
|
83.61 score on a scale
Standard Deviation 13.20
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Participants with data collected at each timepoint.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
Take Off Pounds Sensibly (TOPS)
n=58 Participants
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
n=56 Participants
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Social Functioning
Baseline
|
80.39 score on a scale
Standard Deviation 23.66
|
86.16 score on a scale
Standard Deviation 21.67
|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Social Functioning
3 months
|
80.45 score on a scale
Standard Deviation 25.46
|
81.08 score on a scale
Standard Deviation 25.96
|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Social Functioning
6 months
|
83.84 score on a scale
Standard Deviation 22.58
|
81.10 score on a scale
Standard Deviation 26.68
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Participants with data collected at each timepoint.
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability, i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Outcome measures
| Measure |
Take Off Pounds Sensibly (TOPS)
n=58 Participants
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
n=56 Participants
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Pain
Baseline
|
66.34 score on a scale
Standard Deviation 22.39
|
71.83 score on a scale
Standard Deviation 23.74
|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Pain
3 months
|
73.65 score on a scale
Standard Deviation 21.69
|
68.92 score on a scale
Standard Deviation 23.32
|
|
Quality of Life (QoL) as Measured by 36-item Short Form Survey (SF-36) - Pain
6 months
|
71.83 score on a scale
Standard Deviation 25.38
|
66.89 score on a scale
Standard Deviation 25.62
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Participants with data collected at each timepoint.
Number of primary care visits reported by participant in last month (baseline) or since last study visit (3 and 6 months).
Outcome measures
| Measure |
Take Off Pounds Sensibly (TOPS)
n=58 Participants
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
n=58 Participants
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
Healthcare Utilization as Measured by Number of Primary Care Visits
6 months
|
3.12 visits
Standard Deviation 3.88
|
2.98 visits
Standard Deviation 3.15
|
|
Healthcare Utilization as Measured by Number of Primary Care Visits
Baseline
|
1.02 visits
Standard Deviation 1.16
|
0.98 visits
Standard Deviation 1.18
|
|
Healthcare Utilization as Measured by Number of Primary Care Visits
3 months
|
3.98 visits
Standard Deviation 4.28
|
3.46 visits
Standard Deviation 3.75
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Participants with data collected at each timepoint.
Number of participants reporting emergency department visit(s) in last month (baseline) or since last study visit (3 and 6 months).
Outcome measures
| Measure |
Take Off Pounds Sensibly (TOPS)
n=58 Participants
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
n=58 Participants
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
Healthcare Utilization as Measured by Number of Participants With Emergency Department Visits
Baseline
|
2 Participants
|
1 Participants
|
|
Healthcare Utilization as Measured by Number of Participants With Emergency Department Visits
3 months
|
0 Participants
|
1 Participants
|
|
Healthcare Utilization as Measured by Number of Participants With Emergency Department Visits
6 months
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Participants with data collected at each timepoint.
Number of participants reporting hospitalization(s) in last month (baseline) or since last study visit (3 and 6 months).
Outcome measures
| Measure |
Take Off Pounds Sensibly (TOPS)
n=58 Participants
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
n=58 Participants
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
Healthcare Utilization as Measured by Number of Participants With Hospitalizations
Baseline
|
1 Participants
|
1 Participants
|
|
Healthcare Utilization as Measured by Number of Participants With Hospitalizations
3 months
|
2 Participants
|
1 Participants
|
|
Healthcare Utilization as Measured by Number of Participants With Hospitalizations
6 months
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Participants with data collected at each timepoint.
The Short Physical Performance Battery (SPPB) is an objective measurement instrument of balance, lower extremity strength, and functional capacity in older adults. Scores range from zero to 12 possible points. Lower scores are associated with lower function.
Outcome measures
| Measure |
Take Off Pounds Sensibly (TOPS)
n=58 Participants
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
n=58 Participants
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
Physical Function as Measured by Short Physical Performance Battery (SPPB)
Baseline
|
9.81 score on a scale
Standard Deviation 2.14
|
9.86 score on a scale
Standard Deviation 1.36
|
|
Physical Function as Measured by Short Physical Performance Battery (SPPB)
3 months
|
10.36 score on a scale
Standard Deviation 1.75
|
9.95 score on a scale
Standard Deviation 2.20
|
|
Physical Function as Measured by Short Physical Performance Battery (SPPB)
6 months
|
9.95 score on a scale
Standard Deviation 2.02
|
10.10 score on a scale
Standard Deviation 1.76
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Participants with data collected at each timepoint.
The 8-foot up-and-go test is a timed test that measures balance, agility, and speed while walking or moving. Higher times are associated with worse physical function.
Outcome measures
| Measure |
Take Off Pounds Sensibly (TOPS)
n=58 Participants
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
n=58 Participants
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
Physical Function as Measured by 8-ft Up and Go
Baseline
|
7.80 seconds
Standard Deviation 2.37
|
8.47 seconds
Standard Deviation 3.31
|
|
Physical Function as Measured by 8-ft Up and Go
3 months
|
8.29 seconds
Standard Deviation 2.95
|
7.41 seconds
Standard Deviation 1.94
|
|
Physical Function as Measured by 8-ft Up and Go
6 months
|
7.73 seconds
Standard Deviation 2.66
|
8.11 seconds
Standard Deviation 2.70
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Participants with data collected at each timepoint.
Decreased grip strength is a predictor of adverse outcomes in older adults.
Outcome measures
| Measure |
Take Off Pounds Sensibly (TOPS)
n=58 Participants
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
n=58 Participants
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
Physical Function as Measured by Isometric Hand Grip, Right Hand
Baseline
|
24.52 kg
Standard Deviation 6.48
|
26.69 kg
Standard Deviation 5.40
|
|
Physical Function as Measured by Isometric Hand Grip, Right Hand
3 months
|
27.10 kg
Standard Deviation 5.76
|
28.82 kg
Standard Deviation 5.54
|
|
Physical Function as Measured by Isometric Hand Grip, Right Hand
6 months
|
27.28 kg
Standard Deviation 6.64
|
26.96 kg
Standard Deviation 7.63
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Participants with data collected at each timepoint.
Decreased grip strength is a predictor of adverse outcomes in older adults.
Outcome measures
| Measure |
Take Off Pounds Sensibly (TOPS)
n=58 Participants
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
n=58 Participants
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
Physical Function as Measured by Isometric Hand Grip, Left Hand
Baseline
|
24.00 kg
Standard Deviation 6.28
|
26.90 kg
Standard Deviation 6.09
|
|
Physical Function as Measured by Isometric Hand Grip, Left Hand
3 months
|
27.03 kg
Standard Deviation 6.12
|
28.26 kg
Standard Deviation 5.68
|
|
Physical Function as Measured by Isometric Hand Grip, Left Hand
6 months
|
26.70 kg
Standard Deviation 5.75
|
28.57 kg
Standard Deviation 6.60
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Participants with data collected at each timepoint.
Counts the number of times a participant goes from sitting to standing in 30 seconds. Tests leg strength and endurance. Higher number associated with higher leg strength and endurance.
Outcome measures
| Measure |
Take Off Pounds Sensibly (TOPS)
n=57 Participants
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
n=57 Participants
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
Physical Function as Measured by 30 Second Chair Stands
Baseline
|
11.58 chair stands
Standard Deviation 4.33
|
11.04 chair stands
Standard Deviation 4.11
|
|
Physical Function as Measured by 30 Second Chair Stands
3 months
|
10.84 chair stands
Standard Deviation 4.53
|
11.86 chair stands
Standard Deviation 4.42
|
|
Physical Function as Measured by 30 Second Chair Stands
6 months
|
11.41 chair stands
Standard Deviation 5.26
|
12.11 chair stands
Standard Deviation 4.87
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Participants with data collected at each timepoint.
Measures distance walked in 6 minutes and assesses aerobic capacity and endurance. Higher number indicates higher aerobic capacity and endurance.
Outcome measures
| Measure |
Take Off Pounds Sensibly (TOPS)
n=58 Participants
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietitian-facilitated classes
|
Waitlist Control
n=58 Participants
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
Physical Function as Measured by 6 Minute Walk Test
Baseline
|
454.83 meters
Standard Deviation 140.97
|
442.83 meters
Standard Deviation 143.93
|
|
Physical Function as Measured by 6 Minute Walk Test
3 months
|
458.87 meters
Standard Deviation 155.62
|
464.90 meters
Standard Deviation 133.71
|
|
Physical Function as Measured by 6 Minute Walk Test
6 months
|
478.74 meters
Standard Deviation 154.09
|
479.88 meters
Standard Deviation 140.95
|
Adverse Events
Take Off Pounds Sensibly (TOPS)
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Waitlist Control
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Take Off Pounds Sensibly (TOPS)
n=58 participants at risk
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietician-facilitated classes
|
Waitlist Control
n=58 participants at risk
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
Surgical and medical procedures
Pacemaker implant
|
0.00%
0/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Infections and infestations
Hospital stay for flu
|
0.00%
0/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Surgical and medical procedures
Blood transfusion
|
0.00%
0/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Infections and infestations
Heel infection
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
0.00%
0/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Surgical and medical procedures
Surgery for heel infection
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
0.00%
0/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Surgical and medical procedures
Hernia repair
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
0.00%
0/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
Other adverse events
| Measure |
Take Off Pounds Sensibly (TOPS)
n=58 participants at risk
This group will receive TOPS intervention at the start of the study.
Take of Pounds Sensibly (TOPS): Dietician-facilitated classes
|
Waitlist Control
n=58 participants at risk
This group will be the control group for 6 months. Then at the completion of the study they will receive the vouchers to participate in TOPS chapters in the community.
Waitlist Control: At end of study, offered peer-led classes to attend.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic Cough
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
0.00%
0/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Reproductive system and breast disorders
Pelvic mass
|
0.00%
0/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Reproductive system and breast disorders
Breast concerns
|
0.00%
0/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
0.00%
0/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Cardiac disorders
Shortness of breath
|
0.00%
0/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Cardiac disorders
Dehydration
|
0.00%
0/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Cardiac disorders
Congestive heart failure
|
0.00%
0/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Gastrointestinal disorders
E Coli infection
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
0.00%
0/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
0.00%
0/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Immune system disorders
Allergy
|
0.00%
0/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Ear and labyrinth disorders
Other
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
0.00%
0/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Cardiac disorders
Increased blood pressure
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
0.00%
0/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
General disorders
|
3.4%
2/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
3.4%
2/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
6.9%
4/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
6.9%
4/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Fall
|
3.4%
2/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
0.00%
0/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Shoulder surgery after fall
|
0.00%
0/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Surgical and medical procedures
Root canal
|
0.00%
0/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Infections and infestations
Sinusitis
|
5.2%
3/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Infections and infestations
Sore throat
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Infections and infestations
Upper respiratory infection
|
3.4%
2/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
3.4%
2/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.7%
1/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
0.00%
0/58 • Up to 6 months
Participants from the feasibility period were not considered enrolled and were not monitored/assessed for Adverse Events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place