Trial Outcomes & Findings for Internet Treatment for Weight Loss in Primary Care (NCT NCT01558297)
NCT ID: NCT01558297
Last Updated: 2015-07-01
Results Overview
Body weight lost in pounds measured 1.5 months after first treatment session.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
89 participants
Primary outcome timeframe
1.5 months after treatment start (Baseline)
Results posted on
2015-07-01
Participant Flow
Participant milestones
| Measure |
Motivational Interviewing
Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
|
Nutritional Counseling
Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
|
Treatment as Usual
Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
29
|
30
|
|
Overall Study
COMPLETED
|
28
|
27
|
29
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
1
|
Reasons for withdrawal
| Measure |
Motivational Interviewing
Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
|
Nutritional Counseling
Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
|
Treatment as Usual
Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
1
|
Baseline Characteristics
Internet Treatment for Weight Loss in Primary Care
Baseline characteristics by cohort
| Measure |
Motivational Interviewing
n=30 Participants
Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
|
Nutritional Counseling
n=29 Participants
Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
|
Treatment as Usual
n=30 Participants
Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.07 years
STANDARD_DEVIATION 9.97 • n=99 Participants
|
48.93 years
STANDARD_DEVIATION 11.59 • n=107 Participants
|
47.77 years
STANDARD_DEVIATION 10.05 • n=206 Participants
|
47.9 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
68 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 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
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
62 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 1.5 months after treatment start (Baseline)Population: Intent-to-treat data are presented, with the last observation carried forward, and outliers beyond 3 standard deviations replaced with highest recorded value within the 3 standard deviation range.
Body weight lost in pounds measured 1.5 months after first treatment session.
Outcome measures
| Measure |
Motivational Interviewing
n=30 Participants
Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
|
Nutritional Counseling
n=29 Participants
Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
|
Treatment as Usual
n=30 Participants
Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
|
|---|---|---|---|
|
Body Weight in Pounds.
|
-3.1 pounds
Standard Deviation 4.6
|
-3.4 pounds
Standard Deviation 5.2
|
0.1 pounds
Standard Deviation 3.5
|
PRIMARY outcome
Timeframe: 3 months after treatment start (Baseline)Population: Intent-to-treat data are presented, with the last observation carried forward, and outliers beyond 3 standard deviations replaced with highest recorded value within the 3 standard deviation range.
Body weight lost in pounds measured 3 months after first treatment session.
Outcome measures
| Measure |
Motivational Interviewing
n=30 Participants
Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
|
Nutritional Counseling
n=29 Participants
Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
|
Treatment as Usual
n=30 Participants
Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
|
|---|---|---|---|
|
Body Weight in Pounds.
|
-3.3 pounds
Standard Deviation 6.5
|
-4.9 pounds
Standard Deviation 6.1
|
-0.4 pounds
Standard Deviation 6.2
|
PRIMARY outcome
Timeframe: 6 months after treatment start (Baseline)Population: Intent-to-treat data are presented, with the last observation carried forward, and outliers beyond 3 standard deviations replaced with highest recorded value within the 3 standard deviation range.
Body weight lost in pounds measured 6 months after first treatment session (3 month follow-up after active treatment ends).
Outcome measures
| Measure |
Motivational Interviewing
n=30 Participants
Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
|
Nutritional Counseling
n=29 Participants
Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
|
Treatment as Usual
n=30 Participants
Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
|
|---|---|---|---|
|
Body Weight in Pounds.
|
-2.6 pounds
Standard Deviation 8.7
|
-5.7 pounds
Standard Deviation 9.0
|
0.4 pounds
Standard Deviation 7.2
|
Adverse Events
Motivational Interviewing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nutritional Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place