Trial Outcomes & Findings for Weight Management Intervention in College: A Pilot Study (NCT NCT05895461)
NCT ID: NCT05895461
Last Updated: 2026-01-21
Results Overview
Refers to the satisfactory nature of a treatment and will be assessed via the 4-item Acceptability of Intervention Measure. Benchmarks are to reach mean scores of at least 4 out of 5. Range is 1 to 5, with higher scores indicating greater acceptability.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
10 weeks
Results posted on
2026-01-21
Participant Flow
Recruitment in this trial followed college semesters, starting in Summer 2023 and ending in Fall 2024.
While 42 signed the consent, n=6 were unable to participate due to their scheduling (i.e., their schedule did not allow for them to participate at the selected time) and n=2 were lost to follow-up prior to initiating treatment and learning of treatment condition.
Participant milestones
| Measure |
BWLI-College
BWLI-College is a multicomponent behavioral weight loss intervention to reduce weight through diet, physical activity, and behavioral modifications designed to be responsive to emerging adult preferences. It will be delivered in a hybrid format with in-person and remotely-delivered asynchronous sessions. As presently designed, the intervention will last 10 weeks, though this may change with refinement.
BWLI-College: Behavioral modifications are based on empirically-supported principles for weight loss.
Diet recommendations follow a small change approach in which participants will make a series of small, self-selected dietary changes each day (\~100-200 calories) that they build on over the course of the intervention.
Physical activity recommendations are to achieve 150-250 weekly minutes of moderate-to-vigorous physical activity with specific goals and rate of progression that are individualized to each participant.
|
Control
The Control intervention consists of 1 in-person psychoeducational group session on general weight loss information and myths. Public web-resources about healthy eating and physical activity will be provided. Newsletters with similar content will be sent to promote retention.
Control: Psychoeducation around dieting myths, healthy eating, and physical activity
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
5
|
|
Overall Study
COMPLETED
|
24
|
5
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Weight Management Intervention in College: A Pilot Study
Baseline characteristics by cohort
| Measure |
BWLI-College
n=29 Participants
BWLI-College is a multicomponent behavioral weight loss intervention to reduce weight through diet, physical activity, and behavioral modifications designed to be responsive to emerging adult preferences. It will be delivered in a hybrid format with in-person and remotely-delivered asynchronous sessions. As presently designed, the intervention will last 10 weeks, though this may change with refinement.
BWLI-College: Behavioral modifications are based on empirically-supported principles for weight loss.
Diet recommendations follow a small change approach in which participants will make a series of small, self-selected dietary changes each day (\~100-200 calories) that they build on over the course of the intervention.
Physical activity recommendations are to achieve 150-250 weekly minutes of moderate-to-vigorous physical activity with specific goals and rate of progression that are individualized to each participant.
|
Control
n=5 Participants
The Control intervention consists of 1 in-person psychoeducational group session on general weight loss information and myths. Public web-resources about healthy eating and physical activity will be provided. Newsletters with similar content will be sent to promote retention.
Control: Psychoeducation around dieting myths, healthy eating, and physical activity
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=37 Participants
|
5 Participants
n=44 Participants
|
34 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=37 Participants
|
1 Participants
n=44 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
5 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=37 Participants
|
3 Participants
n=44 Participants
|
22 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=37 Participants
|
1 Participants
n=44 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=37 Participants
|
2 Participants
n=44 Participants
|
10 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=37 Participants
|
3 Participants
n=44 Participants
|
24 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
|
Weight Category
Overweight
|
6 Participants
n=37 Participants
|
1 Participants
n=44 Participants
|
7 Participants
n=40 Participants
|
|
Weight Category
Obese
|
23 Participants
n=37 Participants
|
4 Participants
n=44 Participants
|
27 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=37 Participants
|
3 Participants
n=44 Participants
|
29 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=37 Participants
|
2 Participants
n=44 Participants
|
5 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 10 weeksRefers to the satisfactory nature of a treatment and will be assessed via the 4-item Acceptability of Intervention Measure. Benchmarks are to reach mean scores of at least 4 out of 5. Range is 1 to 5, with higher scores indicating greater acceptability.
Outcome measures
| Measure |
BWLI-College
n=24 Participants
BWLI-College is a multicomponent behavioral weight loss intervention to reduce weight through diet, physical activity, and behavioral modifications designed to be responsive to emerging adult preferences. It will be delivered in a hybrid format with in-person and remotely-delivered asynchronous sessions. As presently designed, the intervention will last 10 weeks, though this may change with refinement.
|
Control
n=5 Participants
The Control intervention consists of 1 in-person psychoeducational group session on general weight loss information and myths. Public web-resources about healthy eating and physical activity will be provided. Newsletters with similar content will be sent to promote retention.
|
|---|---|---|
|
Acceptability
|
4.6 score
Standard Deviation 0.5
|
4.2 score
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: 10 weeksRate of retention of 80% or more (benchmark)
Outcome measures
| Measure |
BWLI-College
n=29 Participants
BWLI-College is a multicomponent behavioral weight loss intervention to reduce weight through diet, physical activity, and behavioral modifications designed to be responsive to emerging adult preferences. It will be delivered in a hybrid format with in-person and remotely-delivered asynchronous sessions. As presently designed, the intervention will last 10 weeks, though this may change with refinement.
|
Control
n=5 Participants
The Control intervention consists of 1 in-person psychoeducational group session on general weight loss information and myths. Public web-resources about healthy eating and physical activity will be provided. Newsletters with similar content will be sent to promote retention.
|
|---|---|---|
|
Percentage of Participants Who Remained at 10 Weeks
|
24 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 10 weeksAverage attendance and completion of sessions of 75% or more (benchmark)
Outcome measures
| Measure |
BWLI-College
n=24 Participants
BWLI-College is a multicomponent behavioral weight loss intervention to reduce weight through diet, physical activity, and behavioral modifications designed to be responsive to emerging adult preferences. It will be delivered in a hybrid format with in-person and remotely-delivered asynchronous sessions. As presently designed, the intervention will last 10 weeks, though this may change with refinement.
|
Control
n=5 Participants
The Control intervention consists of 1 in-person psychoeducational group session on general weight loss information and myths. Public web-resources about healthy eating and physical activity will be provided. Newsletters with similar content will be sent to promote retention.
|
|---|---|---|
|
Adherence
|
77.5 percent sessions attended
Standard Deviation 20.2
|
80 percent sessions attended
Standard Deviation 44.7
|
PRIMARY outcome
Timeframe: 10 weeksAverage weight loss of at least 3% (benchmark)
Outcome measures
| Measure |
BWLI-College
n=24 Participants
BWLI-College is a multicomponent behavioral weight loss intervention to reduce weight through diet, physical activity, and behavioral modifications designed to be responsive to emerging adult preferences. It will be delivered in a hybrid format with in-person and remotely-delivered asynchronous sessions. As presently designed, the intervention will last 10 weeks, though this may change with refinement.
|
Control
n=5 Participants
The Control intervention consists of 1 in-person psychoeducational group session on general weight loss information and myths. Public web-resources about healthy eating and physical activity will be provided. Newsletters with similar content will be sent to promote retention.
|
|---|---|---|
|
Weight Change
|
-1.7 percent change
Standard Deviation 2.8
|
0.7 percent change
Standard Deviation 3.4
|
Adverse Events
BWLI-College
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BWLI-College
n=29 participants at risk
BWLI-College is a multicomponent behavioral weight loss intervention to reduce weight through diet, physical activity, and behavioral modifications designed to be responsive to emerging adult preferences. It will be delivered in a hybrid format with in-person and remotely-delivered asynchronous sessions. As presently designed, the intervention will last 10 weeks, though this may change with refinement.
BWLI-College: Behavioral modifications are based on empirically-supported principles for weight loss.
Diet recommendations follow a small change approach in which participants will make a series of small, self-selected dietary changes each day (\~100-200 calories) that they build on over the course of the intervention.
Physical activity recommendations are to achieve 150-250 weekly minutes of moderate-to-vigorous physical activity with specific goals and rate of progression that are individualized to each participant.
|
Control
n=5 participants at risk
The Control intervention consists of 1 in-person psychoeducational group session on general weight loss information and myths. Public web-resources about healthy eating and physical activity will be provided. Newsletters with similar content will be sent to promote retention.
Control: Psychoeducation around dieting myths, healthy eating, and physical activity
|
|---|---|---|
|
Psychiatric disorders
Treatment initiation or change
|
10.3%
3/29 • from enrollment until end of follow-up, up to 10 weeks
Collection approach was non-systematic for initial cohorts and a questionnaire (systematic) process was added.
|
40.0%
2/5 • from enrollment until end of follow-up, up to 10 weeks
Collection approach was non-systematic for initial cohorts and a questionnaire (systematic) process was added.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place