ObesityNCT05895461
Weight Management Intervention in College: A Pilot Study
A study testing BWLI-College in people with Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
This Proof-of-Concept study consists of a series of uncontrolled pilot studies to refine a behavioral weight loss trial using a "small change" approach for emerging adult college students with overweight/obesity. Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Obesity
- What is being tested?
- BWLI-College
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2023to 5 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI of 25 or greater
- Enrolled at college/university where study will take place
- English-speaking
Who cannot join
- History or current diagnosis of anorexia nervosa, bulimia nervosa, or alcohol use disorder (current symptoms also assessed at screening using validated screening questionnaires)
- Participation in another formal weight loss program
- Current or recent pregnancy
- Psychiatric hospitalization in the past 12 months
- Recent weight loss of 5% body weight or more
- History of bariatric surgery
- Severe food or physical activity restrictions that would interfere with treatment recommendations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing a Behavioral Weight Loss Intervention for Emerging Adults Implemented Within College Health Service Centers
This Proof-of-Concept study consists of a series of uncontrolled pilot studies to refine a behavioral weight loss trial using a "small change" approach for emerging adult college students with overweight/obesity. The primary aim of this study is maximize student acceptability of the intervention and weight loss outcomes.
Read the detailed description
Forty percent of emerging adults (age 18-25) have overweight or obesity, which is unlikely to remit and has significant health consequences. However, emerging adults are underrepresented in traditional weight loss programs, drop-out at high rates, and have blunted weight loss outcomes. One potential way to improve participation is to offer BWLIs in college health service centers to reduce barriers to participation. Approximately 40% of emerging adults are enrolled in a postsecondary institution and college health centers are used widely by students. Moreover, delivering an intervention with design features that are responsive to emerging adult preferences and lifestyles may also improve intervention effectiveness and attractiveness. The "small change" (SC) approach to weight loss addresses emerging adult barriers to engagement by focusing on reducing calories through a few self-selected, specific changes to current obesogenic behaviors, requiring less time and effort than traditional behavioral weight loss interventions (BWLI) and promoting autonomy and self-efficacy. The SC approach has been used effectively for weight loss in other populations. This proof-of-concept study is part of a larger study that aims to develop and refine a novel and effective BWLI based on a SC approach that is designed for emerging adults and for implementation in college health centers, an accessible care setting. The primary aim of this proof-of-concept study is to iteratively test and refine the intervention to maximize student acceptability and weight loss outcomes.
- Conditions
- Obesity
- Being tested
- BWLI-College, Control
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BWLI-CollegeBehavioural
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.
ControlBehavioural
Psychoeducation around dieting myths, healthy eating, and physical activity
| Study group | Role | What they receive |
|---|---|---|
| BWLI-College | Experimental | 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. Receives: Behavioral: BWLI-College |
| Control | Active comparator | 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
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.
Measured: 10 weeks
Percentage of Participants Who Remained at 10 Weeks
Rate of retention of 80% or more (benchmark)
Measured: 10 weeks
Adherence
Average attendance and completion of sessions of 75% or more (benchmark)
Measured: 10 weeks
Weight Change
Average weight loss of at least 3% (benchmark)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start8 May 2023
- Primary completion5 Dec 2024
- Study completion5 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The first 3 cohorts of this study were a single group pre-post design. Based on findings from those, the fourth cohort was changed to include a control group (arm 2). A control group was not originally planned until the next phase of the study; however, it was included at this stage in order to put achievement of weight benchmarks into context and inform potential progression decision-making.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacqueline F Hayes, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895461
- Sponsor's protocol ID
- 1793732
- Other IDs
- K23DK128561
- Status last verified
- Sep 2024
- First submitted
- 22 May 2023
- Last updated
- 21 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to share with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Behavioral Weight Loss Intervention for Emerging Adults Implemented Within College Health Service Centers
- ClinicalTrials.gov ID
- NCT05895461
- Acronym / sponsor ID
- 1793732
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 8 May 2023 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 8 Jun 2023 (actual)
- Results
- Posted 21 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Proof-of-Concept study consists of a series of uncontrolled pilot studies to refine a behavioral weight loss trial using a "small change" approach for emerging adult college students with overweight/obesity. The primary aim of this study is maximize student acceptability of the intervention and weight loss outcomes.
Detailed description
Forty percent of emerging adults (age 18-25) have overweight or obesity, which is unlikely to remit and has significant health consequences. However, emerging adults are underrepresented in traditional weight loss programs, drop-out at high rates, and have blunted weight loss outcomes. One potential way to improve participation is to offer BWLIs in college health service centers to reduce barriers to participation. Approximately 40% of emerging adults are enrolled in a postsecondary institution and college health centers are used widely by students. Moreover, delivering an intervention with design features that are responsive to emerging adult preferences and lifestyles may also improve intervention effectiveness and attractiveness. The "small change" (SC) approach to weight loss addresses emerging adult barriers to engagement by focusing on reducing calories through a few self-selected, specific changes to current obesogenic behaviors, requiring less time and effort than traditional behavioral weight loss interventions (BWLI) and promoting autonomy and self-efficacy. The SC approach has been used effectively for weight loss in other populations. This proof-of-concept study is part of a larger study that aims to develop and refine a novel and effective BWLI based on a SC approach that is designed for emerging adults and for implementation in college health centers, an accessible care setting. The primary aim of this proof-of-concept study is to iteratively test and refine the intervention to maximize student acceptability and weight loss outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The first 3 cohorts of this study were a single group pre-post design. Based on findings from those, the fourth cohort was changed to include a control group (arm 2). A control group was not originally planned until the next phase of the study; however, it was included at this stage in order to put achievement of weight benchmarks into context and inform potential progression decision-making.
| Arm | Type | Receives |
|---|---|---|
| BWLI-College | Experimental | Behavioral: BWLI-CollegeBWLI-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 | Active comparator | Behavioral: ControlThe 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. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI of 25 or greater
- Enrolled at college/university where study will take place
- English-speaking
Key exclusion criteria (7 listed)
- History or current diagnosis of anorexia nervosa, bulimia nervosa, or alcohol use disorder (current symptoms also assessed at screening using validated screening questionnaires)
- Participation in another formal weight loss program
- Current or recent pregnancy
- Psychiatric hospitalization in the past 12 months
- Recent weight loss of 5% body weight or more
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BWLI-CollegeBehavioral 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. | Behavioural | BWLI-College |
| ControlPsychoeducation around dieting myths, healthy eating, and physical activity | Behavioural | Control |
Primary outcome
Acceptability
Time frame: 10 weeks
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.
Percentage of Participants Who Remained at 10 Weeks
Time frame: 10 weeks
Rate of retention of 80% or more (benchmark)
Adherence
Time frame: 10 weeks
Average attendance and completion of sessions of 75% or more (benchmark)
Weight Change
Time frame: 10 weeks
Average weight loss of at least 3% (benchmark)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to share with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline F Hayes, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BWLI-College in people with Obesity, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: 10 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026; AzTrials last refreshed its copy on 28 Oct 2026.