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Weight Management Intervention in College: A Pilot

Testing a Behavioral Weight Loss Intervention for Emerging Adults Implemented Within College Health Service Centers

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06994923
Enrollment
60
Registered
2025-05-29
Start date
2025-01-20
Completion date
2027-04-01
Last updated
2025-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity and Overweight

Keywords

obesity, college students, behavioral weight loss intervention, small changes

Brief summary

This pilot randomized controlled trial will examine a behavioral weight loss intervention that uses a small change approach fro emerging adult college students with overweight/obesity. The primary aim is to assess student acceptability and clinically-meaningful weight changes.

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 randomized controlled pilot 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 substudy is to assess acceptability and feasibility of the intervention and to get a preliminary understanding of potential clinical benefit for participants.

Interventions

BEHAVIORALBWLI-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.

BEHAVIORALControl

Psychoeducation around dieting myths, healthy eating, and physical activity

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
The Miriam Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

A 2-arm parallel randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
No

Inclusion criteria

* BMI of 25 or greater * Enrolled at college/university where study will take place * English-speaking

Exclusion criteria

* 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 or current utilization of obesity medications * 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

Design outcomes

Primary

MeasureTime frameDescription
Acceptability10 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.
Retention10 weeksRate of retention of 70% or more (benchmark)
Adherence10 weeksAverage attendance of 75% or more (benchmark)
Weight Loss10 weeksAverage weight loss of at least 3%

Countries

United States

Contacts

Primary ContactJacqueline F Hayes, PhD
jhayes3@brownhealth.org401-793-8917

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026