Clinical trial NCT06994923: Weight Management Intervention in College: A Pilot RCT
Official title: Developing a Behavioral Weight Loss Intervention for Emerging Adults Implemented Within College Health Service Centers: A Pilot RCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity and Overweight
Keywords: obesity
college students
behavioral weight loss intervention
small changes
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2025-05-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A 2-arm parallel randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability
timeFrame: 10 weeks
measure: Retention
timeFrame: 10 weeks
measure: Adherence
timeFrame: 10 weeks
measure: Weight Loss
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: Brown University
name: Jacqueline F Hayes, PhD
role: PRINCIPAL_INVESTIGATOR
References: