Weight Management Intervention in College: a Pilot Study

Not Applicable

Recruiting

• Conditions: Obesity

• Registration Number: NCT05895461
• Lead Sponsor: The Miriam Hospital

Brief 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. 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 Timeline

• Study Start: 2023-05-08
• Study First Submitted: 2023-05-22
• Study First Submitted QC: 2023-05-31
• Study First Posted: 2023-06-08
• Status Verified: 2024-09
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Acceptability	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.
Retention	10 weeks	Rate of retention of 80% or more (benchmark)
Adherence	10 weeks	Average attendance and completion of sessions of 75% or more (benchmark)
Weight Loss	10 weeks	Average weight loss of at least 3% (benchmark)

Trial Locations

Locations (1)

The Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States