Weight Management Intervention in College: a Pilot Study

Last updated: October 30, 2024
Sponsor: The Miriam Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Diabetes Prevention

Treatment

Control

BWLI-College

Clinical Study ID

NCT05895461
1793732
K23DK128561
  • Ages 18-29
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • BMI of 25 or greater

  • Enrolled at college/university where study will take place

  • English-speaking

Exclusion

Exclusion Criteria:

  • History or current diagnosis of anorexia nervosa, bulimia nervosa, or alcohol usedisorder (current symptoms also assessed at screening using validated screeningquestionnaires)

  • 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 treatmentrecommendations

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Control
Phase:
Study Start date:
May 08, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • The Miriam Hospital

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.