Weight Management Intervention in College: A Pilot

NCT ID: NCT06994923

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-20
• Study Completion Date: 2027-04-01

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.

Conditions

Obesity and Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BWLI-College

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 synchronous sessions. As presently designed, the intervention will last 10 weeks.

Group Type: EXPERIMENTAL

BWLI-College

Intervention Type: BEHAVIORAL

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.

Control

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.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: BEHAVIORAL

Psychoeducation around dieting myths, healthy eating, and physical activity

Interventions

BWLI-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.

Intervention Type: BEHAVIORAL

Control

Psychoeducation around dieting myths, healthy eating, and physical activity

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

The Miriam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacqueline F Hayes, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

The Miriam Hospital

Providence, Rhode Island, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jacqueline F Hayes, PhD

Role: CONTACT

jhayes3@brownhealth.org

401-793-8917

Facility Contacts

Jacqueline F Hayes, PhD

Role: primary

jhayes3@brownhealth.org

401-793-8917

Role: backup

jacqueline_hayes@brown.edu

Other Identifiers

K23DK128561

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17937323

Identifier Type: -

Identifier Source: org_study_id