Weight Management Intervention in College: A Pilot

NCT06994923 | Recruiting

• 2 other identifiers: 17937323K23DK128561
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity and Overweight

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Acceptability

  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.

  10 weeks

• Retention

  Rate of retention of 70% or more (benchmark)

  10 weeks

• Adherence

  Average attendance of 75% or more (benchmark)

  10 weeks

• Weight Loss

  Average weight loss of at least 3%

  10 weeks

Study Arms (2)

BWLI-College

EXPERIMENTAL

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.

Behavioral: BWLI-College

Control

ACTIVE COMPARATOR

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.

Behavioral: Control

Interventions

BWLI-College 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.

BWLI-College

Control BEHAVIORAL

Psychoeducation around dieting myths, healthy eating, and physical activity

Control

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Miriam Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacqueline F Hayes, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline F Hayes, PhD

CONTACT

401-793-8917; jhayes3@brownhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A 2-arm parallel randomized controlled trial

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 29, 2025
• Study Start: January 20, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-05

Locations

US (1)