Weight Management Intervention in College: A Pilot Study

NCT05895461 | Completed Results

• 2 other identifiers: 1793732K23DK128561
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

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. Range is 1 to 5, with higher scores indicating greater acceptability.

  10 weeks

• Percentage of Participants Who Remained at 10 Weeks

  Rate of retention of 80% or more (benchmark)

  10 weeks

• Adherence

  Average attendance and completion of sessions of 75% or more (benchmark)

  10 weeks

• Weight Change

  Average weight loss of at least 3% (benchmark)

  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 asynchronous sessions. As presently designed, the intervention will last 10 weeks, though this may change with refinement.

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
• 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

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jacqueline Hayes, phD
• Organization: The Miriam Hospital

jhayes3@brownhealth.org

4017938917

Study Officials

• Jacqueline F Hayes, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The first 3 cohorts of this study were a single group pre-post design. Based on findings from those, the fourth cohort was changed to include a control group (arm 2). A control group was not originally planned until the next phase of the study; however, it was included at this stage in order to put achievement of weight benchmarks into context and inform potential progression decision-making.

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 8, 2023
• Study Start: May 8, 2023
• Primary Completion: December 5, 2024
• Study Completion: December 5, 2024
• Last Updated: January 21, 2026
• Results First Posted: January 21, 2026

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)