Recruiting

Weight Management

Sponsor:

The Miriam Hospital

Code:

NCT06994923

Conditions

Obesity and Overweight

Eligibility Criteria

Sex: All

Age: 18 - 29

Healthy Volunteers: Not accepted

Interventions

BWLI-College

Control

Study Details

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

Study ID

NCT06994923

Start date

Jan 20, 2025

Status verified date

May, 2025

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 29

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

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.

Control

Psychoeducation around dieting myths, healthy eating, and physical activity

Primary outcome measure

  • Acceptability [ Time Frame: 10 weeks ]
  • Retention [ Time Frame: 10 weeks ]
  • Adherence [ Time Frame: 10 weeks ]
  • Weight Loss [ Time Frame: 10 weeks ]

Central Contacts and Locations

Central contacts

Jacqueline F Hayes, PhD

401-793-8917jhayes3@brownhealth.org

Locations

The Miriam Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Jacqueline F Hayes, PhD

401-793-8917jhayes3@brownhealth.org

jacqueline_hayes@brown.edu

Principal Investigator:

Jacqueline F Hayes, PhD

More Information

Sponsor

The Miriam Hospital

Last update posted

Oct 1, 2025

Last verified

May, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Miriam Hospital on 2025-10-01.