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NCT Number: NCT06994923

Weight Management Intervention in College: A Pilot

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.

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Key information

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Miriam Hospital

Providence, Rhode Island, 02903, United States

Location status: Recruiting

Location contact

Jacqueline F Hayes, PhD

CONTACT

[email protected]

401-793-8917

Jacqueline F Hayes, PhD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Control

Behavioral

Psychoeducation around dieting myths, healthy eating, and physical activity

Primary outcomes

  1. Acceptability

    Time frame: 10 weeks

    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.

  2. Retention

    Time frame: 10 weeks

    Rate of retention of 70% or more (benchmark)

  3. Adherence

    Time frame: 10 weeks

    Average attendance of 75% or more (benchmark)

  4. Weight Loss

    Time frame: 10 weeks

    Average weight loss of at least 3%

Study contacts

Contact information is provided by the study sponsor or research team.

Jacqueline F Hayes, PhD

CONTACT

[email protected]

401-793-8917

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

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

Registry information

Official study title

Testing a Behavioral Weight Loss Intervention for Emerging Adults Implemented Within College Health Service Centers

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 29, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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