Weight Management Intervention in College: A Pilot Study

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05895461
• Other study ID #: 1793732
• Status: Recruiting
• Phase: N/A
• Start date: May 8, 2023
• Est. completion date: August 2024

Study information

• Verified date: May 2023
• Source: The Miriam Hospital
• Contact: Jacqueline F Hayes, PhD
• Phone: 401-793-8917
• Email: jhayes3[@]lifespan.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 proof-of-concept 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 proof-of-concept study is to iteratively test and refine the intervention to maximize student acceptability and weight loss outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

• 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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Retention	Rate of retention of 80% or more (benchmark)	10 weeks
Primary	Adherence	Average attendance and completion of sessions of 75% or more (benchmark)	10 weeks
Primary	Weight Loss	Average weight loss of at least 3% (benchmark)	10 weeks