Weight Management Intervention in College: A Pilot Study

Study Overview
=================
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.

Detailed 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.

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

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: BWLI-College


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BWLI-College<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 80% or more (benchmark) | 10 weeks | 
| Adherence | Average attendance and completion of sessions of 75% or more (benchmark) | 10 weeks | 
| Weight Loss | Average weight loss of at least 3% (benchmark) | 10 weeks |