Clinical trial NCT05895461: Weight Management Intervention in College: a Pilot Study
Official title: Developing a Behavioral Weight Loss Intervention for Emerging Adults Implemented Within College Health Service Centers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-06-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Acceptability
timeFrame: 10 weeks
measure: Retention
timeFrame: 10 weeks
measure: Adherence
timeFrame: 10 weeks
measure: Weight Loss
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: Brown University
name: Jacqueline F Hayes, PhD
role: PRINCIPAL_INVESTIGATOR
References: