The Miriam Hospital
Providence, Rhode Island, 02903, United States
Location status: Recruiting
Location contact
Jacqueline F Hayes, PhD
CONTACT
Jacqueline F Hayes, PhD
PRINCIPAL_INVESTIGATOR
CONTACT
NCT Number: NCT06994923
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.
Interested in participating?
Request Info18 year–29 year
All sexes
Interventional
Not applicable
Providence, Rhode Island, 02903, United States
Location status: Recruiting
Jacqueline F Hayes, PhD
CONTACT
Jacqueline F Hayes, PhD
PRINCIPAL_INVESTIGATOR
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Psychoeducation around dieting myths, healthy eating, and physical activity
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.
Time frame: 10 weeks
Rate of retention of 70% or more (benchmark)
Time frame: 10 weeks
Average attendance of 75% or more (benchmark)
Time frame: 10 weeks
Average weight loss of at least 3%
Contact information is provided by the study sponsor or research team.
The Miriam Hospital
Other
Testing a Behavioral Weight Loss Intervention for Emerging Adults Implemented Within College Health Service Centers
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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