NCT06994923 · The Miriam Hospital
Weight Management Intervention in College: A Pilot
What this study is about
This pilot randomly assigned 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.
View original scientific description
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.
Interventions
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.
BEHAVIORAL
Control
Psychoeducation around dieting myths, healthy eating, and physical activity
Primary outcome measures
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.
Retention
Time frame: 10 weeks
Rate of retention of 70% or more (benchmark)
Adherence
Time frame: 10 weeks
Average attendance of 75% or more (benchmark)
Weight Loss
Time frame: 10 weeks
Average weight loss of at least 3%
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Providence, Rhode Island
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 1, 2025 · Source of record for eligibility and locations