Different weekly feedback messages to support weight loss
Examining Valence-based Effects in Self-monitoring Feedback Messages, in the Development of a Novel Semi-automated Self-monitoring Feedback System for Obesity Treatment
This project will test whether different weekly feedback messages delivered via a smartphone app help adults with overweight or obesity lose weight.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 127 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT07292389 on ClinicalTrials.gov |
What this trial studies
This micro-randomized factorial trial will randomize participants each week to receive one of two types of clinician-written feedback messages during a behavioral weight management program. All participants attend a single "Weight Loss 101" session to learn core behavioral skills and how to use study-provided tools to track diet, activity, and weight. Weekly messages vary by tone and whether they include specific suggestions for changes, and researchers will link those messages to smartphone-collected self-monitoring and weight outcomes. The design aims to identify which message components, and for whom or in which contexts, produce better engagement and weight loss.
Who should consider this trial
Good fit: Adults aged 18 or older with BMI ≥25 kg/m2 who weigh ≤175 kg, can walk briskly for at least 10 minutes, and own a Fitbit-compatible smartphone are ideal candidates.
Not a fit: People who have had or plan bariatric surgery, are using weight-loss medications or recently lost ≥10 lb, are currently in another weight-loss program, have an incompatible smartphone, or weigh more than 175 kg are unlikely to qualify or benefit from this approach.
Why it matters
Potential benefit: If successful, optimized weekly feedback messages could improve self-monitoring, boost adherence to behavior changes, and lead to greater weight loss for participants.
How similar studies have performed: Related digital self-monitoring and personalized messaging studies, including micro-randomized trials, have shown promising but mixed improvements in engagement and modest weight loss.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age greater than or equal to 18 years * BMI greater than or equal to 25.0 kg/m2 * Weight less than or equal to 175 kg (due to scale limit) * Own a smartphone compatible with Fitbit (e.g., an Apple iPhone running iOS 16.4 or higher or Android smartphone running Android 11 or higher) with a cellular and data plan Exclusion Criteria: * Weight greater than 175 kg (due to a weight limit of the study-provided scale) * Smartphone device owned deemed incompatible with the Fitbit App * History of bariatric surgery or plans to obtain bariatric surgery during the study period * Current use of weight loss medications, or use of weight loss medications in the 6 months prior to initial pre-screening * Currently participating in a weight-loss program * Weight loss of greater than or equal to 10 lbs in the 6 months prior to initial pre-screening * Physical limitations that prevent walking at a brisk pace for at least 10 minutes without stopping * Use of a pacemaker or other implanted medical device * Currently pregnant * Currently breastfeeding * Less than 1-year post-partum * Plans to become pregnant within the study period * Lack of written confirmation that the potential participant has discussed study participation with their physician if they have been diagnosed with diabetes, hypertension, or has have a history of coronary heart disease * One or more study participants living in the household (enrollment limited to one participant per household) * Medical conditions that contraindicate weight loss or prevent completion of the study (e.g., current diagnosis of cancer or terminal illness, dementia, etc.) * Recent (in the past 6 months) changes in medications that affect weight * Self-reported eating disorder within past 5 years * Unable to complete the 17-week study (due to plans to relocate during the study period, etc.) * Unable or unwilling to provide informed consent * Unable to read English at the 5th grade level * Unwilling to accept random assignment * Unable or unwilling to download the study smartphone application, wear the physical activity monitor, or use the study e-scale * Failure to complete baseline assessment measures * Failure to complete at least 4 out of 6 days of self-monitoring dietary and weight self-monitoring during the behavioral run-in period * Any other condition(s) which, in the opinion of the Principal Investigator, would adversely affect participation in the study
Where this trial is running
Charlottesville, Virginia
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Becca Krukowski, Ph.D. — University of Virginia
- Study coordinator: Maddie Glover, B.S.
- Email: ktg7zr@virginia.edu
- Phone: 4342432387
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.