Weekly self-monitoring feedback and goal prompts to support weight loss
Optimizing Self-Monitoring Feedback Delivery for the Treatment of Overweight and Obesity
This trial will test different weekly feedback messages and goal prompts delivered by smartphone to see which help adults with overweight or obesity stick to tracking their diet, activity, and weight and lose more weight.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT07227051 on ClinicalTrials.gov |
What this trial studies
This micro-randomized factorial trial gives all participants a Weight Loss 101 session and tools to self-monitor diet, physical activity, and weight using a smartphone-linked scale and Fitbit. Each week participants receive a standard feedback message about how often they tracked and their weight trend, and are randomized to receive or not receive four additional feedback components (calorie goal feedback, dietary quality feedback, activity feedback, and a goal-setting prompt). The trial compares which message components improve next-week self-monitoring, goal adherence, and short-term weight change, and examines whether message effects differ by participant characteristics or context. Data are collected remotely via the app and devices, with weekly randomization of message content to build evidence for the most effective feedback strategies.
Who should consider this trial
Good fit: Adults aged 18 or older with BMI ≥25 kg/m2 who can use a compatible smartphone (iOS 16.4+ or Android 11+) and agree to use the study Fitbit and scale (and who weigh ≤175 kg) are ideal candidates.
Not a fit: People who have had or plan bariatric surgery, are using weight-loss medications, are enrolled in another weight-loss program, cannot walk briskly for 10 minutes, or do not have a compatible smartphone or scale are unlikely to be eligible or benefit from this program.
Why it matters
Potential benefit: If successful, the approach could help people improve tracking and motivation and achieve greater short-term weight loss by delivering the most helpful weekly feedback.
How similar studies have performed: Previous digital weight-loss programs show that self-monitoring and tailored feedback can produce modest weight loss, but using a micro-randomized design to optimize weekly message components is a relatively new and less-tested approach.
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
Milwaukee, Wisconsin
- Advocate Aurora Research Institute — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Kathryn M. Ross, Ph.D., M.P.H. — Aurora Research Institute LLC
- Study coordinator: Ramona Donovan, M.S.
- Email: Ramona.Donovan@aah.org
- Phone: 847-723-5792
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.