Optimizing Self-Monitoring Feedback Delivery for the Treatment of Overweight and Obesity
2 other identifiers
interventional
300
1 country
1
Brief Summary
The purpose of this research study is to learn how to best provide weekly feedback on individual progress toward intervention goals during a weight loss program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2025
CompletedFirst Posted
Study publicly available on registry
November 12, 2025
CompletedStudy Start
First participant enrolled
January 26, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2028
June 24, 2026
January 1, 2026
2.1 years
November 7, 2025
June 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight change
Fitted model values will then be used to estimate the slope of weight change from day 1 (the day a feedback message is received) to day 7 of each week, with positive values representing weight gain and negative values representing weight loss.
7 days
Secondary Outcomes (7)
Frequency of self-monitoring weight
7 days
Frequency of self-monitoring dietary intake
7 days
Total caloric intake
7 days
Calorie goal attainment
7 days
Frequency of self-monitoring physical activity
7 days
- +2 more secondary outcomes
Other Outcomes (1)
Time to compose intervention messages (intervention costs)
through study completion, an average of 7 days
Study Arms (1)
Self Monitoring Feedback
EXPERIMENTALParticipants enrolled in the Feedback Optimization trial will be asked to complete a 60-minute Weight Loss 101 session and to track their dietary intake, physical activity, and weight each day using study-provided tools. After the first week of self-monitoring (used as a run-in), participants will be provided with weekly feedback messages. The focus and content of these messages will vary, based on a 2x2x2x2 factorial design.
Interventions
Feedback composed by a study interventionist that focuses on the participant's progress toward meeting their caloric intake goal.
Feedback composed by a study interventionist that provides comments on specific dietary choices that may impact weight loss success.
Feedback composed by a study interventionist that focuses on the participant's progress toward meeting their physical activity goal.
An open-text goal setting prompt, composed by the study interventionist, that encourages the participant to set a behavioral goal for the following week.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.)
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator
- Wake Forest University Health Scienceslead
- University of Virginiacollaborator
- University of Floridacollaborator
Study Sites (1)
Advocate Aurora Research Institute
Milwaukee, Wisconsin, 53204, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathryn M. Ross, Ph.D., M.P.H.
Aurora Research Institute LLC
- PRINCIPAL INVESTIGATOR
Rebecca A. Krukowski, Ph.D.
University of Virginia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2025
First Posted
November 12, 2025
Study Start
January 26, 2026
Primary Completion (Estimated)
February 28, 2028
Study Completion (Estimated)
February 28, 2028
Last Updated
June 24, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- De-identified, individual-level participant data will be made available: (1) within one year from the final outcome assessment date, (2) at the time of publication of peer-reviewed manuscript(s) based on these data, or (3) at the end of the award, whichever is soonest.
- Access Criteria
- Data will be made available via the Zenodo data repository (https://zenodo.org).
Individual-level participant data will be de-identified and made available: (1) within one year from the final outcome assessment date, (2) at the time of publication of peer-reviewed manuscript(s) based on these data, or (3) at the end of the award, whichever is soonest. Study data will be shared via the Zenodo data repository at https://zenodo.org/. Analytic code will be made publicly available via Supplementary files for any publications and/or via Zenodo through a Zenodo-GitHub link. Study protocol, informed consent form, statistical analysis plan will also be available to be shared via clinicaltrials.gov.