Examining Valence-based Effects in Self-Monitoring Feedback Messages
1 other identifier
interventional
127
1 country
1
Brief Summary
The purpose of this research study is to learn how to identify the most effective ways to provide weekly feedback on participants' 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 P50-P75 for not_applicable
Started Mar 2026
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
December 5, 2025
CompletedFirst Posted
Study publicly available on registry
December 18, 2025
CompletedStudy Start
First participant enrolled
March 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
March 31, 2026
March 1, 2026
1.1 years
December 5, 2025
March 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight change
Mixed-effects models will be used to investigate the impact of each feedback condition on our primary outcome of weight change. Fitted model estimates will be used to calculate the slope of weight change from day 1 (the day a feedback message is delivered) through day 7 of each week. Positive slopes indicate weight gain, while negative slopes indicate 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
Study Arms (1)
Self Monitoring Feedback
EXPERIMENTALParticipants in this study will complete a 60-minute "Weight Loss 101" session and use study-provided tools to record their daily food intake, physical activity, and weight. After a one-week run-in period, they will begin receiving weekly feedback messages. The content and emphasis of these messages will differ between 2 conditions: positive reinforcement vs. positive reinforcement + areas for change.
Interventions
Feedback composed by a study interventionist that focuses exclusively on positively reinforcing the participant's progress toward achieving their goals.
Feedback provided by a study interventionist that combines positive reinforcement of the participant's progress with constructive guidance on areas for improvement to support successful goal attainment.
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
- University of Virginialead
- University of Floridacollaborator
- Wake Forest University Health Sciencescollaborator
Study Sites (1)
University of Virginia
Charlottesville, Virginia, 22901, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Becca 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
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 5, 2025
First Posted
December 18, 2025
Study Start
March 23, 2026
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
March 31, 2026
Record last verified: 2026-03
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 at the time of publication of peer-reviewed manuscript(s) based on the data.
- 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 at the time of publication of peer-reviewed manuscript(s) based on the data. 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.