NCT07292389 · University of Virginia
Examining Valence-based Effects in Self-Monitoring Feedback Messages
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Positive Reinforcement
Feedback composed by a study interventionist that focuses exclusively on positively reinforcing the participant's progress toward achieving their goals.
BEHAVIORAL
Positive Reinforcement + Areas for Change
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.
Primary outcome measures
Weight change
Time frame: 7 days
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.
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
- 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
- Charlottesville, Virginia
Collaborators
University of Florida, Wake Forest University Health Sciences
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 Mar 31, 2026 · Source of record for eligibility and locations