Obesity & OverweightNCT07292389
Examining Valence-based Effects in Self-Monitoring Feedback Messages
A study testing Positive Reinforcement and Positive Reinforcement + Areas for Change in people with Obesity & Overweight and Obesity (Disorder), run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity & Overweight, Obesity (Disorder)
- What is being tested?
- Positive Reinforcement and Positive Reinforcement + Areas for Change
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22901
Maddie Glover, B.S., 4342432387, ktg7zr@virginia.edu
Teace Markwalter, MPH, CHES, 540-239-6283, bdwcp@virginia.edu
About this study
Official title: Examining Valence-based Effects in Self-monitoring Feedback Messages, in the Development of a Novel Semi-automated Self-monitoring Feedback System for Obesity Treatment
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.
Read the detailed description
This micro-randomized factorial trial is designed to provide information about how to optimize self-monitoring feedback within a behavioral weight management intervention. All participants will attend a "Weight Loss 101" session that covers foundational weight loss education and behavioral skills training. During this session, they will also learn how to use study-provided tools to track their dietary intake, physical activity, and weight.
Each weekly feedback message will be composed by a trained interventionist. Participants will be randomized each week to one of the two conditions to examine how the tone and composition of feedback messages impact participant behaviors and weight loss.
The main questions that this study aims to answer are:
- How does the composition of supportive feedback and ideas for potential changes in dietary or physical activity behaviors impact weight loss.
- How is this feedback affected by individual or contextual factors?
- Conditions
- Obesity & Overweight, Obesity (Disorder)
- Being tested
- Positive Reinforcement, Positive Reinforcement + Areas for Change
- Keywords
- weight loss, self-monitoring, smartphone app, lifestyle intervention, digital health, physical activity, dietary change, e-scale, wearables, activity monitor, behavior change, self-monitor activity
- Medical subject headings
- Obesity, Overweight, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive ReinforcementBehavioural
Feedback composed by a study interventionist that focuses exclusively on positively reinforcing the participant's progress toward achieving their goals.
Positive Reinforcement + Areas for ChangeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Self Monitoring Feedback | Experimental | Participants 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. Receives: Behavioral: Positive Reinforcement; Behavioral: Positive Reinforcement + Areas for Change |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (7)
Frequency of self-monitoring weight
Frequency of self-monitoring weight will be defined as the number of days (0-7) in the week following a feedback message (from day 1, the day that a feedback message is received, to day 7) in which the participant records a valid (non-outlier) e-scale weight.
Measured: 7 days
Frequency of self-monitoring dietary intake
A valid "day" of dietary self-monitoring will be defined as ≥ 800 kcal recorded, consistent with prior research. Frequency is calculated as the number of valid days (0-7) recorded the week after a feedback message is delivered (from day 1, the day that a feedback message is received, to day 7).
Measured: 7 days
Total caloric intake
Total caloric intake will be calculated by summing calories consumed during the week following a feedback message is received (from day 1, the day that a feedback message is received, to day 7)
Measured: 7 days
Calorie goal attainment
Calorie goal attainment for each day during the week after a feedback message is received (from day 1, the day a feedback message is received, to day 7). Calorie goal attainment will be calculated as [TOTAL KCAL INTAKE FOR THE DAY] - [CALORIE GOAL]. Daily difference scores for the 7 days will be averaged across the week to determine overall adherence to the caloric intake goal.
Measured: 7 days
Frequency of self-monitoring physical activity
Frequency of self-monitoring physical activity will be defined as the number of "valid" days (0-7) of Fitbit use the week after a feedback message is received (from day 1, the day that a feedback message is received, to day 7).
Measured: 7 days
Physical activity minutes
Total minutes of physical activity will be calculated by summing each days' total "active zone minutes" during the week after a feedback message is delivered (from day 1, the day that a feedback message is received, to day 7)
Measured: 7 days
Physical activity goal attainment
Physical activity goal attainment for each day of the week after a feedback message is received (from day 1, the day that a feedback message is received, to day 7) will be calculated as [TOTAL PHYSICAL ACTIVITY MINUTES] - [PHYSICAL ACTIVITY GOAL]. Daily difference scores will be averaged over the week to assess overall adherence to the physical activity goal during that study week.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start23 Mar 2026
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Micro-randomized Factorial. One of two conditions.
- Masking
- None (open label)
- Enrolment
- 127 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida, Wake Forest University Health Sciences
- Responsible party
- Principal investigator, Rebecca A. Krukowski, University of Virginia
- Investigators
- Becca Krukowski, Ph.D., Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292389
- Sponsor's protocol ID
- IRB302281
- Status last verified
- Mar 2026
- First submitted
- 5 Dec 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Valence-based Effects in Self-monitoring Feedback Messages, in the Development of a Novel Semi-automated Self-monitoring Feedback System for Obesity Treatment
- ClinicalTrials.gov ID
- NCT07292389
- Acronym / sponsor ID
- IRB302281
- Conditions
- Obesity & Overweight, Obesity (Disorder)
- Keywords
- weight loss, self-monitoring, smartphone app, lifestyle intervention, digital health, physical activity, dietary change, e-scale
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 127 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- University of Florida, Wake Forest University Health Sciences
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This micro-randomized factorial trial is designed to provide information about how to optimize self-monitoring feedback within a behavioral weight management intervention. All participants will attend a "Weight Loss 101" session that covers foundational weight loss education and behavioral skills training. During this session, they will also learn how to use study-provided tools to track their dietary intake, physical activity, and weight.
Each weekly feedback message will be composed by a trained interventionist. Participants will be randomized each week to one of the two conditions to examine how the tone and composition of feedback messages impact participant behaviors and weight loss.
The main questions that this study aims to answer are:
- How does the composition of supportive feedback and ideas for potential changes in dietary or physical activity behaviors impact weight loss.
- How is this feedback affected by individual or contextual factors?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Micro-randomized Factorial. One of two conditions.
| Arm | Type | Receives |
|---|---|---|
| Self Monitoring Feedback | Experimental | Behavioral: Positive Reinforcement, Behavioral: Positive Reinforcement + Areas for ChangeParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive ReinforcementFeedback composed by a study interventionist that focuses exclusively on positively reinforcing the participant's progress toward achieving their goals. | Behavioural | Self Monitoring Feedback |
| Positive Reinforcement + Areas for ChangeFeedback 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. | Behavioural | Self Monitoring Feedback |
Primary outcome
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.
7 secondary outcomes
Frequency of self-monitoring weight
Time frame: 7 days
Frequency of self-monitoring dietary intake
Time frame: 7 days
Total caloric intake
Time frame: 7 days
Calorie goal attainment
Time frame: 7 days
Frequency of self-monitoring physical activity
Time frame: 7 days
Physical activity minutes
Time frame: 7 days
Physical activity goal attainment
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Obesity & Overweight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Becca Krukowski, Ph.D. principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Reinforcement and Positive Reinforcement + Areas for Change in people with Obesity & Overweight and Obesity (Disorder), run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maddie Glover, B.S. (4342432387, ktg7zr@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight change (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.