Obesity & OverweightNCT07227051
Optimizing Self-Monitoring Feedback Delivery for the Treatment of Overweight and Obesity
A study testing Feedback on Calorie Goal Attainment, Feedback on Dietary Quality and Feedback on Physical Activity Goal Attainment in people with Obesity & Overweight and Obesity (Disorder), run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. 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?
- Feedback on Calorie Goal Attainment, Feedback on Dietary Quality and Feedback on Physical Activity Goal Attainment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2026to 28 Feb 2028
- 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
Advocate Aurora Research Institute
Milwaukee, Wisconsin, 53204
Tejashri Ganbote, MBA, MBBS, 414-363-1229, Tejashri.ganbote@aah.org
Kathryn M. Ross, Ph.D., M.P.H.
About this study
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.
Read the detailed description
The goal of this micro-randomized factorial trial is to learn how to best deliver self-monitoring feedback during a behavioral weight management intervention. All study participants will be provided with a "Weight Loss 101" session that provides weight loss education and behavioral skills training. At this meeting, participants will be taught how to use study-provided tools to self-monitor their dietary intake, physical activity, and weight. At the end of each week of the intervention, participants will receive an interventionist-composed feedback message based on their self-monitoring data. Every message will contain feedback about how often the participant self-monitored their dietary intake, physical activity, and weight (that is, the number of days each week that the participant monitored each) along with a message about their weight trajectory. Participants will be randomized each week to receive (or not receive) four additional feedback components each week.
The main questions that this study aims to answer are:
- which of the four additional feedback components improve adherence to self-monitoring, intervention goals, and weight loss the week after they are received?
- are there any differences in message impact depending on the person receiving the message (for example, do some messages work better for younger versus older participants) or their context (for example, are certain messages more or less helpful depending on how well the person is doing in the program)?
- Conditions
- Obesity & Overweight, Obesity (Disorder)
- Being tested
- Feedback on Calorie Goal Attainment, Feedback on Dietary Quality, Feedback on Physical Activity Goal Attainment, Goal Setting Prompt
- Keywords
- weight loss, self-monitoring, smartphone app, lifestyle intervention, digital health, mHealth, physical activity, dietary change, e-scale, wearables, activity monitor
- 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.
Feedback on Calorie Goal AttainmentBehavioural
Feedback composed by a study interventionist that focuses on the participant's progress toward meeting their caloric intake goal.
Feedback on Dietary QualityBehavioural
Feedback composed by a study interventionist that provides comments on specific dietary choices that may impact weight loss success.
Feedback on Physical Activity Goal AttainmentBehavioural
Feedback composed by a study interventionist that focuses on the participant's progress toward meeting their physical activity goal.
Goal Setting PromptBehavioural
An open-text goal setting prompt, composed by the study interventionist, that encourages the participant to set a behavioral goal for the following week.
| Study group | Role | What they receive |
|---|---|---|
| Self Monitoring Feedback | Experimental | Participants 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. Receives: Behavioral: Feedback on Calorie Goal Attainment; Behavioral: Feedback on Dietary Quality; Behavioral: Feedback on Physical Activity Goal Attainment; Behavioral: Goal Setting Prompt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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) for the week after a feedback message is received (from day 1, the day that a feedback message is received, to day 7) that a participant has a valid (non-outlier) e-scale weight.
Measured: 7 days
Frequency of self-monitoring dietary intake
A valid "day" of self-monitoring dietary intake will be defined as ≥ 800 kcal, consistent with prior research. Frequency of self-monitoring dietary intake will be defined as the number of valid days (0-7) recorded 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
Total caloric intake
Total caloric intake will be calculated by summing calories consumed 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
Calorie goal attainment
Calorie goal attainment for each day during 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 KCAL INTAKE FOR THE DAY] - [CALORIE GOAL]. Difference scores for the 7 days will be averaged over the week to assess overall adherence to the caloric intake goal during that study week.
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 received (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]. Difference scores for the 7 days 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 posted12 Nov 2025
- Study start26 Jan 2026
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (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 Wake Forest University Health SciencesThe 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. Under a 2x2x2x2 factorial design, participants will be randomized each week for 16 weeks to one of 16 conditions
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Virginia, University of Florida
- Responsible party
- Sponsor
- Investigators
- Kathryn M. Ross, Ph.D., M.P.H., Principal investigator, Aurora Research Institute LLCRebecca A. Krukowski, Ph.D., Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227051
- Sponsor's protocol ID
- IRB00135066
- Other IDs
- R01DK140099
- Status last verified
- Jan 2026
- First submitted
- 7 Nov 2025
- Last updated
- 24 Jun 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: (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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Self-Monitoring Feedback Delivery for the Treatment of Overweight and Obesity
- ClinicalTrials.gov ID
- NCT07227051
- Acronym / sponsor ID
- IRB00135066
- Conditions
- Obesity & Overweight, Obesity (Disorder)
- Keywords
- weight loss, self-monitoring, smartphone app, lifestyle intervention, digital health, mHealth, physical activity, dietary change
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Virginia, University of Florida
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 12 Nov 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 best provide weekly feedback on individual progress toward intervention goals during a weight loss program.
Detailed description
The goal of this micro-randomized factorial trial is to learn how to best deliver self-monitoring feedback during a behavioral weight management intervention. All study participants will be provided with a "Weight Loss 101" session that provides weight loss education and behavioral skills training. At this meeting, participants will be taught how to use study-provided tools to self-monitor their dietary intake, physical activity, and weight. At the end of each week of the intervention, participants will receive an interventionist-composed feedback message based on their self-monitoring data. Every message will contain feedback about how often the participant self-monitored their dietary intake, physical activity, and weight (that is, the number of days each week that the participant monitored each) along with a message about their weight trajectory. Participants will be randomized each week to receive (or not receive) four additional feedback components each week.
The main questions that this study aims to answer are:
- which of the four additional feedback components improve adherence to self-monitoring, intervention goals, and weight loss the week after they are received?
- are there any differences in message impact depending on the person receiving the message (for example, do some messages work better for younger versus older participants) or their context (for example, are certain messages more or less helpful depending on how well the person is doing in the program)?
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. Under a 2x2x2x2 factorial design, participants will be randomized each week for 16 weeks to one of 16 conditions
| Arm | Type | Receives |
|---|---|---|
| Self Monitoring Feedback | Experimental | Behavioral: Feedback on Calorie Goal Attainment, Behavioral: Feedback on Dietary Quality, Behavioral: Feedback on Physical Activity Goal Attainment, Behavioral: Goal Setting PromptParticipants 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. |
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 |
|---|---|---|
| Feedback on Calorie Goal AttainmentFeedback composed by a study interventionist that focuses on the participant's progress toward meeting their caloric intake goal. | Behavioural | Self Monitoring Feedback |
| Feedback on Dietary QualityFeedback composed by a study interventionist that provides comments on specific dietary choices that may impact weight loss success. | Behavioural | Self Monitoring Feedback |
| Feedback on Physical Activity Goal AttainmentFeedback composed by a study interventionist that focuses on the participant's progress toward meeting their physical activity goal. | Behavioural | Self Monitoring Feedback |
| Goal Setting PromptAn open-text goal setting prompt, composed by the study interventionist, that encourages the participant to set a behavioral goal for the following week. | Behavioural | Self Monitoring Feedback |
Primary outcome
Weight change
Time frame: 7 days
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 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 24 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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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.
Kathryn M. Ross, Ph.D., M.P.H. principal investigator
Aurora Research Institute LLC
Rebecca A. 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 Feedback on Calorie Goal Attainment, Feedback on Dietary Quality and Feedback on Physical Activity Goal Attainment in people with Obesity & Overweight and Obesity (Disorder), run by Wake Forest University Health Sciences 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 24 Jun 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 Tejashri Ganbote, MBA, MBBS (414-363-1229, Tejashri.ganbote@aah.org), 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 24 Jun 2026.