Optimizing Self-Monitoring Feedback Delivery for the Treatment of Overweight and Obesity
NCT ID: NCT07227051
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
300 participants
INTERVENTIONAL
2026-02-01
2028-02-28
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Self Monitoring Feedback
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.
Feedback on Calorie Goal Attainment
Feedback composed by a study interventionist that focuses on the participant's progress toward meeting their caloric intake goal.
Feedback on Dietary Quality
Feedback composed by a study interventionist that provides comments on specific dietary choices that may impact weight loss success.
Feedback on Physical Activity Goal Attainment
Feedback composed by a study interventionist that focuses on the participant's progress toward meeting their physical activity goal.
Goal Setting Prompt
An open-text goal setting prompt, composed by the study interventionist, that encourages the participant to set a behavioral goal for the following week.
Interventions
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Feedback on Calorie Goal Attainment
Feedback composed by a study interventionist that focuses on the participant's progress toward meeting their caloric intake goal.
Feedback on Dietary Quality
Feedback composed by a study interventionist that provides comments on specific dietary choices that may impact weight loss success.
Feedback on Physical Activity Goal Attainment
Feedback composed by a study interventionist that focuses on the participant's progress toward meeting their physical activity goal.
Goal Setting Prompt
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
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Virginia
OTHER
University of Florida
OTHER
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Kathryn M. Ross, Ph.D., M.P.H.
Role: PRINCIPAL_INVESTIGATOR
Aurora Research Institute LLC
Rebecca A. Krukowski, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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Advocate Aurora Research Institute
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Ramona Donovan, M.S.
Role: primary
Other Identifiers
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IRB00135066
Identifier Type: -
Identifier Source: org_study_id