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NCT Number: NCT07227051

Optimizing Self-Monitoring Feedback Delivery for the Treatment of Overweight and Obesity

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Advocate Aurora Research Institute

Milwaukee, Wisconsin, 53204, United States

Location status: Recruiting

Location contact

Kathryn M. Ross, Ph.D., M.P.H.

PRINCIPAL_INVESTIGATOR

Tejashri Ganbote, MBA, MBBS

CONTACT

[email protected]

414-363-1229

About this study

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)?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Feedback on Calorie Goal Attainment

Behavioral

Feedback composed by a study interventionist that focuses on the participant's progress toward meeting their caloric intake goal.

Feedback on Dietary Quality

Behavioral

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

Behavioral

Feedback composed by a study interventionist that focuses on the participant's progress toward meeting their physical activity goal.

Goal Setting Prompt

Behavioral

An open-text goal setting prompt, composed by the study interventionist, that encourages the participant to set a behavioral goal for the following week.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Frequency of self-monitoring weight

    Time frame: 7 days

    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.

  2. Frequency of self-monitoring dietary intake

    Time frame: 7 days

    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).

  3. Total caloric intake

    Time frame: 7 days

    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).

  4. Calorie goal attainment

    Time frame: 7 days

    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.

  5. Frequency of self-monitoring physical activity

    Time frame: 7 days

    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).

  6. Physical activity minutes

    Time frame: 7 days

    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)

  7. Physical activity goal attainment

    Time frame: 7 days

    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

Other outcomes

  1. Time to compose intervention messages (intervention costs)

    Time frame: through study completion, an average of 7 days

    Interventionists will log the time needed to compose each message (including a starting time and an ending time for each message) in our administrative dashboard

Study contacts

Contact information is provided by the study sponsor or research team.

Teace Markwalter, M.P.H., CHES

CONTACT

[email protected]

866-271-7217

Tejashri Ganbote, MBA, MBBS

CONTACT

[email protected]

414-363-1229

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Florida
  • University of Virginia

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 12, 2025
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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