Optimizing Self-Monitoring Feedback for the Treatment of Obesity

April 4, 2025 updated by: University of Florida

Optimizing Self-Monitoring Feedback Delivery for the Treatment of Obesity

Self-monitoring (of weight, intake, and activity) is a core component in evidence-based lifestyle interventions for obesity. Research has shown that interventionist feedback increases adherence to self-monitoring and improves weight loss outcomes; however, little empirical evidence exists on how this feedback should be provided. This research study aims to optimize the provision of self-monitoring feedback.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Self-monitoring (e.g., of weight, dietary intake, and physical activity) is a core component in evidence-based comprehensive lifestyle interventions for obesity, and greater adherence to self-monitoring has been associated both with better short-term weight loss and long-term weight loss maintenance. Importantly, research has demonstrated that the provision of interventionist feedback on self-monitoring increases adherence to self-monitoring and improves weight loss outcomes. Little empirical evidence exists, however, to provide guidance on how this feedback should be provided. One study conducted in this area demonstrated that intentions to self-monitor differ by feedback complexity, such that too little (and, conversely, too much) feedback reduces future intentions to self-monitor and engage in related health behavior change; however, less is known regarding how the type and complexity of feedback messages affect actual self-monitoring behavior and subsequent weight loss outcomes. Importantly, provision of this feedback also represents a substantial investment of clinician time; research demonstrated that feedback messages incorporating self-monitoring data related to weight, dietary intake, and physical activity can take ~26 minutes per person to compose. Thus, the investigators propose a line of research that aims to optimize the provision of self-monitoring feedback (i.e., identifying the optimal number and type of feedback messages) for supporting adherence to weight-management behaviors. For the current study, the investigators propose to assess the feasibility and acceptability of a micro-randomized, factorial trial design that will ultimately be used (in a future, fully-powered trial) evaluate the proximal impact of different types and amount of feedback on change in weight and weight-related behaviors (e.g., adherence to self-monitoring, caloric goal attainment, physical activity goal attainment). Using a 2x2x2x2 factorial model, participants will be randomized each week for 16 weeks to one of 16 possible feedback conditions, allowing us to efficiently test four feedback components (i.e., feedback on calorie goal attainment, dietary quality, physical activity goal attainment, or on goal setting) in one study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Meena N Shankar, MS, RD, CCRC
  • Phone Number: 352-273-5235
  • Email: mns@phhp.ufl.edu

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • BMI ≥ 30.0 kg/m2
  • ≤ 175 kg (due to scale limit)
  • Own a smartphone (Apple iPhone running iOS 15 or higher or Android smartphone running Android 10 or higher) with a cellular and data plan

Exclusion Criteria:

  • Weight > 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 ≥ 10 lbs in the 6 months prior to initial pre-screening
  • Physical limitations that prevent walking 1/4 mile 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 approval for participation from potential participant's physician if the participant has been diagnosed with diabetes, hypertension, or has 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.)
  • 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 applications, wear the physical activity monitor, or use the study e-scale
  • Failure to complete baseline assessment measures
  • Failure to complete at least 5 out of 7 days of self-monitoring dietary and weight self-monitoring during the behavioral run-in period
  • Other conditions which in the opinion of the Principal Investigator would adversely affect participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Component 1: Calorie Goal Attainment
Participants will be randomized to either receive or not receive feedback based on calorie goal attainment.
Behavioral: Component 1: Calorie Goal Attainment
On weeks that participants are randomized to receive this component, they will be provided with feedback on the number of days that they met their calorie goal.
Experimental: Component 2: Diet Quality
Participants will be randomized to either receive or not receive feedback based on diet quality.
Behavioral: Component 2: Diet Quality
On weeks that participants are randomized to receive this component, they will receive three comments regarding specific dietary choices that may impact weight loss success, including reinforcing comments for behaviors consistent with weight loss and potential areas for change.
Experimental: Component 3: Physical Activity Goal Attainment
Participants will be randomized to either receive or not receive feedback based on physical activity goal attainment.
Behavioral: Component 3: Physical Activity Goal Attainment
On weeks that participants are randomized to receive this component, they will receive feedback related to attainment of that week's physical activity goal.
Experimental: Component 4: Goal Setting
Participants will be randomized to either receive or not receive feedback based on weekly goal setting.
Behavioral: Component 4: Goal Setting
On weeks that participants are randomized to receive the goal setting component, they will be asked to complete an open-text prompt encouraging them to set a specific weight-related behavior change goal for the next week.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: Daily throughout the study period (up to 17 weeks)
Weight will be assessed using the study-provided e-scales
Daily throughout the study period (up to 17 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency of Self-Monitoring Weight
Time Frame: Weekly throughout the study period (up to 17 weeks)
Frequency of self-monitoring of weight will be defined as the number of days (0-7) each study week that a participant had a valid (e.g., non-outlier) weight recorded via the study-provided e-scale.
Weekly throughout the study period (up to 17 weeks)
Frequency of Self-Monitoring Dietary Intake
Time Frame: Weekly throughout the study period (up to 17 weeks)
A valid "day" of self-monitoring dietary intake will be defined as ≥ 800 kcal recorded via the Fitbit app or website, consistent with prior research. For each study week, frequency of self-monitoring dietary intake will be defined as the number of valid days (0-7) recorded.
Weekly throughout the study period (up to 17 weeks)
Total Caloric Intake
Time Frame: Weekly throughout the study period (up to 17 weeks)
For each study week, total caloric intake will be calculated by summing calories recorded via the Fitbit app or website each day of that week between 12:00 AM and 11:59 PM local time.
Weekly throughout the study period (up to 17 weeks)
Calorie Goal Attainment
Time Frame: Weekly throughout the study period (up to 17 weeks)
Calorie goal attainment each day of the week will be calculated as [TOTAL KCAL INTAKE FOR THE DAY] - [CALORIE GOAL], using calorie data recorded via the Fitbit app or website. Difference scores for the 7 days will be averaged over the week to assess overall adherence to the caloric intake goal during each study week.
Weekly throughout the study period (up to 17 weeks)
Frequency of Self-Monitoring Physical Activity
Time Frame: Weekly throughout the study period (up to 17 weeks)
Consistent with the broader accelerometry literature, a "valid day" of self-monitoring physical activity will be defined as a day with ≥10 hours of Fitbit wear time, assessed as minutes of non-zero heart rate measurements captured by the Fitbit device. For each study week, frequency of self-monitoring physical activity will be defined as the number of "valid" days (0-7) of Fitbit use.
Weekly throughout the study period (up to 17 weeks)
Physical Activity Minutes
Time Frame: Weekly throughout the study period (up to 17 weeks)
For each study week, total minutes of physical activity will be calculated by summing the total "active zone minutes" recorded via a Fitbit activity monitor for each day of the week.
Weekly throughout the study period (up to 17 weeks)
Physical Activity Goal Attainment
Time Frame: Weekly throughout the study period (up to 17 weeks)
For each study week, physical activity goal attainment will be calculated as [TOTAL PHYSICAL ACTIVITY MINUTES] - [PHYSICAL ACTIVITY GOAL], with physical activity minutes recorded via a Fitbit activity monitor.
Weekly throughout the study period (up to 17 weeks)
Feedback Message Acceptability
Time Frame: Weekly throughout the study period (up to 17 weeks)
Participants will be asked to rate the helpfulness of feedback messages received each week by selecting a "thumbs up" or "thumbs down" button displayed beneath the message.
Weekly throughout the study period (up to 17 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kathryn M Ross, PhD, MPH, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 23, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 3, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 3, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB202400735

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be shared upon request following the establishment of an appropriate data use agreement.

IPD Sharing Time Frame

The proposed study is a pilot for a larger trial; we will share data from the pilot within one year of completion of the larger trial.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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