Optimizing Self-Monitoring Feedback for the Treatment of Obesity

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: Completed
• Conditions: Obesity; Weight Loss
• Intervention / Treatment: Behavioral: Component 1: Calorie Goal Attainment; Behavioral: Component 2: Diet Quality; Behavioral: Component 3: Physical Activity Goal Attainment; Behavioral: Component 4: Goal Setting

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: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Weight	Weight will be assessed using the study-provided e-scales	Daily throughout the study period (up to 17 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of Self-Monitoring Weight	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	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	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	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	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	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	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	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

• Sponsor: University of Florida
• Investigators: Principal Investigator: Kathryn M Ross, PhD, MPH, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2024
• Primary Completion (Actual): February 3, 2025
• Study Completion (Actual): February 3, 2025

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Body Weight Changes; Overweight; Obesity; Weight Loss
• Other Study ID 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