Optimizing Self-Monitoring Feedback for the Treatment of Obesity

NCT06508580 | Completed

• 1 other identifier: IRB202400735
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Weight

  Weight will be assessed using the study-provided e-scales

  Daily throughout the study period (up to 17 weeks)

Secondary Outcomes (8)

• Frequency of Self-Monitoring Weight

  Weekly throughout the study period (up to 17 weeks)

• Frequency of Self-Monitoring Dietary Intake

  Weekly throughout the study period (up to 17 weeks)

• Total Caloric Intake

  Weekly throughout the study period (up to 17 weeks)

• Calorie Goal Attainment

  Weekly throughout the study period (up to 17 weeks)

• Frequency of Self-Monitoring Physical Activity

  Weekly throughout the study period (up to 17 weeks)

Study Arms (4)

Component 1: Calorie Goal Attainment

EXPERIMENTAL

Participants will be randomized to either receive or not receive feedback based on calorie goal attainment.

Behavioral: Component 1: Calorie Goal Attainment

Component 2: Diet Quality

EXPERIMENTAL

Participants will be randomized to either receive or not receive feedback based on diet quality.

Behavioral: Component 2: Diet Quality

Component 3: Physical Activity Goal Attainment

EXPERIMENTAL

Participants will be randomized to either receive or not receive feedback based on physical activity goal attainment.

Behavioral: Component 3: Physical Activity Goal Attainment

Component 4: Goal Setting

EXPERIMENTAL

Participants will be randomized to either receive or not receive feedback based on weekly goal setting.

Behavioral: Component 4: Goal Setting

Interventions

Component 1: Calorie Goal Attainment BEHAVIORAL

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.

Component 1: Calorie Goal Attainment

Component 2: Diet Quality BEHAVIORAL

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.

Component 2: Diet Quality

Component 3: Physical Activity Goal Attainment BEHAVIORAL

On weeks that participants are randomized to receive this component, they will receive feedback related to attainment of that week's physical activity goal.

Component 3: Physical Activity Goal Attainment

Component 4: Goal Setting BEHAVIORAL

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.

Component 4: Goal Setting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Kathryn M Ross, PhD, MPH

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Micro-randomized 2x2x2x2 factorial model; participants randomized to receive or not receive one of 4 feedback conditions each week for 16 weeks

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: July 23, 2024
• Primary Completion: February 3, 2025
• Study Completion: February 3, 2025
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

US (1)