Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID07292389

Examining Valence-based Effects in Self-monitoring Feedback Messages in the Development of a Novel Semi-automated Self-monitoring Feedback System for Obesity Treatment

Led by University of Virginia · Updated on 2026-03-31

127

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

U

University of Virginia

Lead Sponsor

U

University of Florida

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating how weekly feedback messages can best support people in a weight loss program. This study focuses on adults with obesity or overweight conditions and aims to learn how different types of feedback influence behaviors and weight loss. It is a micro-randomized factorial trial designed to improve self-monitoring feedback in a behavioral weight management intervention. Participants will first attend a 60-minute "Weight Loss 101" session covering basic weight loss education and skills. They will learn to use tools to track their food intake, physical activity, and weight. After a one-week run-in period, participants will receive weekly feedback messages created by trained interventionists. These messages will either provide positive reinforcement alone or combine positive reinforcement with suggestions for areas of change. Throughout the 17-week study, participants will regularly record their weight, diet, and physical activity using study-provided tools. Researchers will measure weight changes weekly and assess how often participants self-monitor their weight, diet, and activity. They will also track calorie intake, goal achievement, and physical activity minutes. The study includes monitoring adherence to self-monitoring and message receipt, with safety and progress evaluated during the trial.

CONDITIONS

Brief Title

Examining Valence-based Effects in Self-Monitoring Feedback Messages

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Body mass index (BMI) of 25.0 kg/m2 or higher
  • Weight 175 kg or less
  • Own a smartphone compatible with Fitbit (iPhone with iOS 16.4+ or Android with version 11+), with cellular and data plan
Not Eligible

You will not qualify if you...

  • Weight over 175 kg
  • Smartphone incompatible with Fitbit app
  • History of bariatric surgery or plans for surgery during study
  • Current or recent use (past 6 months) of weight loss medications
  • Current participation in another weight-loss program
  • Weight loss of 10 lbs or more in past 6 months
  • Physical limitations preventing brisk walking for 10 minutes
  • Use of pacemaker or implanted medical device
  • Pregnant, breastfeeding, less than 1 year postpartum, or plans to become pregnant during study
  • No physician confirmation if diagnosed with diabetes, hypertension, or coronary heart disease
  • More than one participant from the same household
  • Medical conditions that prevent weight loss or study completion (e.g., cancer, dementia)
  • Recent medication changes affecting weight
  • Eating disorder in past 5 years
  • Unable to complete 17-week study
  • Unable or unwilling to provide informed consent
  • Unable to read English at 5th grade level
  • Unwilling to accept random assignment
  • Unable or unwilling to use study app, activity monitor, or e-scale
  • Failure to complete baseline or run-in self-monitoring
  • Any condition affecting study participation as judged by the investigator

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Run-in Period

Duration - 1 week

Participants complete a one-week run-in period using study-provided tools to record their daily food intake, physical activity, and weight.

Daily self-monitoring at home

Treatment

Duration - Up to 16 weeks

Participants receive weekly feedback messages composed by a trained interventionist, focusing on positive reinforcement or positive reinforcement combined with areas for change to support weight management.

Weekly remote interactions

Trial Site Locations

Total: 1 location

1

University of Virginia

Charlottesville, Virginia, United States, 22901

Actively Recruiting

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Research Team

M

Maddie Glover, B.S.

T

Teace Markwalter, M.P.H., CHES

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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