Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT07227051

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

Led by Wake Forest University Health Sciences · Updated on 2026-04-13

300

Participants Needed

1

Research Sites

109 weeks

Total Duration

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Sponsors

W

Wake Forest University Health Sciences

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than or equal to 18 years
  • Body mass index (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., iPhone with iOS 16.4+ or Android 11+) with a cellular and data plan
Not Eligible

You will not qualify if you...

  • Weight greater than 175 kg due to scale limit
  • Own a smartphone incompatible with the Fitbit app
  • History of or planned bariatric surgery during the study
  • Current or recent (past 6 months) use of weight loss medications
  • Currently participating in a weight-loss program
  • Weight loss of 10 lbs or more in the past 6 months
  • Physical limitations preventing brisk walking for at least 10 minutes without stopping
  • Use of pacemaker or implanted medical device
  • Currently pregnant, breastfeeding, less than 1 year postpartum, or planning pregnancy during study
  • No written confirmation of physician discussion if diagnosed with diabetes, hypertension, or coronary heart disease
  • More than one participant from the same household
  • Medical conditions contraindicating weight loss or study completion (e.g., cancer, terminal illness, dementia)
  • Recent medication changes affecting weight
  • Self-reported eating disorder within past 5 years
  • Unable to complete 17-week study (e.g., due to relocation)
  • 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, physical activity monitor, or e-scale
  • Failure to complete baseline assessments or behavioral run-in self-monitoring
  • Any other condition judged by Principal Investigator to affect participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Advocate Aurora Research Institute

Milwaukee, Wisconsin, United States, 53204

Actively Recruiting

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Research Team

R

Ramona Donovan, M.S.

CONTACT

T

Teace Markwalter, M.P.H., CHES

CONTACT

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