Recruiting

Weight Loss Program

Sponsor:

University of Virginia

Code:

NCT07292389

Conditions

Obesity & Overweight

Obesity (Disorder)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Positive Reinforcement

Positive Reinforcement + Areas for Change

Study Details

Brief summary:

The purpose of this research study is to learn how to identify the most effective ways to provide weekly feedback on participants' progress toward intervention goals during a weight loss program.

Conditions

Obesity & Overweight

Obesity (Disorder)

Study ID

NCT07292389

Start date

Mar 23, 2026

Status verified date

Mar, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • 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., an Apple iPhone running iOS 16.4 or higher or Android smartphone running Android 11 or higher) with a cellular and data plan

Exclusion Criteria:

  • Weight greater than 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 greater than or equal to 10 lbs in the 6 months prior to initial pre-screening
  • Physical limitations that prevent walking at a brisk pace for at least 10 minutes 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 confirmation that the potential participant has discussed study participation with their physician if they have been diagnosed with diabetes, hypertension, or has have 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.)
  • Recent (in the past 6 months) changes in medications that affect weight
  • 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 application, wear the physical activity monitor, or use the study e-scale
  • Failure to complete baseline assessment measures
  • Failure to complete at least 4 out of 6 days of self-monitoring dietary and weight self-monitoring during the behavioral run-in period
  • Any other condition(s) which, in the opinion of the Principal Investigator, would adversely affect participation in the study

Study Design

Enrollment

127 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Self Monitoring Feedback

Participants in this study will complete a 60-minute "Weight Loss 101" session and use study-provided tools to record their daily food intake, physical activity, and weight. After a one-week run-in period, they will begin receiving weekly feedback messages. The content and emphasis of these messages will differ between 2 conditions: positive reinforcement vs. positive reinforcement + areas for change.

Interventions

Positive Reinforcement

Feedback composed by a study interventionist that focuses exclusively on positively reinforcing the participant's progress toward achieving their goals.

Positive Reinforcement + Areas for Change

Feedback provided by a study interventionist that combines positive reinforcement of the participant's progress with constructive guidance on areas for improvement to support successful goal attainment.

Primary outcome measure

  • Weight change [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Maddie Glover, B.S.

4342432387ktg7zr@virginia.edu

Teace Markwalter, M.P.H., CHES

540-239-6283bdwcp@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22901

Contacts

Maddie Glover, B.S.

4342432387ktg7zr@virginia.edu

Teace Markwalter, MPH, CHES

540-239-6283bdwcp@virginia.edu

More Information

Sponsor

University of Virginia

Last update posted

Mar 31, 2026

Last verified

Mar, 2026

Keywords

  • weight loss
  • self-monitoring
  • smartphone app
  • lifestyle intervention
  • digital health
  • physical activity
  • dietary change
  • e-scale
  • wearables
  • activity monitor
  • behavior change
  • self-monitor activity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2026-03-31.