Recruiting

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

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07227051

Conditions

Obesity & Overweight

Obesity (Disorder)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Feedback on Calorie Goal Attainment

Feedback on Dietary Quality

Feedback on Physical Activity Goal Attainment

Goal Setting Prompt

Study Details

Brief summary:

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

Obesity & Overweight

Obesity (Disorder)

Study ID

NCT07227051

Start date

Jan 26, 2026

Status verified date

Jan, 2026

Completion date

Feb 28, 2028

Anticipated

Primary completion date

Feb 28, 2028

Anticipated

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

300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Self Monitoring Feedback

Participants enrolled in the Feedback Optimization trial will be asked to complete a 60-minute Weight Loss 101 session and to track their dietary intake, physical activity, and weight each day using study-provided tools. After the first week of self-monitoring (used as a run-in), participants will be provided with weekly feedback messages. The focus and content of these messages will vary, based on a 2x2x2x2 factorial design.

Interventions

Feedback on Calorie Goal Attainment

Feedback composed by a study interventionist that focuses on the participant's progress toward meeting their caloric intake goal.

Feedback on Dietary Quality

Feedback composed by a study interventionist that provides comments on specific dietary choices that may impact weight loss success.

Feedback on Physical Activity Goal Attainment

Feedback composed by a study interventionist that focuses on the participant's progress toward meeting their physical activity goal.

Goal Setting Prompt

An open-text goal setting prompt, composed by the study interventionist, that encourages the participant to set a behavioral goal for the following week.

Primary outcome measure

Weight change [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Tejashri Ganbote, MBA, MBBS

414-363-1229 Tejashri.ganbote@aah.org

Teace Markwalter, M.P.H., CHES

866-271-7217 bdw9cp@virginia.edu

Locations

Advocate Aurora Research Institute

Recruiting

Milwaukee, Wisconsin, United States, 53204

Contacts

Tejashri Ganbote, MBA, MBBS

414-363-1229 Tejashri.ganbote@aah.org

Principal Investigator:

Kathryn M. Ross, Ph.D., M.P.H.

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jun 24, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-06-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.