Status:
COMPLETED
Optimizing Self-Monitoring Feedback for the Treatment of Obesity
Lead Sponsor:
University of Florida
Conditions:
Obesity
Weight Loss
Eligibility:
All Genders
18+ years
Phase:
NA
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 sel...
Detailed Description
Self-monitoring (e.g., of weight, dietary intake, and physical activity) is a core component in evidence-based comprehensive lifestyle interventions for obesity, and greater adherence to self-monitori...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.)
- 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 applications, wear the physical activity monitor, or use the study e-scale
- Failure to complete baseline assessment measures
- Failure to complete at least 5 out of 7 days of self-monitoring dietary and weight self-monitoring during the behavioral run-in period
- Other conditions which in the opinion of the Principal Investigator would adversely affect participation in the study
Key Trial Info
Start Date :
July 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06508580
Start Date
July 23 2024
End Date
February 3 2025
Last Update
April 8 2025
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610