Status:
COMPLETED
Support and Tracking to Achieve Results (Project STAR)
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The investigators propose to conduct a randomized controlled trial assessing the impact of phone-based extended care delivered on an ADAPTIVE (when participants are at "high risk" for weight regain as...
Detailed Description
Obesity remains a substantial public health challenge in the United States. While behavioral lifestyle interventions have been demonstrated to produce weight losses of 8-10% in adults with overweight ...
Eligibility Criteria
Inclusion
- BMI 30.0-45.0 kg/m2
- Own a smartphone \[Apple iPhone (5s or newer) or Android smartphone (KitKat OS 4.4 or newer)\] with a cellular and data plan
- Weight ≤ 396 pounds (due to scale limit)
- Lose ≥ 5% of baseline weight during the initial weight loss intervention (Month 0 to Month 4)
- Completion of baseline assessment measures
Exclusion
- History of bariatric surgery
- Current use of weight loss medications
- Weight loss of ≥ 10 lb in prior 6 months
- Physical limitations that prevent walking ¼ mile without stopping
- Use of a pacemaker
- 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 type 2 diabetes, hypertension, or has a history of coronary heart disease
- More than one participant per 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, or plans to relocate during the study period)
Key Trial Info
Start Date :
October 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 5 2024
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT04116853
Start Date
October 17 2019
End Date
November 5 2024
Last Update
November 5 2025
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610