Status:
ACTIVE_NOT_RECRUITING
Choosing Healthy Activities and Lifestyle Management Through Portal Support
Lead Sponsor:
University of Tennessee
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Weight Loss
Overweight and Obesity
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
The study aims to randomize 250 participants to 1 of 2 arms: a.) an Active Intervention Group (based on the Look AHEAD\* ILI) or b.) a Comparison Group (based on the Look AHEAD DSE Comparison group) t...
Detailed Description
This project tests whether the adapted Look AHEAD Intensive Lifestyle Intervention (ILI) will result in significant weight loss when delivered through Health IT - EHR patient portal compared to a Comp...
Eligibility Criteria
Inclusion
- are ≥ 16 years old
- are overweight or obese (BMI ≥ 25 kg/m2)
- have access to the Internet via the computer or use a cellphone with a data-plan access
- are patients at one of the participating practice sites
- are willing to accept a random assignment, and
- are from different population groups (racial / ethnic minority, lower socioeconomic status, or reside in a rural location).
Exclusion
- coronary or cerebrovascular disease events or vascular procedures within the past 6 months
- certain medical conditions that put participants at high risk of adverse events or preclude exercising
- uncontrolled psychiatric disorders
- current substance abuse, including heavy alcohol use ≥ 5 drinks on the same occasion for ≥ 5 days in the past 30 days
- a history of amputation or bariatric surgery or are planning to have bariatric surgery within the next 12 months
- current weight loss medication use
- malignancy within the last 5 years (except skin cancer)
- plans to move out of the area during the next year
- current participation in another clinical trial
- pregnancy or breast feeding or are planning to become pregnant within the next 12 months, and
- instances judged by the investigators' and primary care providers' discretion.
Key Trial Info
Start Date :
February 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
229 Patients enrolled
Trial Details
Trial ID
NCT05410353
Start Date
February 24 2023
End Date
December 31 2026
Last Update
November 20 2025
Active Locations (1)
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1
University of Tennessee Health Science Center / Department of Preventive Medicine
Memphis, Tennessee, United States, 38105