Status:
COMPLETED
Delicious Eating for Life in Southern Homes
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Weight Loss
Diet, Healthy
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study will compare a new weight loss program that focuses on a healthy eating pattern, with WW™ (formally Weight Watchers), an effective and widely available weight loss program. Study researcher...
Detailed Description
Below, each of the treatment arms is described in detail. Med-South Weight Loss Program Most weight loss programs offer weekly one-on-one or group counseling sessions for 16-20 weeks. The Med-South ...
Eligibility Criteria
Inclusion
- Male or female
- English speaking
- Ages 18-75 (inclusive)
- BMI \> or = 30 kg/m\^2
- Approval for participation by primary care clinician
- Established patient at participating practice defined as at least one prior visit at the practice within the prior 2 years
- Access to telephone
- No plans to move from the area for at least 1 year
- Free living to the extent that participant has control over dietary intake
- Those with known cardiovascular disease will be allowed to participant
Exclusion
- Participant in intensive weight loss program (more than 6 visits) in the prior year
- Another family member or household member is a study participant. Only one member of each household may take part in this study.
- Considering bariatric surgery in the next year or prior bariatric surgery
- Type 1 diabetes. Rationale is patients with type 1 diabetes already received intensive dietary counseling with a focus on total and distribution of daily carbohydrates.
- Pregnancy/breastfeeding or intended pregnancy in the next year
- History of malignancy, other than non-melanoma skin cancer, unless surgically or medically cured \> 5 years ago or in remission. Patients with localized prostate and breast cancer diagnosed during the course of routine screening will not be excluded.
- Advanced kidney disease (estimated creatinine clearance \< 30 mL/min)
- Known drug or alcohol misuse in the past 2 years
- Known psychosis or major psychiatric illness. Those with major depression who have responded to treatment may participate.
Key Trial Info
Start Date :
July 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2024
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT04302727
Start Date
July 6 2020
End Date
June 16 2024
Last Update
November 3 2025
Active Locations (1)
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1
UNC Center for Health Promotion and Disease Prevention
Chapel Hill, North Carolina, United States, 27514