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Delicious Eating for Life in Southern Homes
NCT04302727 · View on ClinicalTrials.gov ↗
Study 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 researchers have developed an adapted version of the Mediterranean eating pattern to be more acceptable and realistic for southerners; this adapted version is known as "Med-South." Those who take part in the study will be randomly assigned to either the Med-South weight loss program or WW™. Both programs will last for 2 years with measurement visits at the start of the study and at 4-, 12- and 24-month follow-up. While the primary outcome measured by the trial will be weight loss at 24 months, researchers will collect other data which may show additional health benefits of the Med-South diet. The study team will measure blood markers of inflammation, which are known to improve with better diet quality. Researchers will also measure participants' skin carotenoid levels, which increase with greater fruit and vegetable consumption. The study will be conducted within 2 regional catchment areas (n=360 participants) representing a diverse spectrum of patients and settings. Patients with a BMI ≥ 30 kg/m\^2 will be enrolled and randomized to intervention or augmented usual care. To assure adequate subgroup representation, ≥ 40% of the sample will have diabetes, ≥ 40% will be male, and ≥ 40% will be African American. The intervention will be delivered in 3 phases over 24 months by research staff: Phase I (4 months) focuses on adopting a Med-style dietary pattern; Phase II (8 months) on weight loss; and Phase III (12 months) on weight loss maintenance. Outcomes will be assessed at 4, 12, and 24 months. The primary outcome is weight loss at 24 months. Secondary outcomes include change in physiologic, behavioral, and psychosocial measures. Researchers will also assess implementation cost and the incremental cost-effectiveness of the intervention relative to the augmented usual care group.
Conditions Studied
Interventions
- BEHAVIORAL WW
- BEHAVIORAL Med-South Weight Loss Intervention
Study Locations (1)
North Carolina
- UNC Center for Health Promotion and Disease Prevention — Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2020-07-06 |
| Est. Completion | 2024-06-16 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04302727
The ClinicalTrials.gov registry entry for NCT04302727 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 725 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Weight Loss appearing as the primary indexed condition, and to 2 interventions — of which WW is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04302727 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04302727 about?
NCT04302727 is a clinical study titled "Delicious Eating for Life in Southern Homes". 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 researchers have developed an adapted version of the Mediterranean eating pattern to be more acceptable and re...
What is the current status of trial NCT04302727?
This trial is currently completed. It is a NA study. The enrollment target is 360 participants. The study started on 2020-07-06. Estimated completion is 2024-06-16.
What conditions does trial NCT04302727 study?
This clinical trial studies the following conditions: Weight Loss, Diet, Healthy, Cardiovascular Risk Factor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04302727?
The interventions under investigation include: WW (BEHAVIORAL), Med-South Weight Loss Intervention (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04302727?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 725 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04302727 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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