Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04302727 · ClinicalTrials.gov registry record · NA
Delicious Eating for Life in Southern Homes
A NA study of Weight Loss and Diet, Healthy, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 360
- Enrollment target
- 1
- Study location
NCT04302727 is a NA study of Weight Loss and Diet, Healthy that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 360 participants, below the 1,498-participant average among 116 other Weight Loss trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04302727, a NA study of Weight Loss and Diet, Healthy, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 360 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,498-participant average among 116 other Weight Loss trials with a reported enrollment target (76% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
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.
NCT04302727 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
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.
What interventions are being tested in trial NCT04302727?
The interventions under investigation include: WW (BEHAVIORAL), Med-South Weight Loss Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT04302727?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Weight Loss
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Metabolic Adaptations to Weight Loss With and Without Exercise
RECRUITING · NA
-
Metabolic Health, Bones and Nuts During Weight Loss in Adults
RECRUITING · NA
-
FAMily-centered WEight Loss for Black Adults (FAM WEL B-ing)
RECRUITING · NA
-
Exercise Effects on Adipose Tissue Structure and Function
RECRUITING · NA
-
Circadian Time Restricted Eating
RECRUITING · NA
-
Family COMIDA (Consumo de Opciones Más Ideales De Alimentos) (Eating More Ideal Food Options)
RECRUITING · NA
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.