N/A
N=360
Delicious Eating for Life in Southern Homes
Weight Loss · Diet, Healthy · Cardiovascular Risk Factor
Bottom Line
View on ClinicalTrials.gov: NCT04302727 ↗Enrolled (actual)
360
Serious AEs
9.4%
Results posted
Nov 2025
Primary outcome: Primary: Percent Weight Change From Baseline to Month 24 — -4.4; -3.8 percentage weight change — p=0.43
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Med-South Weight Loss Intervention (Behavioral); WW (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Weight Change From Baseline to Month 24 |
-4.4; -3.8 | 0.43 |
| SECONDARY Percent Weight Change From Baseline to Months 4 and 12 |
-0.9; -4.4; -4.6; -4.3 | <0.0001 sig |
| SECONDARY Percentage Weight From Baseline Through Follow-Up by Sub-Groups |
-1.7; -3.7; -0.6; -4.7; -0.3; -4.0 | 0.02 sig |
| SECONDARY Mean Weight Change From Baseline Through Follow-Up |
-1.1; -4.8; -5.1; -4.6; -5.1; -4.1 | <0.001 sig |
| SECONDARY Mean Change in Systolic Blood Pressure From Baseline Through Follow-Up |
-4.1; -4.5; -6.5; -5.2; -4.7; -3.9 | 0.77 |
| SECONDARY Mean Change in Diastolic Blood Pressure From Baseline Through Follow-Up |
-3.4; -3.3; -4.6; -3.9; -3.2; -3.2 | 0.91 |
| SECONDARY Mean Change in Total Cholesterol From Baseline Through Follow-Up |
-1.4; -4.3; -5.1; -3.6; -2.6; -10.2 | 0.29 |
| SECONDARY Mean Change in HDL-Cholesterol From Baseline Through Follow-Up |
-0.1; -0.1; 1.7; 1.4; 3.0; 2.9 | 0.96 |
| SECONDARY Mean Change in Triglycerides From Baseline Through Follow-Up |
-6.1; -9.4; -8.6; -5.8; -10.4; -4.2 | 0.55 |
| SECONDARY Mean Change LDL-cholesterol From Baseline Through Follow-up |
-1.7; -2.6; -5.59; -4.97; -5.87; -13.90 | 0.99 |
| SECONDARY Mean Change in A1c From Baseline Through Follow-Up |
0.0; -0.2; -0.1; -0.2; 0.0; -0.2 | 0.05 |
| SECONDARY Mean Change in CRP (C-Reactive Protein) From Baseline Through Follow-Up |
0.1; -0.6; 1.0; 0.4; -0.7; -1.1 | 0.10 |
| SECONDARY Mean Change in Interleukin (IL) IL-6 From Baseline Through Follow-Up |
-0.63; -0.35; -0.64; -0.14; -0.20; -1.60 | 0.96 |
| SECONDARY Mean Change in Tumor Necrosis Factor (TNF) TNF-alpha From Baseline Through Follow-Up |
-0.39; -0.03; -0.69; -0.30; -1.27; -0.16 | 0.82 |
| SECONDARY Mean Change in Skin Carotenoids From Baseline Through Follow-Up |
8.5; 31.8; 24.3; 30.8; 13.5; 12.6 | 0.0007 sig |
| SECONDARY Mean Change in Quality of Life Scale From Baseline Through Follow-Up |
0.009; 0.012; 0.005; 0.012; -0.009; 0.000 | 0.83 |
| SECONDARY Mean Change in Alternate Healthy Eating Index (AHEI)-2010 From Baseline Through Follow-Up |
8.2; 2.8; 8.8; 2.4; 6.6; 3.0 | <0.0001 sig |
| SECONDARY Mean Change in Global Physical Activity Questionnaire (GPAQ) From Baseline Through Follow-Up |
0.92; 1.00; 1.67; 1.00; 0.17; 0.90 | 0.92 |
| SECONDARY Mean Change in Weight Loss Self-Efficacy From Baseline Through Follow-Up |
2.9; 1.60; 5.0; 0.4; 5.3; 2.8 | 0.44 |
| SECONDARY Mean Change in Dietary Self-Regulation From Baseline Through Follow-Up |
0.1; 0.0; 0.2; -0.1; 0.1; -0.3 | 0.32 |
| SECONDARY Mean Change in Eating Attitudes From Baseline Through Follow-Up (Cognitive Restraint) |
1.7; 2.3; 2.5; 1.6; 2.3; 1.8 | 0.10 |
| SECONDARY Mean Change in Eating Attitudes From Baseline Through Follow-Up (Uncontrolled Eating) |
-1.2; -0.5; -2.0; -0.8; -1.9; -0.1 | 0.10 |
| SECONDARY Mean Change in Eating Attitudes From Baseline Through Follow-Up (Emotional Eating) |
-0.4; -0.6; -0.6; -0.3; -0.6; -0.5 | 0.41 |
| SECONDARY Mean Change in Diet Self-Efficacy From Baseline Through Follow-Up |
0.5; -0.1; 0.5; -0.4; -0.1; -0.8 | 0.13 |
| SECONDARY Mean Change in Self-Weighing Behaviors From Baseline Through Follow-Up |
1.1; 0.6; 1.7; 0.5; 1.5; 0.3 | 0.002 sig |
| SECONDARY Economic Outcome--Incremental Cost-Effectiveness |
NA; NA | — |
| SECONDARY Economic Outcome--Incremental Cost Per Quality Adjusted Life Year (QALY) Gained |
NA; NA | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04302727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.