Delicious Eating for Life in Southern Homes

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

• Weight Loss
• Diet, Healthy
• Cardiovascular Risk Factor

Interventions

BEHAVIORAL

Med-South Weight Loss Intervention

Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.

BEHAVIORAL

WW

If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Carmen D Samuel-Hodge, PhD · University of North Carolina, Chapel Hill

• Thomas C Keyserling, MD · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-07-06

Primary Completion

2024-06-16

Completion

2024-06-16

Countries

• United States

Study Locations