# Randomized Explanatory Trial of a Mediterranean Dietary Pattern Weight Loss Intervention for Primary Care Practices

> **NIH NIH R33** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2020 · $749,411

## Abstract

ABSTRACT
 The obesity epidemic in the US continues nearly unabated, with increasingly alarming statistics regarding
the parallel rise in other chronic diseases and the resulting increase in healthcare costs. The United States
Preventive Services Task Force (USPSTF) recommends that primary care patients be screened for obesity
and that those with a body mass index (BMI) ≥30 kg/m2 receive an intensive, multicomponent behavioral
weight loss intervention. However, the effectiveness of weight loss interventions implemented in primary care
settings has been limited, with a recent meta-analysis showing only modest weight loss (1.2 kg) after 2 years.
In addition, previously studied weight loss interventions in the US have largely failed to improve
cardiovascular disease (CVD) event rates or total mortality.
 A growing body of evidence points to the health benefits of the Mediterranean (Med) diet, with strong
observational and clinical trial data supporting the health benefits of this dietary pattern that includes generous
consumption of high-quality fats and carbohydrates. Positive health outcomes include reduced CVD events
and recent data suggests benefits for cancer prevention, cognitive health, and all-cause mortality. Many have
raised the question whether a Med-style diet can be followed in the US (be acceptable to the American palate),
particularly among low-income and minority populations who experience disproportionally high rates of CVD.
 Our research team has adapted a Med-style diet to the cultural preferences of the Southeast (“Med-South
diet”) and this dietary pattern has achieved high levels of acceptability in low-income, primarily minority
populations. In a large pre-post study evaluating the Med-South dietary intervention, we saw significant weight
loss (3.6% of initial weight at 2 years) among participants with diabetes. What is missing is an explanatory
(efficacy) randomized trial testing whether a primary care-based weight loss intervention emphasizing a
healthful eating pattern (Med-South) can yield long-term weight loss and improved CVD risk profiles.
 Thus, we propose a randomized trial to assess a clinic-based, weight loss intervention promoting a Med-
style dietary pattern. It will be conducted at 5 primary care sites (n=350 participants) representing a diverse
spectrum of patients and settings. Patients with a BMI ≥ 30 kg/m2 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, an...

## Key facts

- **NIH application ID:** 10026331
- **Project number:** 4R33HL142680-02
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** THOMAS C KEYSERLING
- **Activity code:** R33 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $749,411
- **Award type:** 4N
- **Project period:** 2019-06-01 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10026331

## Citation

> US National Institutes of Health, RePORTER application 10026331, Randomized Explanatory Trial of a Mediterranean Dietary Pattern Weight Loss Intervention for Primary Care Practices (4R33HL142680-02). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10026331. Licensed CC0.

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