Enhanced Lifestyles for Metabolic Syndrome

Summary

This is a multi-center behavioral randomized trial with the aim of comparing a group-based lifestyle intervention with a self-directed lifestyle intervention on remission of the metabolic syndrome over 2 years of follow-up.

Conditions

• Metabolic Syndrome

Interventions

BEHAVIORAL

Group-Based Program

The Group-based Program uses an ecologically valid setting in which participants exercise, prepare foods, and eat together to facilitate the emergence of old habits and replace them with healthy alternatives. The intervention team consists of a health psychologist, registered dietitian, and health coach. They co-facilitate group meetings for 15 participants that are held weekly for 3 months, bi-weekly for 3 months, and then monthly in participant-led maintenance meetings. Each session includes: weigh-in and physical activity (20 min), cooking demonstration (20 min), and a shared vegetable dish with discussion (50 min). The maintenance phase (months 7 to 24 post randomization) consists of support and health-related topics of the participants' own choosing. Progress reports with lab results are sent to participants and primary care physicians.

BEHAVIORAL

Self-Directed Program

The Self-Directed lifestyle program represents enhanced usual care based upon what is currently offered in primary care in the United States for lifestyle treatments for adults with metabolic syndrome. Usual care is enhanced by: 1) lifestyle education for management of metabolic syndrome provided in evidence-based tip sheets from nationally recognized organizations; 2) provision of a Fitbit for self-monitoring physical activity; 3) access to a website containing all education materials; and 4) progress report letters with lab results sent to participants and primary care physicians after completion of each assessment.

Sponsors & Collaborators

• University of Colorado, Denver

  collaborator OTHER

• Geisinger Clinic

  collaborator OTHER

• Rochester Institute of Technology

  collaborator OTHER

• University of Missouri, Kansas City

  collaborator OTHER

• Rush University Medical Center

  lead OTHER

Principal Investigators

• Lynda Powell, PhD · Rush University Medical Center

• Sumihiro Suzuki, PhD · Rush University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-07-01

Primary Completion

2024-03-29

Completion

2024-03-29

Countries

• United States

Study Locations