CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 618 enrolled
Drug / intervention
Group-Based Program +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04036006
NCT04036006N/ACompleted

A National Trial of the ELM Lifestyle Program and Remission of the Metabolic Syndrome

Rush University Medical Center·interventional·Posted Jul 29, 2019·Updated Jun 11, 2024

In Brief

A clinical study evaluating Group-Based Program and Self-Directed Program for Metabolic Syndrome. Completed, enrolled 618 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 29, 2019
Enrollment StartJul 1, 2019
Primary CompletionMar 29, 2024
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 6.9 years ago

Interventions

Group-Based Programbehavioral

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.

Self-Directed Programbehavioral

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.