The GEM (Goals for Eating and Moving) Study (GEM)

April 6, 2023 updated by: NYU Langone Health

Technology-Assisted Weight Management Intervention Within Patient-Centered Medical Homes: The GEM (Goals for Eating and Moving) Study

The GEM intervention leverages the patient-centered medical home model by using the GEM tool to provide individually tailored, patient-centered care, promote standardized weight management counseling by health coaches and primary team members, coordinate care between teams and other weight management service providers/programs (e.g., dietitians, health educators, DPP), and provide feedback to the provider and primary care team about patients' weight management-related goals, progress, and care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To establish the efficacy of the GEM intervention, investigators will conduct a cluster randomized controlled 12-month intervention of 19 primary care teams at two urban healthcare systems with Medical Home models of care to compare the GEM intervention (intervention arm) with Enhanced Usual Care (educational materials; control arm).

The specific aims of this study are:

  • Test the impact of the GEM intervention on weight change, and clinical and behavioral outcomes.
  • Identify predictors of weight loss in the GEM intervention arm related to: a) goal-setting processes and b) intervention components
  • Determine the impact of the GEM intervention on obesity-related counseling practices and attitudes in primary care providers.

Study Type

Interventional

Enrollment (Actual)

489

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University Medical Center Institutional Review Boards

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Between the ages of 18-69 years of age,
  • Body mass index of ≥30kg/m2 OR
  • Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity
  • Hypertension
  • High Cholesterol
  • Sleep Apnea
  • Osteoarthritis
  • Metabolic Syndrome
  • Prediabetes
  • Under primary care team care with at least one prior visit with their provider in the past 24 months
  • Access to a telephone, and ability to travel for in-person evaluations at baseline, 6, 12, and 24 months

Exclusion Criteria:

  • Patients who do not speak English or Spanish,
  • Have active psychosis or other cognitive issues,
  • Psychoactive substance use
  • Diabetes
  • Taking prescription weight-loss medication
  • Health condition that may prohibit the patient from walking or physical activity such as chest tightness, a heart condition, or severe arthritis
  • Participated in MOVE!, DPP, or another intensive weight management program (>3 sessions) in the past year,
  • Have a history of bariatric surgery,
  • Are pregnant, or become pregnant during the intervention period,
  • Metastatic cancer in the last 6 months, current chemotherapy or cancer treatment,
  • Have a provider who states they should not participate,
  • Patients who do not want to lose weight
  • Have self-reported inability to read at 5th grade level.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants with Obesity + GEM
Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will be assigned to GEM Tool and a health coach.
Behavioral: GEM
Online program designed to support health coach and primary care team counseling. It assesses current behaviors, barriers, and facilitators to weight loss via a 16-item questionnaire, provides tailored advice, and guides patients to set weight loss (5-10%), diet, and physical activity (PA) goals. After completing the tool, participants will meet with a Health Coach. Participants will receive 12 telephone coaching calls by a health coach over 12 months.
Active Comparator: Participants with Obesity + Enhanced Usual Care
Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will receive receive non-tailored weight management handouts by health coaches.
Behavioral: Enhanced Usual Care
Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Weight From Baseline
Time Frame: Baseline, Month 12
Baseline, Month 12
Change in Waist Circumference From Baseline
Time Frame: Baseline, Month 12
Baseline, Month 12
Change in Systolic Blood Pressure (SBP) From Baseline
Time Frame: Baseline, Month 12
Baseline, Month 12
Change in Diastolic Blood Pressure (DBP) From Baseline
Time Frame: Baseline, Month 12
Baseline, Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Melanie Jay, MD, NYU School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2017

Primary Completion (Actual)

May 20, 2020

Study Completion (Actual)

February 22, 2022

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

December 27, 2016

First Posted (Estimate)

December 30, 2016

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-01445

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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