The GEM (Goals for Eating and Moving) Study

Sponsor

NYU Langone Health (Other)

Overall Status

Completed

CT.gov ID

NCT03006328

Collaborator

(none)

545

Enrollment

Location

Arms

51.1

Actual Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Weight Gain Obesity	Behavioral: GEM Behavioral: Enhanced Usual Care	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

545 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Nov 20, 2017

Actual Primary Completion Date :

May 20, 2020

Actual Study Completion Date :

Feb 22, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Obese Subjects + GEM Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity	Behavioral: GEM GEM tool +Health Coaching
Active Comparator: Obese Subjects + Enhanced Usual Care Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity	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.

Arm

Intervention/Treatment

Experimental: Obese Subjects + GEM

Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity

Behavioral: GEM

GEM tool +Health Coaching

Active Comparator: Obese Subjects + Enhanced Usual Care

Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity

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.

Outcome Measures

Primary Outcome Measures

Mean Weight Loss using Mann Whitney tests [12 months]
Mann-Whitney tests for continuous outcomes (e.g., weight loss)
Fisher's exact tests for categorical outcomes will be used to compare the two intervention arms at 12 months. [12 months]
Will be used to test whether or not patients achieve ≥5% weight loss.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University Medical Center Institutional Review Boards	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT03006328

Other Study ID Numbers:

16-01445

First Posted:

Dec 30, 2016

Last Update Posted:

Aug 10, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by NYU Langone Health

weight gain

weight loss

Additional relevant MeSH terms:

Weight Gain

Study Results

No Results Posted as of Aug 10, 2022