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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03006328
Recruitment Status : Recruiting
First Posted : December 30, 2016
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 512 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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 : November 20, 2017
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Mean Weight Loss using Mann Whitney tests [ Time Frame: 12 months ]
    Mann-Whitney tests for continuous outcomes (e.g., weight loss)

  2. Fisher's exact tests for categorical outcomes will be used to compare the two intervention arms at 12 months. [ Time Frame: 12 months ]
    Will be used to test whether or not patients achieve ≥5% weight loss.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03006328


Contacts
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Contact: Sandra Wittleder, PhD 212-263-4149 sandra.wittleder@nyulangone.org

Locations
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United States, New York
New York University Medical Center Institutional Review Boards Recruiting
New York, New York, United States, 10016
Contact: Sandra Wittleder, PhD    212-263-4149    sandra.wittleder@nyulangone.org   
Principal Investigator: Melanie Jay, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Melanie Jay, MD NYU School of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03006328    
Other Study ID Numbers: 16-01445
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
weight gain
weight loss
Additional relevant MeSH terms:
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Weight Gain
Body Weight
Body Weight Changes