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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

Tracking Information
First Submitted Date  ICMJE December 20, 2016
First Posted Date  ICMJE December 30, 2016
Last Update Posted Date March 13, 2020
Actual Study Start Date  ICMJE November 20, 2017
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2016)
  • Mean Weight Loss using Mann Whitney tests [ Time Frame: 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. [ Time Frame: 12 months ]
    Will be used to test whether or not patients achieve ≥5% weight loss.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The GEM (Goals for Eating and Moving) Study
Official Title  ICMJE Technology-Assisted Weight Management Intervention Within Patient-Centered Medical Homes: The GEM (Goals for Eating and Moving) Study
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Weight Gain
  • Obesity
Intervention  ICMJE
  • Behavioral: GEM
    GEM tool +Health Coaching
  • 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.
Study Arms  ICMJE
  • Experimental: Obese Subjects + GEM
    Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity
    Intervention: Behavioral: GEM
  • 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
    Intervention: Behavioral: Enhanced Usual Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 24, 2019)
512
Original Estimated Enrollment  ICMJE
 (submitted: December 27, 2016)
384
Estimated Study Completion Date  ICMJE August 31, 2021
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sandra Wittleder, PhD 212-263-4149 sandra.wittleder@nyulangone.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03006328
Other Study ID Numbers  ICMJE 16-01445
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Melanie Jay, MD NYU School of Medicine
PRS Account NYU Langone Health
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP