Back to resultsThe GEM (Goals for Eating and Moving) Study (GEM)
Primary Purpose
Weight Gain, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GEM
Enhanced Usual Care
Sponsored by
About this trial
This is an interventional supportive care trial for Weight Gain focused on measuring weight gain, weight loss
Eligibility 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.
Sites / Locations
- New York University Medical Center Institutional Review Boards
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Participants with Obesity + GEM
Participants with Obesity + Enhanced Usual Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in Weight From Baseline
Change in Waist Circumference From Baseline
Change in Systolic Blood Pressure (SBP) From Baseline
Change in Diastolic Blood Pressure (DBP) From Baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT03006328
First Posted
December 20, 2016
Last Updated
April 6, 2023
Sponsor
NYU Langone Health
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT03006328
Brief Title
The GEM (Goals for Eating and Moving) Study
Acronym
GEM
Official Title
Technology-Assisted Weight Management Intervention Within Patient-Centered Medical Homes: The GEM (Goals for Eating and Moving) Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 20, 2017 (Actual)
Primary Completion Date
May 20, 2020 (Actual)
Study Completion Date
February 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain, Obesity
Keywords
weight gain, weight loss
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
489 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participants with Obesity + GEM
Arm Type
Experimental
Arm Description
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.
Arm Title
Participants with Obesity + Enhanced Usual Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
GEM
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care
Intervention Description
Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed.
Primary Outcome Measure Information:
Title
Change in Weight From Baseline
Time Frame
Baseline, Month 12
Title
Change in Waist Circumference From Baseline
Time Frame
Baseline, Month 12
Title
Change in Systolic Blood Pressure (SBP) From Baseline
Time Frame
Baseline, Month 12
Title
Change in Diastolic Blood Pressure (DBP) From Baseline
Time Frame
Baseline, Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie Jay, MD
Organizational Affiliation
NYU School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University Medical Center Institutional Review Boards
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34856961
Citation
Merriwether EN, Wittleder S, Cho G, Bogan E, Thomas R, Bostwick N, Wang B, Ravenell J, Jay M. Racial and weight discrimination associations with pain intensity and pain interference in an ethnically diverse sample of adults with obesity: a baseline analysis of the clustered randomized-controlled clinical trial the goals for eating and moving (GEM) study. BMC Public Health. 2021 Dec 2;21(1):2201. doi: 10.1186/s12889-021-12199-1.
Results Reference
derived
PubMed Identifier
31229622
Citation
Wittleder S, Ajenikoko A, Bouwman D, Fang Y, McKee MD, Meissner P, Orstad SL, Rehm CD, Sherman SE, Smith S, Sweat V, Velastegui L, Wylie-Rosett J, Jay M. Protocol for a cluster-randomized controlled trial of a technology-assisted health coaching intervention for weight management in primary care: The GEM (goals for eating and moving) study. Contemp Clin Trials. 2019 Aug;83:37-45. doi: 10.1016/j.cct.2019.06.005. Epub 2019 Jun 20.
Results Reference
derived
PubMed Identifier
30766686
Citation
Viglione C, Bouwman D, Rahman N, Fang Y, Beasley JM, Sherman S, Pi-Sunyer X, Wylie-Rosett J, Tenner C, Jay M. A technology-assisted health coaching intervention vs. enhanced usual care for Primary Care-Based Obesity Treatment: a randomized controlled trial. BMC Obes. 2019 Feb 4;6:4. doi: 10.1186/s40608-018-0226-0. eCollection 2019.
Results Reference
derived
Learn more about this trial
The GEM (Goals for Eating and Moving) Study
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