The GEM (Goals for Eating and Moving) Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Weight Gain, Obesity

Intervention / Treatment
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* Behavioral: GEM
* Behavioral: Enhanced Usual Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants with Obesity + GEM<br>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<br>* 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.<br>|
| Active Comparator: Participants with Obesity + Enhanced Usual Care<br>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<br>* Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight gain, weight loss