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.
Brief Title
The GEM (Goals for Eating and Moving) Study
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Weight Gain
Obesity
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.
* 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.
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
weight gain
weight loss
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
69 Years
Minimum Age
18 Years
NCT Id
NCT03006328
Org Class
Other
Org Full Name
NYU Langone Health
Org Study Id
16-01445
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Technology-Assisted Weight Management Intervention Within Patient-Centered Medical Homes: The GEM (Goals for Eating and Moving) Study
Primary Outcomes
Outcome Measure
Change in Weight From Baseline
Outcome Time Frame
Baseline, Month 12
Outcome Measure
Change in Waist Circumference From Baseline
Outcome Time Frame
Baseline, Month 12
Outcome Measure
Change in Systolic Blood Pressure (SBP) From Baseline
Outcome Time Frame
Baseline, Month 12
Outcome Measure
Change in Diastolic Blood Pressure (DBP) From Baseline
Outcome Time Frame
Baseline, Month 12
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
69
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Judith Wylie-Rosett
Investigator Email
judith.wylie-rosett@einsteinmed.org
Investigator Phone