The GEM (Goals for Eating and Moving) Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

489 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-20

Study Completion Date

2022-02-22

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.

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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.

Conditions

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Weight Gain Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Participants with Obesity + GEM

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.

Group Type EXPERIMENTAL

GEM

Intervention Type BEHAVIORAL

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.

Participants with Obesity + Enhanced Usual Care

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.

Group Type ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type BEHAVIORAL

Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed.

Interventions

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GEM

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

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.

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No