Clinical trial NCT03006328: The GEM (Goals for Eating and Moving) Study
Official title: Technology-Assisted Weight Management Intervention Within Patient-Centered Medical Homes: The GEM (Goals for Eating and Moving) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Gain
Obesity
Keywords: weight gain
weight loss
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-12-30
Enrollment: 489
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in Weight From Baseline
timeFrame: Baseline, Month 12
measure: Change in Waist Circumference From Baseline
timeFrame: Baseline, Month 12
measure: Change in Systolic Blood Pressure (SBP) From Baseline
timeFrame: Baseline, Month 12
measure: Change in Diastolic Blood Pressure (DBP) From Baseline
timeFrame: Baseline, Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Medical Center Institutional Review Boards
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Melanie Jay, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.