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Completed

NCT Number: NCT03006328

The GEM (Goals for Eating and Moving) Study

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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Key information

Conditions

Weight Gain Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University Medical Center Institutional Review Boards

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GEM

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.

Enhanced Usual Care

Behavioral

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

Primary outcomes

  1. Change in Weight From Baseline

    Time frame: Baseline, Month 12

  2. Change in Waist Circumference From Baseline

    Time frame: Baseline, Month 12

  3. Change in Systolic Blood Pressure (SBP) From Baseline

    Time frame: Baseline, Month 12

  4. Change in Diastolic Blood Pressure (DBP) From Baseline

    Time frame: Baseline, Month 12

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Acronym: GEM

Important dates

Study start
2017
Primary completion
2020
Study completion
2022
First posted
Dec 30, 2016
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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