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.


Introduction: Over one-third of American adults have obesity with increased risk of chronic disease. Primary care providers often do not counsel patients about weight management due to barriers such as lack of time and training. To address this problem, we developed a technology-assisted health coaching intervention called Goals for Eating and Moving (GEM) to facilitate obesity counseling within the patient-centered medical home (PCMH) model of primary care. The objective of this paper is to describe the rationale and design of a cluster-randomized controlled trial to test the GEM intervention when compared to Enhanced Usual Care (EUC).

Method: We have randomized 19 PCMH teams from two NYC healthcare systems (VA New York Harbor Healthcare System and Montefiore Medical Group practices) to either the GEM intervention or EUC. Eligible participants are English and Spanish-speaking primary care patients (ages 18-69 years) with obesity or who are overweight with comorbidity (e.g., arthritis, sleep apnea, hypertension). The GEM intervention consists of a tablet-delivered goal setting tool, a health coaching visit and twelve telephone calls for patients, and provider counseling training. Patients in the EUC arm receive health education materials. The primary outcome is mean weight loss at 1 year. Secondary outcomes include changes in waist circumference, diet, and physical activity. We will also examine the impact of GEM on obesity-related provider counseling competency and attitudes.

Conclusion: If GEM is found to be efficacious, it could provide a structured approach for improving weight management for diverse primary care patient populations with elevated cardiovascular disease risk.

Trial registration: NCT03006328.

Keywords: Behavior change; Diet; Health coach; Lifestyle; Obesity; Physical activity; Primary care; Weight loss.

Publication types

  • Clinical Trial Protocol
  • Research Support, N.I.H., Extramural
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Clinical Protocols
  • Exercise
  • Feeding Behavior
  • Female
  • Humans
  • Male
  • Mentoring / methods*
  • Middle Aged
  • Obesity / therapy*
  • Overweight / therapy
  • Patient Care Planning
  • Primary Health Care / methods
  • Randomized Controlled Trials as Topic
  • Therapy, Computer-Assisted / methods*
  • Weight Reduction Programs / methods*
  • Young Adult

Associated data