Health coaching and genomics-potential avenues to elicit behavior change in those at risk for chronic disease: protocol for personalized medicine effectiveness study in air force primary care.

Background: Type 2 diabetes (T2D) and coronary heart disease (CHD) are prevalent chronic diseases from which military personnel are not exempt. While many genetic markers for these diseases have been identified, the clinical utility of genetic risk testing for multifactorial diseases such as these has not been established. The need for a behavioral intervention such as health coaching following a risk counseling intervention for T2D or CHD also has not been explored. Here we present the rationale, design, and protocol for evaluating the clinical utility of genetic risk testing and health coaching for active duty US Air Force (AF) retirees and beneficiaries.

Primary Study Objectives: Determine the direct and interactive effects of health coaching and providing genetic risk information when added to standard risk counseling for CHD and T2D on health behaviors and clinical risk markers.

Design: Four-group (2 X 2 factorial) randomized controlled trial.

Setting: Two AF primary care clinical settings on the west coast of the United States.

Participants: Adult AF primary care patients.

Intervention: All participants will have a risk counseling visit with a clinic provider to discuss personal risk factors for T2D and CHD. Half of the participants (two groups) will also learn of their genetic risk testing results for T2D and CHD in this risk counseling session. Participants randomized to the two groups receiving health coaching will then receive telephonic health coaching over 6 months.

Main Outcome Measures: Behavioral measures (self-reported dietary intake, physical activity, smoking cessation, medication adherence); clinical outcomes (AF composite fitness scores, weight, waist circumference, blood pressure, fasting glucose, lipids, T2D/CHD risk scores) and psychosocial measures (self-efficacy, worry, perceived risk) will be collected at baseline and 6 weeks, and 3, 6, and 12 months.

Conclusion: This study tests novel strategies deployed within existing AF primary care to increase adherence to evidence-based diet, physical activity, smoking cessation, and medication recommendations for CHD and T2D risk reduction through methods of patient engagement and self-management support.