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
- PMID: 24416670
- PMCID: PMC3833533
- DOI: 10.7453/gahmj.2013.035
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
Abstract
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.
背景: 2 型糖尿病 (T2D) 及冠心 病 (CHD) 是军人普遍不能幸免的 慢性疾病。虽然已经确定这些疾 病的许多遗传标记,但尚未确立 对这些多因性疾病进行遗传风险 检测的临床应用。同时,尚未探 索进行行为干预(如在 T2D 或 CHD 风险咨询干预之后进行健康辅 导)的必要。我们在此提出对现 役美国空军 (AF) 退休人员和受益 者的遗传风险检测和健康辅导的 临床应用进行评估的理论依据、 设计和方案。主要研究目标:将健康辅导和提 供遗传风险信息加入 CHD 和 T2D 健康行为和临床风险标记的标准 风险咨询中,确定其直接和相互 影响。设计: 4 组(2 X 2 阶乘)随机 对照试验。环境: 美国西海岸的两处 AF 基 础护理临床设施。参与者:成年 AF 基础护理患者。干预: 所有参加者将到临床提供 者处进行风险咨询就诊,讨论个 人 T2D 和 CHD 的风险因素。一半 的参与者(两组)也将在风险咨 询期间得知其 T2D 和 CHD 的遗传 风险测试结果。随机分配至接受 健康辅导两组的参与者随后将接 受逾 6 个月的电话健康辅导。主要结果测量指标: 行为测量指 标(自我报告的饮食摄入、体力 活动、戒烟、药物依从性);临 床结果(AF 综合健身分数、体 重、腰围、血压、空腹血糖、血 脂、T2D/CHD 风险分数)以及心理 测量指标(自我效能、忧虑、感 知风险)将于基线期及 6 周、3 、6 和 12 个月内收集。结论: 本研究对部署在现有 AF 基础护理中的新策略进行测试, 通过患者参与和自我管理支持的 方法,加强坚持有据
Fundamentación: La diabetes de tipo 2 (DT2) y las cardiopatías coronarias (CC) constituyen enfermedades crónicas muy extendidas de las cuales no está exento el personal militar. Aunque se han encontrado numerosos marcadores genéticos para estas enfermedades, aún se desconoce la utilidad clínica de las pruebas de riesgo genético para enfermedades multifactoriales como estas. Tampoco se ha explorado la necesidad de una intervención conductual como la formación sanitaria tras una intervención de asesoramiento sobre el riesgo de DT2 o CC. Aquí presentamos la justificación, el diseño y el protocolo para evaluar la utilidad clínica de las pruebas de riesgo genético y la formación sanitaria de miembros en activo, jubilados y beneficiarios de las fuerzas aéreas (FF. AA.) estadounidenses.
Objetivos principales del estudio: Conocer los efectos directos e interactivos de la formación sanitaria y proporcionar información sobre el riesgo genético, cuando se combina con el asesoramiento estándar acerca del riesgo de CC y de DT2, sobre las conductas relacionadas con la salud y los marcadores de riesgo clínico.
Diseño: Ensayo controlado y aleatorizado con cuatro grupos (factorial de 2 x 2).
Entorno: Dos entornos clínicos de atención primaria de las FF. AA. situados en la costa oeste de Estados Unidos.
Participantes: Pacientes adultos de atención primaria de las FF. AA.
Intervención: Todos los participantes acudirán a una visita de asesoramiento sobre riesgos con un profesional sanitario para hablar de los factores personales de riesgo de DT2 y CC. La mitad de los participantes (dos grupos) conocerá también los resultados de sus pruebas de riesgo genético de DT2 y de CC en esta sesión de asesoramiento sobre riesgos. Los participantes asignados aleatoriamente a los dos grupos, que reciban formación sanitaria, recibirán formación sanitaria telefónica a lo largo de 6 meses.
Criterios de valoración principales: En el inicio, la sexta semana y al cabo de 3, 6 y 12 meses se obtendrán mediciones conductuales (ingesta dietética declarada, actividad física, abandono del tabaco, cumplimiento del tratamiento farmacológico), resultados clínicos (puntuaciones combinadas de la condición física de las FF. AA., peso, perímetro de cintura, presión arterial, glucosa en ayunas, lípidos, puntuaciones de riesgo de DT2 y CC) y mediciones psicosociales (autoeficacia, preocupación, riesgo percibido).
Conclusiones: En este estudio, se examinan algunas estrategias nuevas adoptadas dentro de la atención primaria existente de las FF. AA. para mejorar el cumplimiento de la dieta basada en evidencias, la actividad física, el abandono del tabaco y la medicación para reducir el riesgo de DT2 y CC, a través de métodos de compromiso de los pacientes y de apoyo de la autogestión.
Keywords: Health coaching; behavior change; chronic disease; coronary heart disease; diabetes; genomics.
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