REAL HEALTH-Diabetes: REach Ahead for Lifestyle and Health-Diabetes

真正的健康-糖尿病：生活方式和健康-糖尿病的进步

• 批准号: 9321161
• 负责人: Linda Michele Delahanty
• 金额: $ 63.31万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-15 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9321161
• 关键词: Adoption; Adult; Affect; American; Behavioral; Blood Pressure; Body Weight; Body Weight decreased; Cardiac; Caring; Community Health Centers; Contracts; Counseling; Data; Diabetes Mellitus; Diet; Dietitian; Dimensions; Disease remission; Dose; Dropout; Eating; Education; Effectiveness; Ensure; Epidemic; Focus Groups; Glycosylated hemoglobin A; Goals; Group Structure; Health; Health behavior; Individual; Insurance Carriers; Intervention; Interview; Length; Life Style; Lipids; Maintenance; Measures; Medical; Medical Nutrition Therapy; Methods; Modeling; Non-Insulin-Dependent Diabetes Mellitus; Nutritional; Obesity; Outcome; Overweight; Participant; Patient Outcomes Assessments; Patients; Persons; Pharmaceutical Preparations; Physical Fitness; Physical activity; Population; Prediabetes syndrome; Primary Health Care; Provider; Quality of life; Randomized Controlled Trials; Research; Resources; Risk Factors; Sample Size; Self Efficacy; Structure; Surveys; Telephone; Testing; Translating; Twin Multiple Birth; United States; Weight; Work; arm; base; behavioral outcome; community setting; comparative effectiveness; compare effectiveness; comparison group; cost; cost effectiveness; design; diabetes prevention program; diet and exercise; follow-up; glycemic control; group intervention; health related quality of life; improved; improved outcome; lifestyle intervention; payment; primary care setting; primary outcome; programs; psychosocial; public health relevance; secondary outcome; skills; standard of care; symposium; three-arm trial; treatment as usual; trial comparing

DESCRIPTION (provided by applicant): The twin epidemics of obesity and diabetes affect most Americans: 70% of US adults are overweight or obese, 26 million have diabetes, and 79 million people have pre-diabetes. While diet and exercise improve outcomes in diabetes, most people with type 2 diabetes eat an unhealthy diet, do little physical activity, and have trouble making and sustaining changes in health behavior. The Look AHEAD trial demonstrated that an intensive lifestyle intervention that teaches skills necessary to make changes in diet and activity led to sustained weight loss, diabetes remission, lower rates of complications, medication reduction, and improved physical fitness and quality of life compared to diabetes support and education. This project will adapt the highly effective but resource-intensive Look AHEAD intensive lifestyle intervention so that it may be delivered with fewer resources in community health center settings, potentially via telephone, greatly expanding its potential reach and impact. Pilot data show feasibility and effectiveness comparable to the Look AHEAD lifestyle intervention: lifestyle group participants lost 6.7% of body weight compared to 2.6% in the individual medical nutrition therapy (MNT) arm (P=0.003) and had twice as much reduction in medications. In this project, we will compare two different implementation strategies for delivery of this group adaptation of the Look AHEAD intensive lifestyle intervention, one using an in-person approach and one using a telephone approach, to dietitian referral for individual medical nutrition therapy in overweight patients with type 2 diabetes. The interventions will take place at three community health centers. Outcomes will be measured at baseline, 6, 12, 24, and 36 months. Aim 1: To evaluate the comparative effectiveness of the adapted Look AHEAD lifestyle change interventions in a three-arm trial comparing random assignment to in-person (IP) group (n=70) and telephone conference call (TCC) group (n=70) implementation strategies to standard of care defined as individual MNT (control; n=70). Medical outcomes will include weight loss (primary), glycemic control, cardiac risk factors, medication dose, and cost. Behavioral outcomes include self-efficacy and health-related quality of life. Aim 2: To evaluate the reach, adoption, implementation fidelity, and maintenance of the adapted Look AHEAD lifestyle change program in in-person and telephone call implementation strategies at the three community health center settings, comparing factors across centers using the RE-AIM Model Dimension items checklist and employing a mixed methods approach including focus groups and structured interviews. Aim 3: To estimate the incremental cost per percentage point decrease in body weight of the implementation strategies assessed in this study compared to usual care. If effective, materials with estimates of approximate implementation costs from this project can be readily disseminated for use in usual care settings throughout the United States.

描述(申请人提供)：肥胖和糖尿病的双重流行病影响着大多数美国人：70%的美国成年人超重或肥胖，2600万人患有糖尿病，7900万人患有糖尿病前期。虽然饮食和锻炼改善了糖尿病患者的预后，但大多数2型糖尿病患者饮食不健康，很少进行体力活动，难以改变和维持健康行为。前瞻试验表明，密集的生活方式干预教授改变饮食和活动所需的技能 与糖尿病支持和教育相比，持续的体重减轻、糖尿病缓解、较低的并发症发生率、用药减少，并改善了身体健康和生活质量。该项目将适应高效但资源密集型的前瞻性密集生活方式干预，以便在社区卫生中心环境中以更少的资源提供，可能通过电话，极大地扩大其潜在的覆盖范围和影响。试点数据显示了与前瞻性生活方式干预相媲美的可行性和有效性：生活方式组的参与者体重下降了6.7%，而个体医疗营养疗法组的参与者体重下降了2.6%(P=0.003)，药物减少的幅度是前者的两倍。在这个项目中，我们将比较两种不同的实施策略，以实现这一群体适应前瞻性强化生活方式干预，一种使用面对面的方法，另一种使用电话的方法，为超重的2型糖尿病患者进行个体化医疗营养治疗的营养师转介。干预措施将在 三个社区卫生中心。将在基线、6个月、12个月、24个月和36个月时测量结果。目的1：在一项三臂试验中，将随机分配给面对面(IP)组(n=70)和电话会议(TCC)组(n=70)的实施策略与定义为个人MNT(对照组；n=70)的护理标准进行比较，以评估适应性前瞻性生活方式改变干预措施的比较有效性。医疗结果将包括体重减轻(主要)、血糖控制、心脏危险因素、用药剂量和费用。行为结果包括自我效能和与健康相关的生活质量。目的2：评估适应的前瞻性生活方式改变计划在三个社区卫生中心的面对面和电话呼叫实施策略的覆盖面、采用率、实施保真度和维持情况，使用RE-AIM模型维度项目检查表比较不同中心的因素，并采用包括焦点小组和结构化访谈在内的混合方法。目的3：评估本研究中评估的实施策略与常规护理相比，体重每下降一个百分点所增加的成本。如果有效，该项目估计的实施成本的材料可以很容易地传播，用于全美各地的日常护理环境。