Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics

针对糖尿病前期患者的多渠道自动化饮食和身体活动干预

• 批准号: 8508388
• 负责人: GLADYS BLOCK
• 金额: $ 58.11万
• 依托单位: BERKELEY ANALYTICS, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8508388
• 关键词: Adult; Advisory Committees; Affect; Algorithms; Behavior; Behavioral; Body Weight Changes; Body Weight decreased; Centers for Disease Control and Prevention (U.S.); Client; Clinic Visits; Complement; Control Groups; Counseling; Data; Databases; Diabetes Mellitus; Diet; Effectiveness; Electronic Mail; Elements; Expenditure; Feedback; Focus Groups; Future; Glucose; Goals; Grant; Health behavior; Internet; Intervention; Life Style; Measures; Medical Care Costs; Methods; Modification; Non-Insulin-Dependent Diabetes Mellitus; Nurse Practitioners; Participant; Patients; Persons; Phase; Phase III Clinical Trials; Physical activity; Physicians; Prediabetes syndrome; Prevention program; Printing; Process; Randomized; Randomized Controlled Trials; Recommendation; Recruitment Activity; Reporting; Research; Research Personnel; Sampling; Services; Small Business Innovation Research Grant; Social Network; Solutions; Telephone; Testing; Time; Weight; Weight Gain; Weight maintenance regimen; Weights and Measures; Wellness Program; base; behavior change; cardiovascular disorder risk; commercialization; compare effectiveness; computerized; cost; cost effectiveness; diabetes education; diabetes prevention program; diabetic; effective intervention; glycemic control; improved; lifestyle intervention; member; preclinical study; prevent; programs; randomized trial; reinforcer; standard care; standard of care; tool; treatment as usual

DESCRIPTION (provided by applicant): Significance: Almost 30% of U.S. adults have pre-diabetes. Without weight loss and changes in physical activity and diet, more than 50% of them will eventually develop type 2 diabetes (T2DM), with its increased risk of cardiovascular disease and many other complications. The Diabetes Prevention Program (DPP) proved that lifestyle changes involving weight loss, increased physical activity and dietary changes can delay or prevent the onset of T2DM in pre-diabetics. However, intensive interventions like DPP are expensive (DPP: $1,399/person) and demanding of both patient and professional time. As a result, despite the critical need to prevent progression to T2DM, prevention programs have not been embodied in effective, low-cost, real-world interventions that can assist millions of pre-diabetics. Objectives: The overall goal of this fast-track proposal is to produce a commercializable product aimed at changing physical activity, diet and weight loss behaviors of pre-diabetics. The specific aims are to 1) Adapt an existing successful email/Internet wellness program to focus on prediabetics; 2) Conduct a randomized trial of effectiveness in changing weight, glucose and physical activity in pre-diabetics; 3) Provide data on cost and participation, for commercialization and future phase 3 trials. Methods: "Alive" is an email-delivered intervention to improve physical activity and diet, developed through an R01 to Kaiser Permanente. In a randomized controlled trial, Alive significantly improved all of its target behaviors. The latest version, through an SBIR grant, has added automated tailored print and phone counseling, social networking and a substantial emphasis on weight control. Alive will now be modified to focus on pre-diabetes and the behaviors required for its effective control. The modified program will be delivered over I year through 3 channels (email/internet, phone, print), and will use computerized algorithms to deliver highly individualized weekly goal-setting and motivational support. In the clinical trial, pre-diabetics will be identified through the Kaiser Permanente member database. At clinic visits at baseline, 3 and 12 months, weight and measures of glycemic control will be obtained. Subjects will be randomly assigned to the modified program, Alive-PD, or a control condition representing usual care of pre-diabetics. There is statistical power to detect a clinically meaningful difference between the two groups in weight loss and glycemic control (A1c). Effectiveness, proportion reached, participation and cost will be reported. Impact: A low-cost program such as this could reach thousands or millions of prediabetics with a behavior- change intervention, at a fraction of the cost of in-person or group approaches. If proven effective at improving weight loss and glycemic control in a randomized trial, it could become an important component of the standard of care for prediabetics as a stand-alone service, as a complement to pre-diabetes education classes, and as an important reinforcer of physician and nurse practitioner recommendations.

说明（由申请人提供）：意义：近30%的美国成年人患有糖尿病前期。如果不减轻体重，不改变身体活动和饮食，其中50%以上的人最终会患上2型糖尿病（T2DM），心血管疾病和许多其他并发症的风险会增加。糖尿病预防计划（DPP）证明，生活方式的改变，包括减肥、增加体育活动和饮食的改变，可以延缓或预防糖尿病前期2型糖尿病的发生。然而，像DPP这样的强化干预是昂贵的（DPP: 1399美元/人），并且需要病人和专业人员的时间。因此，尽管迫切需要预防进展为2型糖尿病，但预防方案尚未体现为有效的、低成本的、能够帮助数百万糖尿病前期患者的实际干预措施。目标：该快速通道提案的总体目标是生产一种可商业化的产品，旨在改变糖尿病前期患者的身体活动、饮食和减肥行为。具体目标是：1)调整现有的成功的电子邮件/互联网健康计划，重点关注糖尿病前期患者；2)对糖尿病前期患者进行随机试验，观察其改变体重、血糖和体力活动的有效性；3)提供成本和参与数据，用于商业化和未来的3期试验。方法：“活着”是一种通过电子邮件发送的干预措施，旨在改善身体活动和饮食，通过对Kaiser Permanente的R01开发。在一项随机对照试验中，Alive显著改善了其所有目标行为。最新的版本，通过SBIR的拨款，增加了自动定制的印刷和电话咨询，社交网络和大量强调体重控制。Alive现在将被修改为专注于糖尿病前期和有效控制糖尿病所需的行为。修改后的计划将通过3种渠道（电子邮件/互联网，电话，印刷品）在一年内交付，并将使用计算机化算法提供高度个性化的每周目标设定和激励支持。在临床试验中，将通过Kaiser Permanente会员数据库确定糖尿病前期患者。在基线、3个月和12个月的临床访问中，将获得体重和血糖控制措施。受试者将被随机分配到修改后的方案，Alive-PD，或代表糖尿病前期患者常规护理的对照条件。两组在减重和血糖控制（糖化血红蛋白）方面存在有临床意义的差异。将报告有效性、达到的比例、参与和成本。影响：像这样的低成本项目可以让成千上万的前驱糖尿病患者接受行为改变干预，而成本只是面对面或团体治疗的一小部分。如果在一项随机试验中被证明有效地改善了体重减轻和血糖控制，它可能成为糖尿病前期患者护理标准的重要组成部分，作为一项独立的服务，作为糖尿病前期教育课程的补充，并作为医生和护士执业建议的重要加强。