PACEi-DP: An Intervention for Youth at Risk for Diabetes

PACEi-DP：针对有糖尿病风险的青少年的干预措施

• 批准号: 6606247
• 负责人: Kevin Patrick
• 金额: $ 66.71万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-01 至 2007-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6606247
• 关键词: Internet; acanthosis nigricans; adipose tissue; adolescence (12-20); behavioral /social science research tag; blood glucose; blood lipid; blood pressure; body composition; clinical research; clinical trials; cost effectiveness; diabetes education; diet; disease /disorder prevention /control; exercise; health behavior; high risk behavior /lifestyle; human subject; insulin sensitivity /resistance; noninsulin dependent diabetes mellitus; parents; patient oriented research; psychometrics

DESCRIPTION (provided by applicant): Improved physical activity (PA) and dietary behaviors and reductions in overweight or obesity show great promise to reduce the risk of type 2 diabetes in adults. However, very few interventions have been reported that address this issue, and none that are useful for primary care providers or that address reducing diabetes risk in adolescents. We propose a randomized controlled trial to evaluate whether an integrated primary care and web-based intervention, PACEi-DP, can produce initial and sustained improvements in anthropometric, behavioral, metabolic, and physiological outcomes in adolescents who meet the ADA criteria for "high risk" for type 2 diabetes. PACEi-DP is a 1- year intervention involving: a) pre-primary care visit web assessment and progress planning; b) clinician counseling; c) 12 months of web-based, phone and/or group-based follow-up. Pilot studies based upon selected elements of PACEi-DP demonstrate its promise in improving dietary & PA behaviors and in stabilizing BMI in overweight adolescents. We will recruit 93 adolescents, age 12 to 16 years, who meet the ADA criteria for high risk of Type 2 diabetes. Subjects will be recruited from 5 healthcare settings and the community and randomly assigned to one of three conditions: 1) usual medical care; 2) a web-based version of PACEi-DP where the follow-up component involves asynchronous web-based contact with subjects and their parent/guardian; or 3) a multi-modal PACEi-DP where the follow-up component adds phone and group contact. PACEi-DP will target 4 behaviors: 1) total energy expenditure from moderate and vigorous PA; 2) sedentary behavior and recreational media use; 3) Fruit/Vegetable/Fiber consumption (5 or more servings/day of fruits/vegetables and 3 or more servings/day of whole grains or legumes); and 4) total fat as percent of energy consumed. The intervention guides patients to select PA & diet target behaviors for which they develop action plans to discuss with the clinician. The clinician endorses or modifies the action plan and encourages participation in the ongoing intervention. Web-tutorials, continuous web access, e-mail interaction, and (in Group 3) phone counseling and group meetings guide patients and parent/guardian to use cognitive & behavioral skills to change behaviors. PACEi-DP enables participants to receive tailored, stage-appropriate intervention on their diet & PA goals. The primary outcome will be the effect of PACEi-DP on BMI at 12 months. Secondary outcomes (at 6 and 12 mo.) will be: a) metabolic and physiological measures of insulin resistance (fasting insulin, fasting blood glucose, blood lipids, microalbuminuria, acanthosis nigricans, and blood pressure; b) anthropometric measures ( percent body fat by DEXA (at 12 months), waist/hip ratios; c) behavioral measures (moderate & vigorous PA; total energy expenditure; CSA; measures of sedentary behavior & recreational media use; servings of fruits, vegetables & fiber; and total fat as a percent of energy consumed. Exploratory measures will include psychosocial mediators of change; measures of parent/guardians' BMI and waist/hip ratios, and process, satisfaction & cost-effectiveness measures of each study arm. The PACEi-DP intervention is particularly innovative because its three components - pre-visit web assessment and behavior change planning, primary care provider counseling, and the ongoing web or web/phone/group intervention -are unified through a common behavioral theoretical framework.

描述（由申请人提供）： 改善的体育锻炼（PA）和饮食行为以及超重或肥胖的减少表现出巨大的希望，可以降低成人2型糖尿病的风险。但是，很少有干预措施报道解决此问题，而没有针对初级保健提供者有用的干预措施，或者解决了降低青少年糖尿病风险的问题。我们提出了一项随机对照试验，以评估综合的初级保健和基于Web的干预措施PACEI-DP是否可以在符合2型2型糖尿病的“高风险”的ADA标准的青少年中对人体测量，行为，代谢和生理结果的初始和持续改进。 PACEI-DP是一项1年的干预措施：a）基本护理访问网络评估和进度计划； b）临床医生咨询； c）基于Web的12个月，电话和/或基于组的随访。基于PACEI-DP选定元素的试点研究表明，其在改善饮食和PA行为以及稳定超重青少年的BMI方面的希望。我们将招募93名12至16岁的青少年，他们符合ADA标准的2型糖尿病风险。受试者将从5个医疗机构和社区中招募，并随机分配到三个条件之一：1）通常的医疗服务； 2）基于Web的PACEI-DP版本，其中后续组件涉及与受试者及其父/监护人的基于Web的异步联系；或3）随访组件添加电话和组联系人的多模式PACEI-DP。 PACEI-DP将针对4个行为：1）中度和剧烈PA的总能量消耗； 2）久坐的行为和娱乐媒体使用； 3）水果/蔬菜/纤维消耗（5份或更多份量/天的水果/蔬菜以及3份或更多食用/天的全谷物或豆类）； 4）总脂肪是消耗能源百分比。干预指导患者选择PA和饮食目标行为，以制定与临床医生讨论的行动计划。临床医生认可或修改行动计划，并鼓励参与正在进行的干预措施。网络教程，连续的网络访问，电子邮件交互以及（在第3组中）电话咨询和小组会议指导患者和家长/监护人使用认知和行为技能来改变行为。 PACEI-DP使参与者能够就饮食和PA目标进行量身定制的，适合阶段的干预。主要结果将是Pacei-DP在12个月时对BMI的影响。 Secondary outcomes (at 6 and 12 mo.) will be: a) metabolic and physiological measures of insulin resistance (fasting insulin, fasting blood glucose, blood lipids, microalbuminuria, acanthosis nigricans, and blood pressure; b) anthropometric measures ( percent body fat by DEXA (at 12 months), waist/hip ratios; c) behavioral measures (moderate & vigorous PA；很重要因为它的三个组件 - 访问前的Web评估和行为变更计划，初级保健提供商咨询以及正在进行的Web或Web/Phone/Group Issestions-通过共同的行为理论框架统一。