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: 7104409
• 负责人: Kevin Patrick
• 金额: $ 52.21万
• 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 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7104409
• 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）： 改善体力活动 (PA) 和饮食行为以及减少超重或肥胖显示出降低成人 2 型糖尿病风险的巨大希望。然而，很少有干预措施能够解决这个问题，而且没有任何干预措施对初级保健提供者有用，也没有解决降低青少年糖尿病风险的干预措施。我们提出了一项随机对照试验，以评估综合初级保健和基于网络的干预措施 PACEi-DP 是否可以对符合 ADA“高风险”标准的青少年的人体测量、行为、代谢和生理结果产生初步和持续的改善。 “对于 2 型糖尿病。 PACEi-DP 是一项为期 1 年的干预措施，涉及： a) 学前保健就诊网络评估和进度规划； b) 临床医生咨询； c) 12 个月的网络、电话和/或小组跟进。基于 PACEi-DP 选定要素的试点研究证明了其在改善超重青少年的饮食和 PA 行为以及稳定 BMI 方面的前景。我们将招募 93 名年龄在 12 岁至 16 岁之间、符合 ADA 2 型糖尿病高风险标准的青少年。受试者将从 5 个医疗机构和社区中招募，并随机分配到以下三种情况之一：1) 常规医疗护理； 2) 基于网络的 PACEi-DP 版本，其中后续部分涉及与受试者及其家长/监护人进行基于网络的异步联系；或 3) 多模式 PACEi-DP，其中后续组件添加电话和群组联系人。 PACEi-DP 将针对 4 种行为：1）中度和剧烈 PA 的总能量消耗； 2）久坐行为和娱乐媒体的使用； 3) 水果/蔬菜/纤维摄入量（每天 5 份或更多水果/蔬菜，以及每天 3 份或更多全谷物或豆类）； 4) 总脂肪占消耗能量的百分比。该干预措施指导患者选择 PA 和饮食目标行为，并制定行动计划与临床医生讨论。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。网络教程、持续的网络访问、电子邮件互动以及（第 3 组）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 使参与者能够接受针对其饮食和 PA 目标的量身定制的、适合阶段的干预措施。主要结果是 PACEi-DP 对 12 个月时 BMI 的影响。次要结果（第 6 个月和第 12 个月）将是：a) 胰岛素抵抗的代谢和生理测量（空腹胰岛素、空腹血糖、血脂、微量白蛋白尿、黑棘皮病和血压；b）人体测量测量（体脂百分比）通过 DEXA（12 个月时）、腰臀比；c) 行为测量（中度和剧烈的 PA；总能量消耗；CSA；久坐行为和娱乐媒体使用的测量；水果、蔬菜和纤维的份量；以及总脂肪占能量消耗的百分比。探索性测量将包括父母/监护人体重指数和腰臀比的社会心理测量，以及过程、满意度和成本效益测量。每个研究组都特别具有创新性，因为它的三个组成部分——访问前网络评估和行为改变计划、初级保健提供者咨询以及持续的网络或网络/电话/团体干预——通过共同的行为统一起来。理论框架。

项目成果

Outcomes of a 12-month technology-based intervention to promote weight loss in adolescents at risk for type 2 diabetes.

为期 12 个月的基于技术的干预措施的结果，旨在促进有 2 型糖尿病风险的青少年减肥。

• DOI: 10.1177/193229681300700322
• 发表时间: 2013
• 期刊: Journal of diabetes science and technology
• 影响因子: 5
• 作者: Patrick,Kevin;Norman,GregoryJ;Davila,EvelynP;Calfas,KarenJ;Raab,Fred;Gottschalk,Michael;Sallis,JamesF;Godbole,Suni;Covin,JenniferR
• 通讯作者: Covin,JenniferR