Goal Setting to Promote Physical Activity Adherence in Midlife to Reduce Risk of Alzheimer's Disease and Related-Dementias: A Randomized Mechanistic Proof-of-Concept Trial

设定目标以促进中年体力活动的坚持，以降低阿尔茨海默氏病和相关痴呆症的风险：随机机械概念验证试验

• 批准号: 10696085
• 负责人: Rodney Joseph
• 金额: $ 19.06万
• 依托单位: ARIZONA STATE UNIVERSITY-TEMPE CAMPUS
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10696085
• 关键词: Accelerometer; Adherence; Adult; Age; Alzheimer' s disease diagnosis; Alzheimer' s disease related dementia; Alzheimer' s disease risk; American; Amyloid; Amyloid beta-Protein; Behavior; Biological Markers; Blood Pressure; Body mass index; Brain-Derived Neurotrophic Factor; Cardiometabolic Disease; Caregivers; Cholesterol; Cognitive; Control Groups; Dose; Dyslipidemias; Ethnic Origin; Family; Feedback; Glucose; Goals; Guidelines; Health Campaign; Health Personnel; Healthcare Systems; Heterogeneity; High Density Lipoproteins; Hypertension; Impairment; Individual; Informal Social Control; Insulin; Intervention; Language; Life Style; Literature; Low-Density Lipoproteins; Manuals; Measures; Mediating; Mediator; Memory; Mental Depression; Monitor; Nerve Degeneration; Obesity; Outcome; Oxidative Stress; Participant; Pathogenesis; Phase; Physical activity; Pilot Projects; Plasma; Process; Protocols documentation; Public Health; Race; Randomized; Recommendation; Reporting; Research; Research Personnel; Risk; Risk Reduction; Self Determination; Self Efficacy; Symptoms; Tauopathies; Techniques; Testing; Very low density lipoprotein; Work; adult obesity; arm; behavior change; cognitive function; daily functioning; dementia risk; disorder risk; executive function; experience; fitbit; follow-up; group intervention; improved; insulin sensitivity; intervention delivery; intervention refinement; lifestyle factors; middle age; neurogenesis; neuroinflammation; processing speed; psychosocial; randomized trial; response; sex; successful intervention; synaptogenesis; tau-1; theories

Project Summary More than 6 million U.S. adults live with diagnoses of Alzheimer's Disease and Related Dementias (AD/ADRD), with projections as high as 13.8 million cases by 2050. There are no cures for AD/ADRD, making lifestyle factors key targets for reducing risk, as they account for at least a third of AD/ADRD cases. Engaging in regular physical activity (PA), particularly in midlife, is associated with reduced risk for AD/ADRD. Yet nearly half of midlife adults (48%) do not meet national PA guidelines of 150 minutes/week of moderate-intensity PA. Goal setting is a commonly used behavior change strategy to increase PA. Key psychosocial mechanisms believed to underpin the use of goal setting to promote PA include self-regulation and self-efficacy. Yet, the most effective goal setting technique to enhance these psychosocial mechanisms for the successful promotion of PA and adherence to national PA guidelines remains unclear. In the proposed study, we will use a two- phased approach to empirically test three goal setting techniques to enhance psychosocial mechanisms of self- regulation and self-efficacy for the successful promotion of PA and adherence to national PA guidelines among insufficiently active midlife adults with obesity. In the R61 phase, a Phase 1 pilot study will establish feasibility and help refine the intervention. In the R33 phase, a Phase 2 9-month 4-arm proof-of-concept mechanistic trial (6-month active intervention and 3-month no contact follow-up) will be implemented to establish preliminary efficacy of goal setting techniques to increase PA and promote adherence to national PA guidelines. All participants will receive a Fitbit to self-monitor PA and engage in PA action planning sessions with a study interventionist. In addition, participants will be randomly assigned to 1 of 4 groups: i) static weekly goal of 150 minutes/week of moderate-intensity PA, which most closely resembles the approach of public health campaigns and care providers; ii) weekly self-selected PA goals, which allows for self-determination and adaptation of the goal; iii) modest incremental weekly PA increase goal (i.e., researcher determined PA goal that 20% minutes/week greater than the minutes/week of PA in the previous week); or iv) non-goal setting control group. Based on Goal Setting Theory, it is hypothesized that participants in the incremental goal group will have the greatest increases in self-regulation and self-efficacy, which in turn, will lead to the greatest improvements in PA and adherence to national PA guidelines over the 9-month intervention. Further, individuals with the greatest PA adherence are expected to experience the greatest improvements in AD/ADRD risk factors, including cognitive functioning (memory, executive functioning, processing speed), AD plasma biomarkers (plasma amyloid 42/40 ratio. plasma phosphorylated tau 231), and measures of cardiometabolic disease risk (BMI, blood pressure, plasma glucose, TG, total cholesterol, LDL-C, HDL-C, VLDL-C, IDL-C, insulin and insulin sensitivity).

项目摘要 超过600万美国成年人患有阿尔茨海默病和相关痴呆症 (AD/ADRD），预计到2050年病例数将高达1380万例。AD/ADRD没有治愈方法， 生活方式因素是降低风险的关键目标，因为它们至少占AD/ADRD病例的三分之一。从事 定期的身体活动（PA），特别是在中年，与AD/ADRD风险降低有关。然而近 一半的中年人（48%）不符合每周150分钟中等强度PA的国家PA指南。 目标设定是一种常用的行为改变策略，以提高PA。主要心理社会机制 据信，支持使用目标设定来促进PA的因素包括自我调节和自我效能。然而 最有效的目标设定技术，以加强这些心理社会机制，成功的促进 PA和遵守国家PA指南仍不清楚。在本研究中，我们将使用两个- 分阶段的方法，实证测试三个目标设定技术，以提高自我的心理社会机制， 监管和自我效能的成功促进PA和遵守国家PA的指导方针， 缺乏活动的中年肥胖症患者在R61阶段，第1阶段试点研究将确定可行性 并帮助完善干预措施。在R33阶段，一项为期9个月的2期4组概念验证机制试验 （6个月的主动干预和3个月的无接触随访），以建立初步的 目标设定技术提高绩效评估和促进遵守国家绩效评估准则的有效性。所有 参与者将获得一个Fitbit来自我监测PA，并参与PA行动计划会议， 干涉主义者。此外，参与者将被随机分配到4组中的1组：i）静态每周目标为150 分钟/周的中等强度PA，这最接近于公共卫生的方法 运动和护理提供者; ii）每周自选的PA目标，允许自决， 目标的调整; iii）适度递增的每周PA增加目标（即，研究人员确定的PA目标 比前一周PA的分钟数/周多20%分钟数/周）;或iv）非目标设定 对照组根据目标设置理论，假设增量目标组的参与者 在自我调节和自我效能方面会有最大的提高，这反过来又会导致最大的 在9个月的干预期间，PA的改善和对国家PA指南的遵守。此外，本发明还 PA依从性最高的个体预期AD/ADRD的改善最大 风险因素，包括认知功能（记忆、执行功能、处理速度）、AD血浆 生物标志物（血浆淀粉样蛋白42/40比率。血浆磷酸化tau蛋白231），以及心脏代谢指标 疾病风险（BMI、血压、血糖、TG、总胆固醇、LDL-C、HDL-C、VLDL-C、IDL-C， 胰岛素和胰岛素敏感性）。