Using Tailored mHealth Strategies to Promote Weight Management among Adolescent and Young Adult Cancer Survivors

使用量身定制的移动健康策略促进青少年和年轻癌症幸存者的体重管理

• 批准号: 10650648
• 负责人: Jessica Gokee LaRose
• 金额: $ 64.79万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-01 至 2028-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10650648
• 关键词: Acceleration; Accelerometer; Adolescent and Young Adult; Adolescent and young adult cancer patients; Adult; Adverse effects; Aerobic Exercise; Aftercare; Age; Aging; Behavior; Behavioral; Behavioral Mechanisms; Biological Markers; Body Composition; Body Weight Changes; Body Weight decreased; Body mass index; Cancer Survivor; Cardiometabolic Disease; Cardiovascular Diseases; Clinical; Collection; Competence; Control Groups; Country; Coupled; Data; Development; Diabetes Mellitus; Diagnosis; Diet; Diet Monitoring; Dietary intake; Education; Ethnic Origin; Facebook; Feedback; Fostering; Future; Goals; Health; Health behavior change; Health education; Intervention; Late Effects; Life; Life Style; Link; Maintenance; Malignant Neoplasms; Measures; Mediating; Mediator; Mental Depression; Mobile Health Application; Monitor; Morbidity - disease rate; Obesity; Outcome; Overweight; Participant; Pattern; Persons; Phase; Physical activity; Population; Protocols documentation; Quality of life; Questionnaires; Race; Randomized; Randomized, Controlled Trials; Recording of previous events; Research; Risk; Risk Factors; SF-36; Sampling; Self Determination; Subgroup; Survivors; Telephone; Testing; Time; Treatment Efficacy; Treatment Protocols; Visit; Vulnerable Populations; Weight maintenance regimen; actigraphy; arm; behavior change; behavior prediction; cardiometabolic risk; clinical research site; comorbidity; comparative efficacy; comparison intervention; design; dietary; digital intervention; digital monitoring; digital tool; efficacy evaluation; efficacy testing; evidence base; exercise intervention; follow-up; food insecurity; frailty; health equity; high risk; improved; improved outcome; indexing; intervention effect; intervention participants; intrinsic motivation; lifestyle intervention; mHealth; mobile application; mortality; novel; obesity risk; obesogenic; peer support; post intervention; primary outcome; psychologic; psychosocial; remote delivery; resistance exercise; response; secondary outcome; sex; social health determinants; social networking website; tailored messaging; theories; therapy design; tool; treatment arm; treatment response; waist circumference; web site; weight loss intervention; weight loss program; weight maintenance; wireless; young adult

PROJECT ABSTRACT/SUMMARY Survivors of adolescent and young adult cancers (AYAs) are a vulnerable and underserved subgroup of survivors at increased risk for long-term health effects, including obesity, diabetes, cardiovascular disease, additional cancers, and frailty. Furthermore, over half of AYAs already have overweight or obesity and obesogenic lifestyle behaviors are common among AYAs, which exacerbates their cardiometabolic risk. Given that obesity is associated with poorer outcomes in cancer survivors, there is a critical need for weight management interventions—yet, no weight loss interventions have been developed to meet the unique needs of AYAs. Extant research, including our own preliminary data, indicate that AYAs prefer tailored interventions (both with respect to developmental stage and cancer context) that are delivered remotely via website or app. Thus, we propose to develop a 6-month mHealth weight management intervention designed specifically for AYA cancer survivors and test its efficacy in a randomized controlled trial. The intervention will be rooted in self-determination theory in order to bolster intrinsic motivation for health behavior change by enhancing perceived competence, relatedness, and autonomy. It will include evidence-based behavioral weight loss strategies adapted for AYA survivors (e.g., simplified dietary self-monitoring, adaptive goal-setting, tailored feedback on progress) as well as personalized dietary and physical activity goals. The intervention will be paired with digital monitoring tools (wireless scale and activity tracker), as well as access to a closed Facebook group to foster peer support. AYA survivors nationwide (N=240, diagnosed between ages 15-39 [current age 18-39], posttreatment, body mass index [BMI] 25-50kg/m2) will be randomized to one of two arms: 1) mHealth intervention as described above, or 2) self-guided (digital tools + health education + Facebook). Randomization will be stratified by BMI, sex, and race/ethnicity. Assessments will occur at 0, 3, 6, and 12 months. Percent weight change at 6 months (primary outcome) will be assessed using a remote collection protocol via video weigh-in and wireless scale to facilitate enhanced reach across the US. Secondary outcomes in the full sample include frailty (frailty index), objectively measured physical activity (ActiGraph GT9X Link), dietary intake (ASA24), and quality of life (SF-36), as well as questionnaires assessing hypothesized psychosocial mediators targeted by the intervention. A subsample of participants (n=80) will complete in-person visits at each clinical site at 0, 6, and 12 months to assess changes in body composition, waist circumference, frailty, and biomarkers of aging and cardiometabolic disease. We hypothesize that compared to the self-guided arm, AYAs in the intervention arm will manifest greater percent weight loss at 6 months and better maintenance of weight loss from 6 to 12 months. We also will examine the psychological and behavioral mechanisms of action to inform future optimization efforts, and explore demographic and clinical- related moderators of intervention response. Our findings will accelerate the development of effective remotely- delivered mHealth weight loss interventions to improve outcomes and reduce the burden of morbidity in AYAs.

项目摘要/总结 青少年和年轻成人癌症（AYAs）的幸存者是一个脆弱和服务不足的幸存者亚组 长期健康影响的风险增加，包括肥胖、糖尿病、心血管疾病、其他 癌症和虚弱此外，超过一半的AYA已经超重或肥胖和肥胖的生活方式 行为在AYA中很常见，这加剧了他们的心脏代谢风险。考虑到肥胖是 与癌症幸存者较差的结果相关，迫切需要体重管理 然而，没有减肥干预措施已经开发出来，以满足AYA的独特需求。现存 包括我们自己的初步数据在内的研究表明，AYA更喜欢量身定制的干预措施（无论是在尊重 发展阶段和癌症背景），通过网站或应用程序远程交付。因此，我们建议 制定一项为期6个月的mHealth体重管理干预措施，专门为AYA癌症幸存者设计， 在随机对照试验中测试其功效。干预将植根于自决理论， 为了通过增强感知能力，相关性， 和自主权。它将包括适应AYA幸存者的循证行为减肥策略（例如， 简化的饮食自我监测，自适应目标设定，定制的进展反馈）以及个性化的 饮食和身体活动目标。干预将与数字监测工具（无线秤和 活动跟踪器），以及访问一个封闭的Facebook组，以促进同行的支持。全国AYA幸存者 （N=240，诊断年龄为15-39岁[当前年龄为18-39岁]，治疗后，体重指数[BMI] 25- 50 kg/m2） 将被随机分配到两组之一：1）如上所述的移动健康干预，或2）自我引导（数字 工具+健康教育+ Facebook）。将按照BMI、性别和人种/种族对随机化进行分层。 将在0、3、6和12个月时进行评估。6个月时的体重变化百分比（主要结局）将为 通过视频称重和无线秤使用远程收集协议进行评估，以促进扩大覆盖范围 在美国各地。完整样本中的次要结局包括虚弱（虚弱指数），客观测量的身体状况， 活动（ActiGraph GT 9 X Link）、饮食摄入（ASA 24）和生活质量（SF-36）以及问卷 评估干预所针对的假设的心理社会中介。参与者的子样本（n=80） 将在0、6和12个月时在每个临床研究中心完成亲自访视，以评估身体成分的变化， 腰围，虚弱，以及衰老和心脏代谢疾病的生物标志物。我们假设 与自我引导组相比，干预组的AYA在6岁时体重减轻的百分比更大 月和更好的维持体重减轻6至12个月。我们还将研究心理和 行为作用机制，为未来的优化工作提供信息，并探索人口统计学和临床- 干预反应的相关主持人。我们的发现将加速有效的远程- 提供移动健康减肥干预措施，以改善结果并减少AYAs的发病率负担。