Stepped Care for Weight Loss Maintenance

减肥保养的阶梯护理

• 批准号: 10584935
• 负责人: ARIANA MARIE CHAO
• 金额: $ 38.86万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-05 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10584935
• 关键词: Accelerometer; Address; Adherence; Behavior; Behavior Control; Behavior Therapy; Body Weight; Body Weight decreased; Calories; Caring; Chronic; Counseling; Diet; E-learning; Eating Behavior; Education; Effectiveness of Interventions; Electronic Mail; Energy Intake; Failure; Feedback; Frequencies; Goals; Healthcare; Heterogeneity; Individual; Intake; Intervention; Life Style; Maintenance; Methods; Modeling; Monitor; Nature; Obesity; Outcome; Outcome Study; Participant; Patient Self-Report; Patients; Persons; Phase; Physical activity; Professional counselor; Provider; Randomized; Relapse; Research; Resources; Schedule; Telephone; Text; Text Messaging; Time; Visit; Weight; Weight maintenance regimen; adult obesity; behavioral adherence; clinical practice; clinically significant; comorbidity; cost; digital health; digital tool; economic evaluation; flexibility; group intervention; implementation cost; improved; incremental cost-effectiveness; individual response; lifestyle intervention; novel; obesity management; obesity treatment; patient oriented; patient response; primary outcome; programs; remote monitoring; response; success; telemonitoring; theories; therapy design; tool; treatment as usual; treatment response; weight loss intervention; weight maintenance; wireless fidelity

PROJECT SUMMARY/ABSTRACT Weight loss maintenance remains the Achilles' heel of obesity management. Extended intervention contact reduces weight regain. However, continued counseling in practice is rare. Digital health interventions can address barriers to providing in-person maintenance counseling. Our long-term goal is to develop more effective weight loss maintenance strategies that are accessible, patient-centered, and tailored to meet individuals' needs. To accomplish this goal, the proposed trial will examine whether, after 16 weeks of initial weight loss, a stepped-care, digital health intervention improves the maintenance of a >5% weight loss. Phase I lifestyle phase, (UC); (STEP). SELF is a non-randomized, 16-week, weight-loss phase during which all participants wil receive the same group intervention designed to induce a > 5% weight l oss. In Phase II, a 52-week weight-loss maintenance 180 adults with obesity who have lost >5% will be randomized to one of three interventions: usual care daily self-monitoring of weight, diet, and physical activity with digital tools (SELF); or The UC group will receive monthly, emailed weight loss maintenance education. Participants in the group will have access to a digital health intervention that uses: l stepped care daily remote monitoring of weight, physical activity, and calorie intake; and automated, personalized text-messaging to adherence. 13 additionally (Step percentage weeks, transition encourage behaviora begin with access to the digital health program (Step 1). Participants who, after the first weeks, have not maintained their 5% weight loss or have regained 2 percentage points of their weight, will receive monthly visits with a counselor to promote behavioral adherence and address barriers 2). Participants who, at 26 weeks, have not maintained a > 5% weight loss or have regained 2 points with Step 2 will transition to twice-monthly counseling (Step 3). Participants who, at 39 still have not maintained a > 5% weight l oss or have regained 2 percentage points with Step 3 will to a partial meal replacement plan for the last 13 weeks (Step 4). l STEP will Our primary aim is to determine if SELF and STEP result in better maintenance of weight loss compared to UC. Our secondary aims are to examine differences in self-weighing frequency, eating behaviors, and physical activity, and examine if STEP, relative to SELF, produces greater improvements in weight, self-weighing frequency, eating behaviors, and physical activity. each We will also conduct an economic analysis to evaluate the incremental cost effectiveness of intervention per unit decrease in weight (kg).The expected outcome of the study is to demonstrate the efficacy of a digital health intervention for weight loss maintenance, providing a solution to many challenges that interfere with successful delivery of obesity treatment. We also expect to show the efficacy of a stepped care model for weight loss maintenance, providing a individuals' responses to treatment. strategy to address themarked heterogeneity in

项目总结/摘要 保持减肥仍然是肥胖管理的致命弱点。扩展干预联系 减少体重反弹。然而，在实践中，持续的咨询是罕见的。数字健康干预可以 解决提供面对面维护咨询的障碍。我们的长期目标是开发更多 有效的减肥维持策略，可访问，以患者为中心，并量身定制，以满足 个人的需要。为了实现这一目标，拟议的试验将研究在最初的16周后， 减肥，一个阶梯式护理，数字健康干预改善了>5%的体重减轻的维持。相 我 生活方式 相位， (UC); （STEP）。 自我 是一个非随机的，为期16周的减肥阶段，在此期间，所有参与者将接受同一组 设计的干预诱导> 5%的重量损失。在第二阶段，52周的减肥维持 180名体重下降>5%的肥胖成年人将随机接受三种干预措施之一：常规护理 使用数字化工具（SELF）对体重、饮食和身体活动进行日常自我监测;或 UC小组将每月接受通过电子邮件发送的减肥维持教育。参与者 小组将获得数字健康干预措施，该干预措施使用： L 阶梯治疗 每日远程监控体重， 身体活动和卡路里摄入量;以及自动化，个性化的短信， 坚持。 13 另外 （步骤 百分比 数周， 过渡 鼓励行为 开始访问数字健康计划（步骤1）。参与者，在第一次 如果没有保持5%的体重减轻或体重恢复了2个百分点， 每月接受咨询师的访问，以促进行为依从性并解决障碍 2）的情况。在26周时，参与者没有保持> 5%的体重减轻或体重增加了2 第2步的积分将过渡到每月两次的咨询（第3步）。参与者在39岁时 仍然没有保持> 5%的重量损失或重新获得2个百分点，第3步将 过去13周的部分膳食替代计划（第4步）。 L 步骤将 我们的首要目标是确定 与UC相比，SELF和STEP可以更好地维持体重减轻。我们的次要目标是 检查自我称重频率，饮食行为和身体活动的差异，并检查STEP， 相对于自我，产生更大的改善体重，自我称重频率，饮食行为， 体力活动。 每个 我们亦会进行经济分析，以评估 研究的预期结果是证明， 数字健康干预对减肥维持的功效，为许多挑战提供解决方案 这会干扰肥胖症治疗的成功实施。我们还希望展示一种阶梯式的 护理模式的减肥维护，提供了一个 个人对治疗的反应。 解决显着异质性的策略