Stepped Care for Weight Loss Maintenance

减肥保养的阶梯护理

基本信息

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
项目类别：
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

项目摘要

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

项目概要/摘要维持减肥仍然是肥胖管理的致命弱点。延长干预接触减少体重反弹。然而，在实践中持续进行咨询的情况很少见。数字健康干预措施可以解决提供现场维护咨询的障碍。我们的长期目标是开发更多有效的减肥维持策略，易于使用，以患者为中心，并根据需要量身定制个人的需求。为了实现这一目标，拟议的试验将检查是否在初始治疗 16 周后减肥是一种阶梯式护理、数字化健康干预措施，可以改善体重减轻>5%的维持情况。阶段我生活方式阶段，（加州大学）；（步）。自己是一个非随机的、为期 16 周的减肥阶段，在此期间所有参与者将接受同一组旨在诱导体重减轻 > 5% 的干预措施。第二阶段，为期 52 周的减肥维持 180 名体重下降超过 5% 的肥胖成年人将被随机接受三种干预措施之一：常规护理使用数字工具每天自我监测体重、饮食和身体活动（SELF）；或者 UC 小组将每月接受通过电子邮件发送的减肥维持教育。参加者小组将可以获得数字健康干预措施，该干预措施使用：我分级护理每日远程监测体重，体力活动和卡路里摄入量；以及自动化、个性化的短信坚持。 13 此外（步百分比几周，过渡鼓励行为a 从访问数字健康计划开始（步骤 1）。参加第一场比赛后几周内，体重减轻幅度未保持 5% 或体重恢复 2%，将每月接受辅导员拜访，以促进行为依从性并解决障碍 2）。 26 周时体重减轻未保持 > 5% 或体重恢复 2% 的参与者第 2 步的积分将转变为每月两次的咨询（第 3 步）。 39岁的参与者仍然没有保持 > 5% 的体重减轻或通过步骤 3 恢复了 2 个百分点过去 13 周的部分代餐计划（步骤 4）。我步骤将我们的主要目标是确定是否与 UC 相比，SELF 和 STEP 可以更好地维持减肥效果。我们的次要目标是检查自我称重频率、饮食行为和体力活动的差异，并检查 STEP、相对于 SELF，在体重、自我称重频率、饮食行为和体力活动。每个我们还将进行经济分析，以评估增量成本效益每单位体重减少（公斤）的干预措施。该研究的预期结果是证明数字健康干预对维持减肥的功效，为许多挑战提供了解决方案干扰肥胖治疗的成功实施。我们还期望展示阶梯式的功效减肥维持护理模式，提供个人对治疗的反应。解决显着异质性的策略