SMART Weight Loss Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Change in weight at 6 months
研究概览
简要总结
The overall objective of this study is to use an innovative experimental approach, the SMART (Sequential Multiple Assignment Randomized Trial), to determine the best way to sequence the delivery of mHealth tools and traditional treatment components in a stepped program of obesity treatments. The SMART approach is a highly efficient strategy for identifying and constructing efficacious adaptive interventions: it accommodates sequential decision-making based on the participant's response to early weight loss treatment components. The proposed treatment package begins with the least expensive components, and for participants identified as treatment non-responders, provides sequential step-up of additional treatment components. By sequentially delivering treatment components based on participant response, SMART permits achievement of the target outcome, weight loss, with least resource consumption and participant burden.
详细描述
The proposed study seeks to develop an effective, resource-sensitive strategy to manage weight loss treatment for obesity. During the 12-week active intervention phase, participants will be randomized to one of two first-line treatments: 1) mobile app alone (APP) or 2) app plus weekly telephone coaching sessions (APP+C). Beginning at week 2, those who are identified as treatment non-responders (did not lose an average of 0.5 lbs/week) will be re-randomized to one of two augmentation tactics: 1) Modest Step-up, operationalized as the addition of an additional mHealth component, or 2) Vigorous Step-up, operationalized as the addition of an additional mHealth component plus a traditional weight loss intervention component. Treatment responders will continue with the same first-line treatment. Treatment response be re-assessed at weeks 4 and 8. Those identified as treatment non-responders will be re-randomized at that time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 through 60 years old
- •BMI between 27 - 45 kg/m2
- •< 350 lbs
- •Weight stable (no loss or gain >25 lbs. for the past 6 months)
- •Interested in losing weight and not enrolled in a formal weight loss program or taking medications or supplements that may cause weight change
- •Own a Smartphone and be willing to install the SMART App
- •Reside in the Chicago area for the duration of their participation (12 months)
排除标准
- •Unstable medical conditions (uncontrolled hypertension, diabetes - uncontrolled or treated with insulin, uncontrolled hypothyroidism, unstable angina pectoris, transient ischemic attack, cancer undergoing active treatment, cerebrovascular accident or myocardial infarction within the past six months, or Crohn's disease)
- •Pregnancy, lactation, or intended pregnancy
- •Active suicidal ideation, anorexia, bulimia, binge eating disorder, current substance abuse or dependence (besides nicotine dependence)
- •Require assistive device for mobility or current condition that may limit or prevent participation in moderate activity
- •Use of pacemaker or other electrical implanted device
- •History of bariatric (or LapBand) surgery, or considering or currently on a wait-list for bariatric or LapBand surgery
- •May not live with a current or past SMART study participant
结局指标
主要结局
Change in weight at 6 months
时间窗: baseline, 6 months
Weight measured in the lab, taken without shoes, wearing light clothing on a calibrated beam balance scale
次要结局
未报告次要终点
研究者
Bonnie Spring
Professor
Northwestern University