Stepped Care for Weight Loss Maintenance
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Weight (kg) change for STEP versus usual care
研究概览
简要总结
This study is a 3-group, parallel design, randomized controlled trial (RCT) in approximately 258 adults with obesity that will investigate whether a 16-week behavioral weight loss treatment and a 52-week stepped-care digital health intervention can improve the maintenance of a ≥ 5% weight loss.
16-week run-in (Phase 1). To qualify for randomization, participants must lose ≥ 5% of initial weight in the 16-week run-in. This loss will be achieved with the provision of weekly-group lifestyle counseling, which includes a partial meal replacement diet.
52-week randomized trial of 3 weight loss maintenance strategies (Phase 2): Participants who have achieved ≥ 5% weight loss during Phase 1 will be randomly assigned to 1 of 3 groups:
- Participants in the Usual Care group will be emailed monthly educational modules with information on maintaining weight loss.
- Participants in the SELF group will receive a wireless "smart" body weight scale and a wearable physical activity tracker, and daily text messages with tailored feedback to assist in weight loss maintenance.
- Participants in the STEP group will be enrolled in an intervention that consists of 4 steps that are progressive and based on response to treatment. After 13 weeks at each step, participants who do not maintain a ≥5% weight loss or regain 2 percentage points of weight from the participants randomization value will move to a higher intensity step. Participants who maintain weight loss will stay at the same step.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI>/=30 kg/m2 or >/=27 kg/m2 with an obesity-related complication
- •Age 18-70 years
- •Completion of baseline assessment tasks
- •Ability to engage in physical activity
- •Own a smartphone capable of receiving text-messages and syncing to weight scales and physical activity trackers
- •Home wireless access
排除标准
- •Serious medical condition or psychiatric condition that may pose a risk to the participant during intervention, cause a change in weight, or limit ability to adhere to the behavioral recommendations of the program
- •Pregnant or planning pregnancy in the next 1.5 years
- •Weight>440 lbs
- •Planned move out of the area in the next 1.5 years
- •Recently began a course of or changed the dosage of medication that can cause significant change in weight
- •History of bariatric surgery
- •Weight loss of >5% in the previous 6 months
- •Household member already participating in study
研究组 & 干预措施
Usual care
Usual care
干预措施: Usual care (Behavioral)
Text-message intervention with digital tools (SELF)
Text-message intervention
干预措施: SELF (Behavioral)
Stepped Care (STEP)
Stepped care
干预措施: STEP (Behavioral)
结局指标
主要结局
Weight (kg) change for STEP versus usual care
时间窗: Baseline, 52 weeks
Weight change (kg) for STEP versus usual care
Weight (kg) change for SELF versus usual care
时间窗: Baseline, 52 weeks
Weight change (kg) for SELF versus usual care
次要结局
- Change in self-weighing frequency (days) for STEP and SELF versus usual care(Baseline, 52 weeks)
- Change in daily calorie intake for STEP and SELF vs usual care(Baseline, 52 weeks)
- Change in physical activity (minutes) for STEP and SELF versus usual care(Baseline, 52 weeks)
- Weight (kg) change for STEP versus SELF(Baseline, 52 weeks)
- Change in days of self-weighing for STEP versus SELF(Baseline, 52 weeks)
- Change in daily calorie intake for STEP versus SELF(Baseline, 52 weeks)
- Change in self-reported minutes of Physical activity for STEP versus SELF(Baseline, 52 weeks)