Testing Just-in-Time Adaptive Interventions (JITAIs) to Prevent Goal Disengagement in Response to Weight Regain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Average Weekly MVPA
研究概览
简要总结
This trial will test the effectiveness of a weight loss maintenance intervention designed to help participants respond more adaptively to weight regain. Participants will be randomly assigned to one of two conditions. In one condition, participants will receive brief exercises (e.g., written reflections, videos) sent to through a smartphone app immediately after they regain weight or miss a weigh-in. These exercises will use mindfulness, acceptance, and self-compassion strategies to help participants stay motivated for their long term goals, even when weight regain feels demoralizing. In the comparison condition, participants will receive weekly reminders of standard weight control strategies strategies.
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
- 否
入选标准
- •Ages 18-70 years
- •BMI of 25-50 kg/m2
- •Current weight is 3% lower than their highest weight in the past 3 years
- •Desire to maintain their weight or lose more
- •Ability to engage in PA, as defined as being able to walk two full city blocks without stopping
- •Smartphone and Internet access
- •Successful completion of all enrollment procedures
- •Ability to attend a workshop(s) on a Monday or Tuesday evening
排除标准
- •History of bariatric surgery
- •History of being diagnosed with an eating disorder
- •Currently pregnant, breastfeeding, or planning to become pregnant in the next 24 months
- •Enrolled in another formal weight loss/weight maintenance program
- •Currently taking a GLP-1 medication.
研究组 & 干预措施
Active Control Condition
Participants in this condition will receive minimal intervention designed to reflect "usual care" for weight loss maintenance.
干预措施: Active Control (Behavioral)
JITAI Condition
Participants in this condition will receive a 6-month weight loss maintenance intervention that uses mindfulness, acceptance, and self-compassion strategies to respond to weight regain.
干预措施: JITAI Combined with psychological intervention (Behavioral)
结局指标
主要结局
Average Weekly MVPA
时间窗: 6 months (duration of study period)
Average total minutes of weekly moderate-to-vigorous physical activity, as tracked by their Fitbit band, during the study period.
State negative affect
时间窗: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Through ecological assessment surveys, participants will respond to a single item measuring their current negative affect.
State shame
时间窗: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Through ecological assessment surveys, participants will respond to a single item measuring their current shame.
State Motivation
时间窗: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Through ecological assessment surveys, participants will respond to a single item measuring their current feelings of motivation.
State Self-Efficacy
时间窗: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Through ecological assessment surveys, participants will respond to a single item measuring their current self-efficacy.
Current confidence in the effectiveness of weight control behaviors
时间窗: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Through ecological assessment surveys, participants will respond to a single item measuring their current confidence in the effectiveness of weight control behaviors.
State self-compassion
时间窗: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Through ecological assessment surveys, participants will respond to a single item measuring their state self-compassion.
State mindfulness
时间窗: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Through ecological assessment surveys, participants will respond to a single item measuring their state mindfulness.
State acceptance
时间窗: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Through ecological assessment surveys, participants will respond to a single item measuring their state acceptance.
Self-serving interpretation of weight gain
时间窗: Whenever participants regain weight during the 6 month study period
Through ecological assessment surveys, participants will respond to a single item measuring their self-serving interpretation of the weight regain.
Daily Calorie Tracking (Yes/No)
时间窗: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Whether participants log their calories (at least 800 calories) using a dietary tracking app that day (yes/no).
Daily MVPA
时间窗: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Minutes of moderate-to-vigorous physical activity they engage in that day, as tracked by their Fitbit band.
Likelihood of weighing in the following day
时间窗: Whenever participants skip a weigh-in or regain weight during the 6 month study period
Likelihood that participants weigh themselves the following day on a wireless smart scale (yes/no).
Calorie Tracking Frequency
时间窗: 6 months (duration of study period)
The number of days that participants logged their calories (at least 800 calories) using a dietary tracking app during the study period.
Frequency of Weighing In
时间窗: 6 months (duration of study period)
Total number of days that participants weighed themselves on a wireless smart scale during the study period.
Weight change
时间窗: End of treatment (6 months after baseline)
Using participants' weights from a wireless scale, their percent weight change from the beginning to the end of the study period will be calculated.
Intervention acceptability
时间窗: End of treatment (6 months after baseline)
Intervention acceptability will be operationalized as the percent of participants who indicate that they are "satisfied" or "very satisfied" with the program on an anonymous survey that they complete during their individual interview.
次要结局
- Mindfulness (Hypothesized intervention mediator)(Mid-Treatment (3 months after baseline))
- Acceptance (Hypothesized intervention mediator)(Mid-Treatment (3 months after baseline))
- Self-compassion (Hypothesized intervention mediator)(Mid-Treatment (3 months after baseline))