Testing Just-in-Time Adaptive Interventions (JITAIs) to Prevent Goal Disengagement in Response to Weight Regain (Momentum)
2026年8月7日 更新者:ORI Community and Evaluation Services
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.
研究概览
研究类型
介入性
注册 (估计的)
120
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Charlotte Hagerman, PhD
- 电话号码:14109372035
- 邮箱:chagerman@ori.org
学习地点
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Oregon
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Springfield、Oregon、美国、97477
- 招聘中
- Oregon Research Institute Community and Evaluation Services
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接触:
- Charlotte Hagerman, PhD
- 电话号码:4109372035
- 邮箱:chagerman@ori.org
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的: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.
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For six months, participants will receive a just-in-time adaptive interventions via a smartphone app immediately after they gain weight or they skip a weigh-in (according to a specific algorithm).
Interventions will engage participants in mindfulness, acceptance, and self-compassion-based (MASC) strategies through different modalities (e.g., writing exercises, videos, audio reflections).
They will take approximately 1-10 minutes.
Participants will also attend an introductory workshop, during which they will receive the instructions weigh daily, learn the importance of quickly responding to weight regain, and be introduced to MASC strategies.
They will also attend two booster workshops during the 6-month period.
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有源比较器:Active Control Condition
Participants in this condition will receive minimal intervention designed to reflect "usual care" for weight loss maintenance.
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For six months, participants will receive weekly, automated messages via a smartphone app with reminders of standard behavioral weight control principles.
Participants will attend an introductory workshop, during which they will receive instructions to weigh daily and learn the importance of responding to weight regain.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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State negative affect
大体时间:Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Through ecological assessment surveys, participants will respond to a single item measuring their current negative affect.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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State shame
大体时间:Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Through ecological assessment surveys, participants will respond to a single item measuring their current shame.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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State Motivation
大体时间:Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Through ecological assessment surveys, participants will respond to a single item measuring their current feelings of motivation.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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State Self-Efficacy
大体时间:Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Through ecological assessment surveys, participants will respond to a single item measuring their current self-efficacy.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Current confidence in the effectiveness of weight control behaviors
大体时间:Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Through ecological assessment surveys, participants will respond to a single item measuring their current confidence in the effectiveness of weight control behaviors.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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State self-compassion
大体时间:Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Through ecological assessment surveys, participants will respond to a single item measuring their state self-compassion.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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State mindfulness
大体时间:Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Through ecological assessment surveys, participants will respond to a single item measuring their state mindfulness.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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State acceptance
大体时间:Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Through ecological assessment surveys, participants will respond to a single item measuring their state acceptance.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Self-serving interpretation of weight gain
大体时间:Whenever participants regain weight during the 6 month study period
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Through ecological assessment surveys, participants will respond to a single item measuring their self-serving interpretation of the weight regain.
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Whenever participants regain weight during the 6 month study period
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Daily Calorie Tracking (Yes/No)
大体时间:Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Whether participants log their calories (at least 800 calories) using a dietary tracking app that day (yes/no).
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Daily MVPA
大体时间:Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Minutes of moderate-to-vigorous physical activity they engage in that day, as tracked by their Fitbit band.
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Likelihood of weighing in the following day
大体时间:Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Likelihood that participants weigh themselves the following day on a wireless smart scale (yes/no).
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Whenever participants skip a weigh-in or regain weight during the 6 month study period
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Calorie Tracking Frequency
大体时间:6 months (duration of study period)
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The number of days that participants logged their calories (at least 800 calories) using a dietary tracking app during the study period.
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6 months (duration of study period)
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Average Weekly MVPA
大体时间:6 months (duration of study period)
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Average total minutes of weekly moderate-to-vigorous physical activity, as tracked by their Fitbit band, during the study period.
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6 months (duration of study period)
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Frequency of Weighing In
大体时间:6 months (duration of study period)
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Total number of days that participants weighed themselves on a wireless smart scale during the study period.
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6 months (duration of study period)
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Weight change
大体时间:End of treatment (6 months after baseline)
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Using participants' weights from a wireless scale, their percent weight change from the beginning to the end of the study period will be calculated.
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End of treatment (6 months after baseline)
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Intervention acceptability
大体时间:End of treatment (6 months after baseline)
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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.
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End of treatment (6 months after baseline)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mindfulness (Hypothesized intervention mediator)
大体时间:Mid-Treatment (3 months after baseline)
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Participants will self-report their mindfulness using the Awareness subscale of The Philadelphia Mindfulness Scale.
The range of scores is 1-5, with higher scores indicating greater mindfulness.
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Mid-Treatment (3 months after baseline)
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Acceptance (Hypothesized intervention mediator)
大体时间:Mid-Treatment (3 months after baseline)
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Participants will self-report their mindful acceptance using the Acceptance subscale of The Philadelphia Mindfulness Scale.
The range of scores is 1-5, with higher scores indicating greater mindful acceptance.
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Mid-Treatment (3 months after baseline)
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Self-compassion (Hypothesized intervention mediator)
大体时间:Mid-Treatment (3 months after baseline)
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Participants will report their self-compassion using the Self-Compassion Scale Short Form.
Scores can range from 1 to 5, with higher scores indicating higher self-compassion.
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Mid-Treatment (3 months after baseline)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年7月14日
初级完成 (估计的)
2027年12月31日
研究完成 (估计的)
2027年12月31日
研究注册日期
首次提交
2026年7月12日
首先提交符合 QC 标准的
2026年7月12日
首次发布 (实际的)
2026年7月16日
研究记录更新
最后更新发布 (实际的)
2026年8月11日
上次提交的符合 QC 标准的更新
2026年8月7日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.