通过短信增加中年活动 (MASTERY)
2026年8月11日 更新者：Jeff C. Huffman, MD、Massachusetts General Hospital
多成分交互式短信干预促进中年成年人身体活动的随机试点试验
这是一项随机对照试点试验，与注意力匹配的对照条件相比，通过短信干预促进中年成年人的体力活动（MASTERY）。
MASTERY 干预采用每周一次的双向短信会话，持续 12 周，重点是开展活动以增强健康、设定体育活动目标以及学习技巧以减轻中年特有的压力。
研究概览
详细说明
这是一项随机对照试点试验，与注意力匹配的对照条件相比，采用多管齐下的干预措施促进中年成年人的身体活动（MASTERY）。
在 MASTERY 中，参与者将每周进行一次交互式双向短信“会话”（通过自动短信程序进行 5-10 分钟的双向短信交流），持续 12 周。
这些信息每周将按照相同的顺序集中在 3 个不同的领域：(1) 为中年成年人定制的基于幸福感的技能和指定活动，(2) 侧重于设定和实现每周活动目标的身体活动内容，以及 ( 3) 管理中年相关压力源的具体技能，这些压力源会阻碍活动。
主要结果是客观测量中度至剧烈体力活动（MVPA）。
次要结果包括 12 周时的可行性和可接受性以及其他活动相关、心理和功能结果。
研究类型
介入性
注册 (实际的)
116
阶段
- 阶段1
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。
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02114
- Massachusetts General Hospital
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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
45年 至 64年 (成人)
接受健康志愿者
不
描述
纳入标准：
- 中年状态（入学时年龄 45-64 岁）。
- 低基线体力活动（≤150 分钟/周 MVPA]）最初通过经过充分验证的 IPAQ 自我报告，然后在佩戴 7 天后通过加速度计确认。
排除标准：
- 现有冠状动脉疾病（CAD；使用标准冠状动脉狭窄定义或既往 ACS 通过心导管插入术诊断）。
- 限制体力活动的不相关状况（例如，拄着拐杖或助行器行走、最近或计划进行的手术，或其他导致增加中度至体力活动能力受到限制的状况）。
- 参与任何其他以心脏预防或健康为重点的计划（例如心脏康复）。
- 妨碍参与或知情同意的认知障碍，使用旨在评估参与研究的适宜性的六项筛选7进行评估。
- 无法流利地用英语说/写。
- 无法使用支持短信的电话。
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：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：掌握干预
参与者将完成积极的心理活动，努力实现体育活动目标，并使用减压技巧，然后完成每周的短信课程。
在前六周，参与者将回顾他们前一周进行的活动，了解新材料，选择当周进行的活动，并在短信会议期间设定新的身体活动目标。
在最后 6 周内，参与者将回顾之前目标的进展情况，设定新的身体活动目标，并选择本周使用的积极心理学和减压技能。
最后，在计划过程中，参与者将与学习培训师完成三次简短的通话，讨论进展情况。
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在 MASTERY 中，参与者将每周进行一次交互式双向短信“会话”（通过自动短信程序进行 5-10 分钟的双向短信交流），持续 12 周。
此外，研究培训师将与参与者进行 4 次简短的通话（第 1、4、7 和 12 周），以介绍该计划、评估进度、回答问题并提供支持。
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有源比较器：注意力控制
参与者将收到与 MASTERY 中提到的相同的身体活动部分，以及我们过去工作中提供有关身体活动的教育和指导的附加信息。
对照组参与者不会收到 PP 或中年相关内容。
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控制条件下的参与者还将每周收到一次短信。
为了确保时间匹配，该计划将像 MASTERY 一样进行 4 次电话登记（关于身体活动）。
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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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中等强度体力活动的变化 [MVPA]
大体时间：基线、6 周、12 周
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ActiGraph 加速度计经过验证，可以作为身体活动的测量手段，并已用于许多医学疾病患者身体活动的研究。
在此试验中，参与者将在基线时佩戴加速度计 1 周、6 周和 12 周。
我们将报告每天执行 MVPA 的平均分钟数从基线到 6 周和 12 周的变化。
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基线、6 周、12 周
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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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Proportion of Text Message Sessions Completed
大体时间：Weekly over 12 weeks.
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To assess the feasibility of the MASTERY intervention the automated platform will record rates of the proportion of text message sessions in which participants respond and set a physical activity goal.
The "proportion of text message sessions completed" will be calculated by dividing the number of sessions in which participants respond and set a physical activity goal by the total number of sessions initiated by the text message program.
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Weekly over 12 weeks.
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Mean Utility Ratings of Positive Psychology Text Messages
大体时间：6 weeks; 12 weeks
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Participants will rate the utility of the positive psychology text message sessions over the past six weeks on a scale of 0 (unhelpful) to 10 (very helpful).
The mean utility score from the Week 6 and Week 12 assessments was calculated using mixed effects regression, to account for variance both within and between participants.
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6 weeks; 12 weeks
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Mean Utility Ratings of Physical Activity Text Messages
大体时间：6 weeks; 12 weeks
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Participants will rate the utility of the physical activity text message sessions over the past six weeks on a scale of 0 (unhelpful) to 10 (very helpful).
The mean utility score from the Week 6 and Week 12 assessments was calculated using mixed effects regression, to account for variance both within and between participants.
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6 weeks; 12 weeks
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Mean Utility Ratings of Stress Reduction Text Messages
大体时间：6 weeks; 12 weeks
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Participants will rate the utility of the stress reduction text message sessions over the past six weeks on a scale of 0 (unhelpful) to 10 (very helpful).
The mean utility score from the Week 6 and Week 12 assessments was calculated using mixed effects regression, to account for variance both within and between participants.
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6 weeks; 12 weeks
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Mean Utility Ratings of Phone Check-ins
大体时间：12 weeks
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Participants will rate the utility of the phone sessions over the past six weeks on a scale of 0 (unhelpful) to 10 (very helpful).
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12 weeks
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Change in Overall Physical Activity
大体时间：Baseline, 6 weeks, 12 weeks
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ActiGraph accelerometers are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness.
In this trial, participants will wear the accelerometer for one week at baseline, 6 weeks, and 12 weeks.
We will report change from baseline to 6 weeks and 12 weeks in the average number of steps per day.
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Baseline, 6 weeks, 12 weeks
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Change in Sedentary Time
大体时间：Baseline, 6 weeks, 12 weeks
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ActiGraph accelerometers are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness.
In this trial, participants will wear the accelerometer for one week at baseline, 6 weeks, and 12 weeks.
We will report change from baseline to 6 weeks and 12 weeks in the average number of minutes of sedentary time per day.
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Baseline, 6 weeks, 12 weeks
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Change in Self-reported Physical Activity
大体时间：Baseline, 6 weeks, 12 weeks
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The International Physical Activity Questionnaire (IPAQ) is a well-validated 7-day physical activity recall assessment for physical activity.
Activity will be measured by the number of MET-minutes of moderate or greater activity per week, and change will be assessed by subtracting the baseline score from the 6- and 12-week scores.
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Baseline, 6 weeks, 12 weeks
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Change in Positive Affect (Positive Affect Items of the Positive and Negative Affect Schedule [PANAS])
大体时间：Baseline, 6 weeks, 12 weeks
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The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect (Range: 10-50).
Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks.
Higher scores indicate higher levels of positive affect.
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Baseline, 6 weeks, 12 weeks
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Change in Optimism (Life Orientation Test - Revised [LOT-R])
大体时间：Baseline, 6 weeks, 12 weeks
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The Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism (Range: 0-24).
Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks.
Higher scores indicate higher levels of optimism.
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Baseline, 6 weeks, 12 weeks
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Change in Life Satisfaction (Satisfaction With Life Scale [SWLS])
大体时间：Baseline, 6 weeks, 12 weeks
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The Satisfaction with Life Scale is a 5-item scale designed to measure global cognitive judgments of one's life satisfaction (Range: 5-35).
Higher scores reflect higher levels of life satisfaction.
Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks.
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Baseline, 6 weeks, 12 weeks
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Change in Depressive Symptoms (Hospital Anxiety and Depression Scale Depression Subscale [HADS-D])
大体时间：Baseline, 6 weeks, 12 weeks
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The Hospital Anxiety and Depression Scale depression subscale (HADS-D) will be used to measure depression.
This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21).
Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks.
Higher scores indicate higher levels of depression.
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Baseline, 6 weeks, 12 weeks
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Change in Anxiety (Hospital Anxiety and Depression Scale Anxiety Subscale [HADS-A])
大体时间：Baseline, 6 weeks, 12 weeks
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The Hospital Anxiety and Depression Scale (HADS)-anxiety subscale will be used to measure depression.
This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients (Range: 0-21).
Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks.
Higher scores indicate higher levels of anxiety.
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Baseline, 6 weeks, 12 weeks
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Change in Exercise Self-efficacy (Self-efficacy for Exercise Scale [SES])
大体时间：Baseline, 6 weeks, 12 weeks
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The Self-efficacy for Exercise Scale will be used to measure exercise self-efficacy.
This is a 9-item scale used to assess an individual's beliefs in their ability to continue exercising on a three time per week basis at moderate intensities for 20+ minutes per session in the future.
(Range: 0-90).
Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks.
Higher scores indicate higher levels of self-efficacy.
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Baseline, 6 weeks, 12 weeks
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Change in Perceived Constraints (Perceived Constraints Subscale of the MIDUS Sense of Control Measure)
大体时间：Baseline, 6 weeks, 12 weeks
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The 8-item subscale of the MIDUS Sense of Control measure will be used to measure internal locus of control - perceived constraints (Range: 8-56).
Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks.
Lower scores indicate higher levels of perceived constraints.
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Baseline, 6 weeks, 12 weeks
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Change in Personal Mastery (Personal Mastery Subscale of the MIDUS Sense of Control Measure)
大体时间：Baseline, 6 weeks, 12 weeks
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The 4-item subscale of the MIDUS Sense of Control measure will be used to measure internal locus of control - personal mastery (Range: 4-28).
Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks.
Higher scores indicate higher levels of personal mastery.
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Baseline, 6 weeks, 12 weeks
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Change in Function (General Health Questionnaire-12 [GHQ-12])
大体时间：Baseline, 6 weeks, 12 weeks
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The General Health Questionnaire-12 consists of 12 items and assesses function (Range: 0-36).
Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks.
Higher scores indicate worse functional status.
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Baseline, 6 weeks, 12 weeks
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Change in Mental Health Related Quality of Life (Medical Outcomes Study Short Form-12 Mental Component Score [SF-12 MCS])
大体时间：Baseline, 6 weeks, 12 weeks
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Mental health related quality of life will be assessed via the mental component score of the Medical Outcomes Study SF-12 (Range: 0-100).
Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks.
Higher scores indicate better health-related quality of life.
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Baseline, 6 weeks, 12 weeks
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Change in Physical Health Related Quality of Life (Medical Outcomes Study Short Form-12 Physical Component Score [SF-12 PCS])
大体时间：Baseline, 6 weeks, 12 weeks
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Physical health related quality of life will be assessed via the physical component score of the Medical Outcomes Study SF-12 (Range: 0-100).
Change will be calculated by subtracting the score at baseline from the score at 6 and 12 weeks.
Higher scores indicate better health-related quality of life.
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Baseline, 6 weeks, 12 weeks
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Change in Body Weight
大体时间：Baseline, 6 weeks, 12 weeks
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Body weight (in kilograms) will be measured by nurses.
Change will be calculated by subtracting the weight at baseline from the weight at 6 and 12 weeks.
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Baseline, 6 weeks, 12 weeks
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Change in Body Mass Index (in Kilograms Per Square Meter)
大体时间：Baseline, 6 weeks, 12 weeks
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Height and weight will be measured by nurses at baseline, 6, and 12 weeks.
Change will be calculated by subtracting the baseline value from the value at 6 and 12 weeks.
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Baseline, 6 weeks, 12 weeks
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Change in Waist Circumference (in Centimeters)
大体时间：Baseline, 6 weeks, 12 weeks
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Waist circumference will be measured by nurses at baseline, 6, and 12 weeks.
Change will be calculated by subtracting the baseline value from the value at 6 and 12 weeks.
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Baseline, 6 weeks, 12 weeks
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Change in Systolic Blood Pressure (Millimeters of Mercury)
大体时间：Baseline, 6 weeks, 12 weeks
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Blood pressure will be measured by nurses at baseline, 6, and 12 weeks.
Change will be calculated by subtracting the baseline value from the value at 6 and 12 weeks.
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Baseline, 6 weeks, 12 weeks
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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。
调查人员
- 首席研究员：Jeff C Huffman, MD、Massachusetts General Hospital
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)
2021年9月16日
初级完成 (实际的)
2024年9月16日
研究完成 (实际的)
2024年9月16日
研究注册日期
首次提交
2021年4月13日
首先提交符合 QC 标准的
2021年4月13日
首次发布 (实际的)
2021年4月19日
研究记录更新
最后更新发布 (实际的)
2026年9月2日
上次提交的符合 QC 标准的更新
2026年8月11日
最后验证
2026年7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.