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临床试验/NCT03558828
NCT03558828已完成不适用

Testing Adaptive Interventions to Improve Physical Activity for Sedentary Women

Rush University Medical Center2 个研究点 分布在 1 个国家目标入组 301 人开始时间: 2018年8月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
301
试验地点
2
主要终点
Physical Activity-Steps

研究概览

简要总结

This study employs a Sequential Multiple Assignment Randomized Trial (SMART) and aims to determine the most effective adaptive intervention combining four efficacious treatments (enhanced physical activity monitor, motivational text messages, motivational personal calls, group meetings) to increase physical activity and improve cardiovascular health among sedentary employed women.

详细描述

The long-term goal of this research program is to develop cost-effective strategies to increase moderate- intensity physical activity among sedentary women. Fewer than half of U.S. women meet recommendations for moderate-intensity physical activity, and thereby are at increased risk for cardiovascular disease. When provided a physical activity program, between 25-60% of women either fail to adopt it or fail to adhere after six months. Physical activity health benefits are further negatively impacted by the fact that sedentary behavior at many worksites exacerbates low physical activity. Among efficacious treatments for increasing physical activity for women, four have had promising results: (1) enhanced physical activity monitor treatment (PA monitor with goal setting and a physical activity prescription); (2) motivational text messages; (3) motivational personal calls; and (4) group meetings. While each of these treatments has proven efficacy, they differ on resource use and cost, and there is heterogeneity in response. When treatments have heterogeneity of response, adaptive interventions can help close that gap. Adaptive interventions start with an initial treatment and then transition to an augmented treatment for non-responders. This study aims to determine the most effective adaptive intervention combining four efficacious treatments (enhanced physical activity monitor, motivational text messages, motivational personal calls, group meetings) to increase physical activity (step counts per day, minutes moderate/vigorous physical activity per week) and improve cardiovascular health (aerobic fitness, body composition) among sedentary employed women. The investigators will also assess treatment effects on intervention targets (physical activity benefits, physical activity barriers, physical activity self-efficacy, and social support). A Sequential Multiple Assignment Randomized Trial (SMART) design will address the following aims: 1) Among non-responders to the initial treatments (enhanced physical activity monitor and enhanced physical activity monitor+ motivational text messages), compare the two augmented treatments (motivational personal calls and group meetings); 2a) Compare the two initial treatments and; 2b) Compare the four adaptive interventions embedded in the SMART on physical activity and cardiovascular health; 3) Identify mediators and moderators of the initial and augmented treatments on physical activity and cardiovascular health; 4) Compare the cost-effectiveness of the four adaptive interventions from the societal perspective which includes both program costs and participant costs. The investigators will recruit 312 sedentary women, aged 18 to 70, who are employed at a large urban academic medical center. Data will be collected on physical activity (self- report, device), cardiovascular health, physical activity benefits, physical activity barriers, physical activity self-efficacy, social support, and program and participant costs. Data will be collected at baseline, weeks 9-10 (when response to initial treatment is assessed), weeks 35-36, and weeks 51-52. The investigators expect to identify an optimal adaptive intervention for improving physical activity and cardiovascular health that minimizes costs and burden to women who respond to less intensive treatments, while maximizing benefits for those who need a more intensive approach.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female employee at study site
  • Aged 18 to 70
  • Able to speak/read English
  • Owns a smartphone with text messaging capability
  • Willing to receive text messages at the proposed pace
  • We will include participants who have Type 1 diabetes, or Type 2 diabetes with an A1C ≥ 9.0%, or have an A1C of ≥ 6.5% without a prior diabetes diagnosis, only if they have been given clearance by their health care provider
  • Without a disability that inhibits walking as determined by the PAR-Q & You (Physical Activity Readiness Questionnaire)
  • Exclusion Criteria
  • Major signs/symptoms of pulmonary or cardiovascular disease
  • Systolic BP ≥ 160 and/or diastolic BP ≥ 100
  • Sufficiently or overly active, as determined by a physical activity monitor worn for one week, indicating averaging ≥ 7,500 steps per day ("somewhat active")

排除标准

  • 未提供

结局指标

主要结局

Physical Activity-Steps

时间窗: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for steps.

Physical activity-Steps: Average daily steps were measured with ActiGraph worn on the right hip during waking hours for one week.

Physical Activity- Moderate to Vigorous Physical Activity (MVPA)

时间窗: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for MVPA.

Average daily minutes of Moderate to Vigorous Physical Activity (MVPA) were measured with ActiGraph worn on the right hip during waking hours for one week.

次要结局

  • Cardiovascular Health (3)(Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for waist measurement.)
  • Cardiovascular Health (2)(Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for BMI.)
  • Cardiovascular Health (1)(Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for aerobic fitness.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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