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临床试验/NCT03405103
NCT03405103已完成不适用

Efficacy of m-Health Self-Management Intervention

University of Wisconsin, Milwaukee0 个研究点目标入组 290 人开始时间: 2012年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
290
主要终点
Change in Bone Mineral Density

研究概览

简要总结

The vast majority of people want to be healthy and often make a change to be healthier. Change that is begun is seldom maintained. Osteoporosis is an example of one condition where people are encouraged to regularly engage in preventative health behaviors. This is a study testing a new approach to helping women engage in osteoporosis health behaviors. This new approach includes beliefs, self-regulating skills and abilities, and social facilitation delivered via a cell phone app. If effective, this approach could be tested with other health behaviors.

详细描述

The goal of this project is to test the efficacy a theory based, patient-centered, dynamically tailored intervention delivered via a cell phone app. The four aims of this project are to: 1) Test the efficacy of the intervention to improve long term maintenance of osteoporosis prevention health behaviors in midlife women, 2) evaluate moderators and mediators of long-term engagement in health behaviors, 3) describe processes of health behavior change and evaluate differences within and between subjects using Ecological Momentary Assessments (EMA) as a complement to traditional measures and 4) evaluate the utility of The Individual and Family Self-Management Theory to explain health behavior change. In the U.S., over 35 million women either have or are at high risk for osteoporosis at an anticipated cost of greater than $25 billion by 2025. Osteoporosis affects 1 out of 2 White women, is rapidly growing among populations of color and causes high chronic disease burden worldwide. Less than 6% of women regularly engage in the basic health promotion behaviors. The vast disparity between the high prevalence of osteoporosis and the low number of people who engage in preventative care highlights this condition as one of many striking examples of the crucial role behavior change could play in improving health and decreasing health care costs. New knowledge suggests enhancing knowledge and beliefs, self-regulation skill and abilities, and social facilitation leads to self-management and improved health outcomes. It is hypothesized that the more an intervention integrates health behavior change processes into daily activities the more likely it is to increases one's capacity to self-manage. The work proposed is significant because it focuses on the serious and prevalent condition of osteoporosis; tests the application of a theory based, patient-centered, dynamic intervention designed to improve outcomes; and, decisively bundles new knowledge about methodologies, intervention processes, and delivery media to provide a cohesive foundation for intervention development and testing. Innovative aspects include use of EMAs as a complementary approach to providing feedback and measuring behavior change processes; testing a newly identified health behavior change theory; and development and evaluation of a cell phone app, one type of m-Health. Through technological advances we now have the capacity to integrate health behavior change processes into every day activities via a cell phone app but the effectiveness of the app to change health behaviors has not been demonstrated empirically. A three-group randomized controlled longitudinal design with data collected at baseline, 3, 6, 9, and 12 months will be used. A convenience sample of 288 (96 per group) community dwelling women will be enrolled. Outcomes will be evaluated with self-report, behavioral performance, and bio-behavioral measures, including DXA and vitamin D. The expected outcomes are achievement of an increase in women's initiation and long term maintenance of osteoporosis self-management behaviors and stabilization of bone mineral density.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • healthy (able to participate in physical activity, not receiving medical care for chronic condition, not taking medications that would affect bone, greater than 5 years post treatment for cancer) not pregnant or lactating speaks and reads English consumes at least 200 mg less recommended amount of dietary calcium

排除标准

  • diagnosis of osteoporosis, history of fragile fracture, does not engage in vigorous activity more than 2 times a week

研究组 & 干预措施

Striving

Experimental

Striving vs Boning-up & Personal Choice

干预措施: Striving (Behavioral)

Boning-up Standard Education

Active Comparator

Boning-up vs Striving and Personal Choice

干预措施: Boning-Up (Behavioral)

Personal Choice

Sham Comparator

Personal Choice vs Striving & Boning-up

干预措施: Personal Choice (Behavioral)

结局指标

主要结局

Change in Bone Mineral Density

时间窗: Baseline and 12 months

Bone Mineral Density obtained via Dual Energy x-ray absorptiometry

次要结局

  • Stand Test(Baseline and 12 months)
  • Functional Movement Screen (adaptation)(Baseline and 12 months)
  • 6-minute walk test(Baseline and 12 months)
  • Engagement in Self-regulation processes: "What are you doing today"/ DOTs(Over 12 months a total of 284 text message were sent to each participant via newly designed app. Score included frequency of behavior and self-regulation process for 4 week periods over 12 months.)
  • vitamin D(Baseline and 12 months)
  • Calcium Focused Food Diary(Baseline, 3, 6, 9, and 12 months)
  • Physical Activity Questionnaire (IPAQ)- Short Form: Measure of time and intensity of persons engagement in physical activity.(Baseline, 3, 6, 9, and 12 months)
  • Balance(Baseline and 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Polly Ryan, PhD, RN, FAAN

Researcher

University of Wisconsin, Milwaukee

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