跳至主要内容
临床试验/NCT05566873
NCT05566873进行中(未招募)不适用

Testing Multi-Level Remote Physical Activity Interventions in a National Sample of Older Women: The WHISH EnCore Trial

Stanford University1 个研究点 分布在 1 个国家目标入组 232 人开始时间: 2024年1月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
232
试验地点
1
主要终点
Mean number of steps per day as measured by step counter

研究概览

简要总结

While older women are disproportionately affected by chronic diseases and conditions associated with aging, including both physical and cognitive impairments, that can be alleviated or delayed by regular physical activity, few physical activity programs have been developed specifically with their needs in mind. This research aims to evaluate, in insufficiently active older women from the national WHISH pragmatic trial, the effects of a technology-driven "citizen science" approach to environmental physical activity barriers called Our Voice plus the ongoing "light-touch" remote physical activity educational program, compared to the "light-touch" remote physical activity educational program plus a control educational intervention that creates awareness around human and planetary health. This study will add important information on the benefits and trade-offs of combining these remotely delivered and practical behavioral health approaches to promote physical and cognitive health for the fast-expanding demographic group of U.S. older women.

详细描述

Older women are disproportionately impacted by a range of chronic diseases and conditions, such as cognitive impairments, that can be alleviated by regular physical activity (PA), including walking; yet they are the most inactive segment of the US population. This study's primary aim is to enhance the efficacy of a "light-touch", remotely delivered PA educational intervention for older women by testing the added impacts of an innovative, remotely delivered citizen science program to identify and address local environmental barriers to walking and other PA, called Our Voice (OV). The "light-touch" PA educational program (Encore) has been delivered since 2015 to >23,000 women >70 years that have been participating in the U.S.-wide Women's Health Initiative Strong and Healthy (WHISH) pragmatic PA trial. The study's hypothesis is that women receiving Encore+OV will show higher 12-month PA levels than women receiving Encore plus the control educational program. Additional questions include changes in cognitive function and sedentary behavior and exploring the relative costs of the two programs for PA change.

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
Single (Outcomes Assessor)

盲法说明

Outcome assessors will be masked to condition assignment.

入排标准

年龄范围
66 Years 至 105 Years(Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Is insufficiently physically active based on National Guidelines;
  • Can engage in moderate forms of walking in and around their neighborhoods;
  • Owns and can use a smartphone;
  • Willing to wear the study pedometer;
  • No plans to move from the area over the 1 year study period;
  • Willing to be randomized and engage in study assessments;

排除标准

  • Not currently living in a nursing home or with a dementia diagnosis or other medical condition that would preclude moderate forms of physical activity outside the home or study participation.

研究组 & 干预措施

PA Education plus human and planetary health information

Active Comparator

Participants will continue to receive the remote "light touch" physical activity education program that they have been receiving for the past several years along with additional remote health education information to control for nonspecific factors (staff attention, participant time).

干预措施: PA Education plus human and planetary health information (Behavioral)

PA Education plus Our Voice citizen science

Experimental

Participants will receive the remote "light touch" physical activity education program in combination with the remote Our Voice citizen science program aimed at identifying and addressing physical and social environmental barriers to and enablers of regular physical activity.

干预措施: PA Education plus Our Voice citizen science (Behavioral)

结局指标

主要结局

Mean number of steps per day as measured by step counter

时间窗: 12 months

Participants will wear an Accusplit pedometer to record on the WHISH study website data entry tracking system their number of steps/day. Higher numbers of steps per day is considered a better outcome.

次要结局

  • Weekly walking minutes(12 months)
  • Telephone Interview for Cognitive Status-modified (TICSm)(12 months)
  • Self-report Sedentary Behavior Questionnaire(12 months)

研究者

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

Abby C King

Professor of Epidemiology and Population Health and of Medicine

Stanford University

研究点 (1)

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