Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05566873

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Physical Inactivity Behavior Sedentary Behavior

Age range

66 year–105 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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.

Treatment and study plan

PA Education plus human and planetary health information

Behavioral

One year of continuing person-level physical activity promotion and health-related information delivered primarily by mail, email, and through online scientific video presentations and exploration of freely available citizen science mobile applications

PA Education plus Our Voice citizen science

Behavioral

One year of continuing person-level physical activity promotion and health-related information delivered primarily by mail and email, plus participatory citizen science activities involving neighborhood audits of the walking environment using a mobile app and remote group discussion and problem-solving around physical activity barriers

Primary outcomes

  1. Mean number of steps per day as measured by step counter

    Time frame: 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.

Secondary outcomes

  1. Weekly walking minutes

    Time frame: 12 months

    Self-report using the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire. CHAMPS is a self-report physical activity questionnaire that assesses weekly frequency and duration of various activities typically undertaken by midlife and older adults over the prior 4-week period (for example, self-reported walking for errands, for leisure, up hills, brisk walking). The measure has been shown to have good test-retest reliability (stability) and construct and concurrent validity, and has been shown to be sensitive to change in a variety of adult populations. It has seven frequency categories (from less than 1 hour a week to 9 or more hours per week). The minimum value (walking minutes) is 0 and there is no set maximum value. The national recommendation is for 150 minutes per week. Higher numbers on this measure are considered a better outcome.

  2. Telephone Interview for Cognitive Status-modified (TICSm)

    Time frame: 12 months

    The 16-item (50-point) TICSm, which is the most widely used telephone cognitive assessment tools for older populations, and has been shown to have excellent validity and reliability in diverse groups of older adults. It correlates well with comprehensive neuropsychological assessments, is less constrained by ceiling effects than the Mini Mental State Examination (MMSE), and has been shown to be sensitive to change. A higher score on this measure is considered a better outcome.

  3. Self-report Sedentary Behavior Questionnaire

    Time frame: 12 months

    This 7-item 1-week recall questionnaire has been shown to have good test-retest reliability and validity, and has been shown to be sensitive to change with intervention. A higher score is considered a worse outcome.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: WHISH EnCore

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 4, 2022
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.