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

NCT ID: NCT05566873

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-09

Study Completion Date

2027-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Physical Inactivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Eligible individuals will be randomized to either a continuing remote educational physical activity program along with general human and planetary health information (control), or to the educational physical activity program plus a remote citizen science program aimed at physical and social environmental barriers to walking and other physical activities.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Outcome assessors will be masked to condition assignment.

Study Groups

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PA Education plus human and planetary health information

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).

Group Type ACTIVE_COMPARATOR

PA Education plus human and planetary health information

Intervention Type 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

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.

Group Type EXPERIMENTAL

PA Education plus Our Voice citizen science

Intervention Type 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

Interventions

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PA Education plus human and planetary health information

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

Intervention Type BEHAVIORAL

PA Education plus Our Voice citizen science

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

66 Years

Maximum Eligible Age

105 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Abby C King

Professor of Epidemiology and Population Health and of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abby C King, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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R01AG071490

Identifier Type: NIH

Identifier Source: secondary_id

View Link

62096

Identifier Type: -

Identifier Source: org_study_id

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