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

Stanford University

Status: Enrolling

Conditions: Physical Inactivity

Treatments: Behavioral: PA Education plus human and planetary health information; Behavioral: PA Education plus Our Voice citizen science

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05566873

R01AG071490 (U.S. NIH Grant/Contract)

62096

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 232 estimated patients

Sex: Female

Ages: 66 to 105 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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232 participants in 2 patient groups

PA Education plus human and planetary health information

Active Comparator group

Description:

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).

Treatment:

Behavioral: PA Education plus human and planetary health information

PA Education plus Our Voice citizen science

Experimental group

Description:

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.

Treatment:

Behavioral: PA Education plus Our Voice citizen science