Clinical trial NCT05566873: Testing Multi-Level Remote Physical Activity Interventions in a National Sample of Older Women: The WHISH EnCore Trial
Official title: Testing Multi-Level Remote Physical Activity Interventions in a National Sample of Older Women: The WHISH EnCore Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Inactivity
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-10-04
Enrollment: 232
Sex: FEMALE
Minimum age (years): 66
Maximum age (years): 105
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean number of steps per day as measured by step counter
timeFrame: 12 months
Secondary outcomes:
measure: Weekly walking minutes
timeFrame: 12 months
measure: Telephone Interview for Cognitive Status-modified (TICSm)
timeFrame: 12 months
measure: Self-report Sedentary Behavior Questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Abby C King, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: