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

Study Overview
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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.

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

Conditions
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Physical Inactivity

Intervention / Treatment
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* Behavioral: PA Education plus human and planetary health information
* Behavioral: PA Education plus Our Voice citizen science


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled in the WHISH pragmatic trial intervention arm; 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.

Ages Eligible for Study
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Minimum Age: 66 Years
Maximum Age: 105 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PA Education plus human and planetary health information<br>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). | Behavioral: PA Education plus human and planetary health information<br>* 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<br>|
| Experimental: PA Education plus Our Voice citizen science<br>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. | Behavioral: PA Education plus Our Voice citizen science<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of steps per day as measured by step counter | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weekly walking minutes | 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. | 12 months | 
| Telephone Interview for Cognitive Status-modified (TICSm) | 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. | 12 months | 
| Self-report Sedentary Behavior Questionnaire | 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. | 12 months |