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

NCT05566873 | Active Not Recruiting

• 2 other identifiers: 62096R01AG071490
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Inactivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Weekly walking minutes

  12 months

• Telephone Interview for Cognitive Status-modified (TICSm)

  12 months

• Self-report Sedentary Behavior Questionnaire

  12 months

Study Arms (2)

PA Education plus human and planetary health information

ACTIVE COMPARATOR

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

PA Education plus Our Voice citizen science

EXPERIMENTAL

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

Interventions

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 human and planetary health information

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

PA Education plus Our Voice citizen science

Eligibility Criteria

• Age: 66 Years - 105 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Abby C King, Ph.D

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be masked to condition assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Epidemiology and Population Health and of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 4, 2022
• Study Start: January 9, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: We will aim to make the data and referenced resource from a publication available by the on-line publication date.
• Access Criteria: See above plan description.

Locations

US (1)