Citizen Science to Promote Sustained Physical Activity in Low-Income Communities

• ClinicalTrials.gov Identifier: NCT03041415
• Recruitment Status: Active, not recruiting
• First Posted: February 2, 2017
• Last Update Posted: December 23, 2020
• Sponsor: Stanford University
• Information provided by (Responsible Party): Abby C King, Stanford University

Study Description

Brief Summary:

While low-income midlife and older adults are disproportionately affected by chronic diseases that can be alleviated by regular physical activity, few physical activity programs have been developed specifically with their needs in mind. Those programs that are available typically do not address the recognized local environmental factors that can impact physical activity. This research aims to evaluate the added effects on two-year physical activity levels of a novel citizen science neighborhood engagement program (called Our Voice) when combined with an evidence-based, individually-focused physical activity program (Active Living Every Day), relative to the individually-focused program alone. The programs will be delivered in affordable housing settings, and represent a potentially scalable means for promoting physical activity across broader income groups in the US.

Condition or disease	Intervention/treatment	Phase
Physical Activity	Behavioral: ALED Alone Physical Activity Program; Behavioral: ALED + Our Voice PA Program	Not Applicable

Detailed Description:

The major objective of this project is to enhance the potential scalability and sustainability of person-level physical activity (PA) interventions by leveraging the capacity of residents themselves as local data gatherers and solution generators for neighborhood environmental change. The primary aim of the group-randomized trial is to systematically compare the sustained (two-year) multi-level impacts of a lay advisor-delivered, person-level PA intervention that has demonstrated efficacy and translatability (Active Living Every Day) [ALED Alone arm], versus the ALED program in combination with a novel neighborhood-level intervention, called Our Voice [ALED+Our Voice arm]. The Our Voice program teaches residents to use a simple mobile application to individually and collectively identify neighborhood barriers to daily PA. They then convey this information to local stakeholders and decision-makers in ways that can facilitate potentially sustainable neighborhood-level improvements in support of regular PA. Up to sixteen affordable housing sites serving low-income, ethnically diverse midlife and older adults will be randomized to one of the two interventions.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: group-randomized design to either a person-level physical activity intervention alone, or the person-level physical activity intervention plus a citizen science intervention aimed at making the local neighborhood more activity-supportive.
• Masking: Single (Outcomes Assessor)
• Masking Description: Assessors will not be told the intervention assigned of the participating housing sites
• Primary Purpose: Prevention
• Official Title: Citizen Science to Promote Sustained Physical Activity in Low-Income Communities
• Actual Study Start Date: September 15, 2017
• Estimated Primary Completion Date: September 30, 2021
• Estimated Study Completion Date: September 30, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: ALED Alone Physical Activity Program; The Active Living Every Day (ALED) comprehensive 12-week PA training and support program is appropriate for delivery by trained instructors from diverse backgrounds.; Participants are taught self-regulatory skills aimed at increasing and sustaining regular physical activities such as walking.	Behavioral: ALED Alone Physical Activity Program; • 12-week class focused on teaching self-regulatory skills to increase regular PA
Experimental: ALED + Our Voice PA Program; The ALED physical activity program is combined with the Our Voice citizen science engagement program, which teaches participants how to assess the barriers and enablers of neighborhood physical activity using a simple mobile app.; Residents then share their data and build consensus around major barriers and potential solutions, which they share with local decision makers.	Behavioral: ALED + Our Voice PA Program; 12-week class focused on teaching self-regulatory skills to increase regular PA; Neighborhood assessment, consensus-building, & advocacy program in which participants are taught skills to promote neighborhood-level changes in support of regular Physical activity

Outcome Measures

Primary Outcome Measures :

1. Weekly Walking minutes [ Time Frame: 12 months ]
   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. Self-reported walking for errands is one physical activity item assessed. 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 is 0 and the maximal value is variable. (See Stewart AL, Mills KM, King AC, et al. CHAMPS Physical Activity Questionnaire for Older Adults: Outcomes for Interventions. Med Sci Sports Exerc, 33:7, 1126-1141, 2001.)

Secondary Outcome Measures :

1. Total Physical activity [ Time Frame: 12 months ]
   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. Self-reported walking for errands is one physical activity item assessed. 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 is 0 and the maximal value is variable. (See Stewart AL, Mills KM, King AC, et al. CHAMPS Physical Activity Questionnaire for Older Adults: Outcomes for Interventions. Med Sci Sports Exerc, 33:7, 1126-1141, 2001.)
2. Moderate-to-Vigorous Physical activity [ Time Frame: 24 months ]
   Self-report using the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire, supported via accelerometer (Actigraph). 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. Self-reported walking for errands is one physical activity item assessed. 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 is 0 and the maximal value is variable. (See Stewart AL, Mills KM, King AC, et al. CHAMPS Physical Activity Questionnaire for Older Adults: Outcomes for Interventions. Med Sci Sports Exerc, 33:7, 1126-1141, 2001.)

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Lives in or around a designated housing site;
• Is insufficiently physically active based on National guidelines;
• Can engage in moderate forms of PA such as walking;
• No plans to move from the area over the 2-year period;
• Willing to engage in study assessments.

Exclusion Criteria:

• Only one eligible member of a household will be enrolled;
• Medical conditions which contraindicate participation in regular, unsupervised moderate-intensity physical activity.

Contacts and Locations

Locations

United States, California

Stanford Prevention Research Center

Stanford, California, United States, 94305-5705

Sponsors and Collaborators

Stanford University

Investigators

• Principal Investigator: Abby C King, PhD; Stanford University

More Information

• Responsible Party: Abby C King, Professor of Health Research & Policy and Medicine, Stanford University
• ClinicalTrials.gov Identifier: NCT03041415
• Other Study ID Numbers: R01CA211048 ( U.S. NIH Grant/Contract )
• First Posted: February 2, 2017
• Last Update Posted: December 23, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Commensurate with current requirements, once the study data have undergone final data cleaning, analysis, and planned publication, the investigators will make the final data collected as part of the proposed research available in electronic form to researchers who request them. The investigators will request that researchers submit a data request in writing to the project principal investigator so that the requested data can be made available while protecting the confidentiality of study participants. By setting up a centralized data request process, the investigators will be able to provide requestors with information that will help to inform external research groups about duplicate data analysis activities on the part of other research groups related to the data set in question.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No