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

August 10, 2022 updated by: Abby C King, Stanford University
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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Stanford, California, United States, 94305-5705
        • Stanford Prevention Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.
• 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.
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
Moderate-to-Vigorous Physical Activity
Time Frame: 12 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2017

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

January 30, 2017

First Submitted That Met QC Criteria

January 31, 2017

First Posted (Estimate)

February 2, 2017

Study Record Updates

Last Update Posted (Actual)

August 12, 2022

Last Update Submitted That Met QC Criteria

August 10, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • R01CA211048 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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