NCT03041415

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

September 15, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
7 months until next milestone

Results Posted

Study results publicly available

August 12, 2022

Completed
Last Updated

August 12, 2022

Status Verified

April 1, 2022

Enrollment Period

4.3 years

First QC Date

January 30, 2017

Results QC Date

April 21, 2022

Last Update Submit

August 10, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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. 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 Outcomes (2)

  • Total Physical Activity

    12 months

  • Moderate-to-Vigorous Physical Activity

    12 months

Study Arms (2)

ALED Alone Physical Activity Program

ACTIVE COMPARATOR

* 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

ALED + Our Voice PA Program

EXPERIMENTAL

* 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

Interventions

• 12-week class focused on teaching self-regulatory skills to increase regular PA

ALED Alone Physical Activity 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

ALED + Our Voice PA Program

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Prevention Research Center

Stanford, California, 94305-5705, United States

Location

Related Publications (2)

  • Stewart AL, Mills KM, King AC, Haskell WL, Gillis D, Ritter PL. CHAMPS physical activity questionnaire for older adults: outcomes for interventions. Med Sci Sports Exerc. 2001 Jul;33(7):1126-41. doi: 10.1097/00005768-200107000-00010.

    PMID: 11445760BACKGROUND
  • King AC, Campero MI, Garcia D, Blanco-Velazquez I, Banchoff A, Fierros F, Escobar M, Cortes AL, Sheats JL, Hua J, Chazaro A, Done M, Espinosa PR, Vuong D, Ahn DK. Testing the effectiveness of community-engaged citizen science to promote physical activity, foster healthier neighborhood environments, and advance health equity in vulnerable communities: The Steps for Change randomized controlled trial design and methods. Contemp Clin Trials. 2021 Sep;108:106526. doi: 10.1016/j.cct.2021.106526. Epub 2021 Aug 8.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Principal Investigator
Organization
Stanford University

Study Officials

  • Abby C King, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessors will not be told the intervention assigned of the participating housing sites
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Health Research & Policy and Medicine

Study Record Dates

First Submitted

January 30, 2017

First Posted

February 2, 2017

Study Start

September 15, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

August 12, 2022

Results First Posted

August 12, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

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.

Locations