- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03041415
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
Status
Completed
Conditions
Intervention / Treatment
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
|
• 12-week class focused on teaching self-regulatory skills to increase regular PA
|
|
Experimental: ALED + Our Voice PA Program
|
|
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.
Sponsor
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.
General Publications
- 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.
- 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.
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.
Clinical Trials on Physical Activity
-
Muğla Sıtkı Koçman UniversityEge UniversityCompletedPhysical Activity | Physical Activity Behavior | Physical Activity LevelsTurkey
-
Istinye UniversityCompletedPhysical Activity | Youth | Physical Activity Barriers | Physical Activity FacilitatorsTurkey
-
University of ManitobaResearch ManitobaCompletedPhysical Activity | Physical Activity Self-Definition
-
Universidad Pedagogica Nacional, ColombiaEnrolling by invitationPhysical Activity | Running | Running Performance | Running Endurance | Physical Activity in Adults | Physical Activity IntensityColombia
-
Istanbul Kültür UniversityWithdrawnPhysical Activity Level | Physical Activity Awareness
-
Universidade do PortoActive, not recruitingPhysical Activity | Physical Fitness | Well BeingPortugal
-
Odense University HospitalUniversity of Southern DenmarkRecruitingQuality of Life | Physical Activity | Physical Disability | Physical Function | ParticipationDenmark
-
Firat UniversityNot yet recruitingUniversity Students | Physical Activity Level | Postural Awareness | Physical Activity AttitudeTurkey
-
Georgetown UniversityUniversity of PennsylvaniaCompletedPhysical Activity | Motor ActivityUnited States
-
Pham Ngoc Thach University of MedicineCompletedModerate Physical Activity (MPA) | Vigorous Physical Activity (VPA) | Moderate to Vigorous Physical Activity (MVPA) | Total of Sleep Time (TST)Vietnam
Clinical Trials on ALED Alone Physical Activity Program
-
Northwestern UniversityCompletedSedentary BehaviorUnited States
-
Universidad Santo TomasEmory University; Universidad Pública de Navarra; Universidad de Granada; University... and other collaboratorsCompletedObesity | Lipid Metabolism Disorders | Mental Health Wellness 1 | Body Composition, Beneficial | Metabolic Syndrome X
-
University Hospital, Clermont-FerrandRecruiting
-
Case Western Reserve UniversityNational Multiple Sclerosis SocietyCompletedMultiple SclerosisUnited States
-
Assistance Publique Hopitaux De MarseilleRecruiting
-
University of Illinois at Urbana-ChampaignUniversity of ArizonaCompleted
-
Fundacion para la Investigacion y Formacion en...CompletedImpaired CognitionSpain
-
Centre Hospitalier Universitaire de NiceNot yet recruiting
-
ElsanNot yet recruitingIndividualised Physical Activity Program | Coronary Patient
-
University Hospital of FerraraUniversità degli Studi di FerraraCompletedChronic Kidney Disease Stage 5 on DialysisItaly