Physical ActivityNCT03041415
Citizen Science to Promote Sustained Physical Activity in Low-Income Communities
A study testing ALED Alone Physical Activity Program and ALED + Our Voice PA Program in people with Physical Activity, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- ALED Alone Physical Activity Program and ALED + Our Voice PA Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Only one eligible member of a household will be enrolled;
- Medical conditions which contraindicate participation in regular, unsupervised moderate-intensity physical activity.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Prevention Research Center
Stanford, California, 94305-5705
About this study
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.
Read the 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.
- Conditions
- Physical Activity
- Being tested
- ALED Alone Physical Activity Program, ALED + Our Voice PA Program
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALED Alone Physical Activity ProgramBehavioural
- 12-week class focused on teaching self-regulatory skills to increase regular PA
ALED + Our Voice PA ProgramBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: ALED + Our Voice PA Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
Total Physical Activity
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.
Measured: 12 months
Moderate-to-Vigorous Physical Activity
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start15 Sep 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abby C King, Stanford University
- Investigators
- Abby C King, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041415
- Sponsor's protocol ID
- R01CA211048
- Status last verified
- Apr 2022
- First submitted
- 30 Jan 2017
- Last updated
- 12 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 11445760King 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.
PubMed 34371162
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Citizen Science to Promote Sustained Physical Activity in Low-Income Communities
- ClinicalTrials.gov ID
- NCT03041415
- Acronym / sponsor ID
- R01CA211048
- Conditions
- Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Posted 12 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ALED Alone Physical Activity Program | Active comparator | Behavioral: 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. |
| ALED + Our Voice PA Program | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Only one eligible member of a household will be enrolled;
- Medical conditions which contraindicate participation in regular, unsupervised moderate-intensity physical activity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALED Alone Physical Activity Program• 12-week class focused on teaching self-regulatory skills to increase regular PA | Behavioural | ALED Alone Physical Activity Program |
| 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 | Behavioural | ALED + Our Voice PA Program |
Primary outcome
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.
2 secondary outcomes
Total Physical Activity
Time frame: 12 months
Moderate-to-Vigorous Physical Activity
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11445760Stewart 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.
- Derived from this study: PubMed 34371162King 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abby C King, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALED Alone Physical Activity Program and ALED + Our Voice PA Program in people with Physical Activity, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly Walking Minutes (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03041415, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022.