Physical Activity
Conditions
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.
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.
Interventions
BEHAVIORALALED Alone Physical Activity Program
• 12-week class focused on teaching self-regulatory skills to increase regular PA
BEHAVIORALALED + 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
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors will not be told the intervention assigned of the participating housing sites
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weekly Walking Minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Physical Activity | 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. |
| Moderate-to-Vigorous Physical Activity | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were randomized in groups/clusters (affordable housing sites) to receive the assigned interventions.
Participants by arm
| Arm | Count |
|---|---|
| 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 Alone Physical Activity Program: • 12-week class focused on teaching self-regulatory skills to increase regular PA | 140 |
| 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.
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 | 160 |
| Total | 300 |
Baseline characteristics
| Characteristic | ALED + Our Voice PA Program | Total | ALED Alone Physical Activity Program |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 116 Participants | 208 Participants | 92 Participants |
| Age, Categorical Between 18 and 65 years | 44 Participants | 92 Participants | 48 Participants |
| Age, Continuous | 69.93 years STANDARD_DEVIATION 9.74 | 69.52 years STANDARD_DEVIATION 10.29 | 69.04 years STANDARD_DEVIATION 10.91 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 36 Participants | 55 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 124 Participants | 245 Participants | 121 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 27 Participants | 55 Participants | 28 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 10 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 36 Participants | 55 Participants | 19 Participants |
| Race (NIH/OMB) White | 88 Participants | 175 Participants | 87 Participants |
| Region of Enrollment United States | 160 Participants | 300 Participants | 140 Participants |
| Sex: Female, Male Female | 119 Participants | 221 Participants | 102 Participants |
| Sex: Female, Male Male | 41 Participants | 79 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 140 | 0 / 160 |
| other Total, other adverse events | 0 / 140 | 0 / 160 |
| serious Total, serious adverse events | 0 / 140 | 0 / 160 |
Outcome results
Primary
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.
Time frame: 12 months
Population: Participants who completed the protocol are included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ALED Alone Physical Activity Program | Weekly Walking Minutes | 189.5 minutes/week | Standard Deviation 227.7 |
| ALED + Our Voice PA Program | Weekly Walking Minutes | 206.7 minutes/week | Standard Deviation 198.7 |
Secondary
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.
Time frame: 12 months
Population: Participants who completed the protocol are included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ALED Alone Physical Activity Program | Moderate-to-Vigorous Physical Activity | 117.4 minutes/week | Standard Deviation 232.6 |
| ALED + Our Voice PA Program | Moderate-to-Vigorous Physical Activity | 108.8 minutes/week | Standard Deviation 139.4 |
Secondary
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.
Time frame: 12 months
Population: Participants who completed the protocol are included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ALED Alone Physical Activity Program | Total Physical Activity | 596.2 minutes/week | Standard Deviation 443.9 |
| ALED + Our Voice PA Program | Total Physical Activity | 562.0 minutes/week | Standard Deviation 389.2 |