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This is a 12-month multi-level behavioral cluster randomized trial testing a church-based intervention to improve physical function (PF) in Americans with PF limitations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Keep it Movin' | Experimental |
| |
| Go 4 Life Self Guided Education | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Keep it Movin' | Behavioral | Individual participants in churches randomized to the intervention arm will participate in the Keep it Movin' multi-component PA education program, as well as be encouraged by their church and study interventionist to participate in the church-wide walking program. Individuals enrolled in Keep It Movin' will attend weekly 90-minute sessions for 24 weeks. All sessions will include the structured physical activity component from the LIFE study intervention, with the following components, which were added to address needs of the target community: functional education, social support and problem-solving. To increase the functional gains seen in the LIFE pilot study and add content addressing self-management and PA with multiple chronic conditions (MCCs), the number of sessions in the proposed trial has been increased from 16 to 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Function | Objective physical function will be measured using the Short Physical Performance Battery (SPPB) an instrument commonly used to measure physical performance within the aging population. | Measured at baseline and 6 months and 12 months after start of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Activity | Objective physical activity (i.e., time spent in moderate and vigorous physical activity) will be collected via a wrist worn accelerometer (ActiGraph GT9X Link activity monitor) collected over 4-7 days. The ActiGraph GT9X Link provides physical activity data including raw acceleration, energy expenditure, steps taken, physical activity intensity, activity and sedentary bouts, and heart rate intervals. |
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Inclusion Criteria:
Churches (Community-level):
Participants (Individual-level):
Exclusion Criteria:
Participants (Individual-level):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth M Lynch, PhD | Contact | 3125632254 | elizabeth_lynch@rush.edu | |
| Yolanda Cartwright, PhD, RD | Contact | 3129429697 | yolanda_cartwright@rush.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60422 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39542132 | Derived | Lange-Maia BS, Deckard A, Dugan SA, Cartwright Y, Epting SM, Jenkins L, Suzuki S, Press VG, Rothschild SK, Lynch EB. Keep it Movin': Design and methods of a church-based physical activity program to improve physical function among midlife and older black adults. Contemp Clin Trials. 2024 Dec;147:107742. doi: 10.1016/j.cct.2024.107742. Epub 2024 Nov 13. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 13, 2023 | Oct 3, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000071069 | Multiple Chronic Conditions |
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The proposed study is a 12-month multi-level behavioral cluster randomized trial testing a church-based intervention to improve physical function (PF) in Americans with PF limitations (short physical performance battery [SPPB]<10). Churches in both arms (12 in each) will receive a virtual church-wide walking program which will be open to all church members, providing support for physical activity (PA) at interpersonal and community-levels. Churches will be randomized to either the church-wide walking program plus Keep it Movin' (KIM) intervention (intervention arm) or the church-wide walking program plus education (control arm). Using an active comparator will allow the assessment of whether the KIM intervention is more effective than a church-wide walking program along with improving PA individuals with PF limitations.
Individuals who meet study inclusion criteria, including limited PF and at least two chronic conditions will be recruited from churches in both arms.
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| Go 4 Life Self Guided Education | Behavioral | Individual participants in churches randomized to the comparator arm will receive the church-wide walking program and the Go4Life Your Everyday Guide to Exercise and Physical Activity which was developed by the National Institutes of Health National Institute on Aging to promote physical activity in older adults. This includes an evidence-based exercise guide and motivational tips to help older adults start and sustain an exercise program. The Go4Life guide will add individual level education and encouragement to the interpersonal and community levels of intervention provided by the church-wide walking program. |
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| Measured at baseline and 6 months and 12 months after start of the intervention |
| Change in Self-Reported Physical Activity | Self reported physical activity will be evaluated using the Community Healthy Activities Model Program For Seniors (CHAMPS) questionnaire. The CHAMPS physical activity questionnaire is designed to promote physical activity in seniors. The CHAMPS tool is a 41-item questionnaire that asks about the length of time spent doing certain activities (less than an hour to 9 or more hours) in the past 4 weeks. | Measured at baseline and 6 months and 12 months after start of the intervention |
| Change in Self-Reported Physical Function | Self-report of physical function will be evaluated by the Functional Status Questionnaire. The survey is a geriatric tool designed for participants to self-report capturing the participants' physical, psychological, social and role functions. | Measured at baseline and 6 months and 12 months after start of the intervention |
| Change in Social Support | Social support for exercise will be measured using the Social Support & Exercise Survey Self-efficacy questionnaire. | Measured at baseline and 6 months and 12 months after start of the intervention |
| Change in Quality of Life | Quality of life will be measured using EuroQual (EQ-5D-5L) questionnaire. The measure evaluates the participant's perception of their "health today" with respect to mobility, self-care, usual activities, pain/discomfort, and anxiety depression. the items are evaluated on a 5-point scale ranging from "no problem" in the area to "extreme problem" in the area. | Measured at baseline and 6 months and 12 months after start of the intervention |
| Change in Self-efficacy | Self efficacy will be measured using The Self-Efficacy for Exercise Scale consisting of 9 hypothetical situations like weather, boredom that could impact a person's ability to exercise. | Measured at baseline and 6 months and 12 months after start of the intervention |