Church-based Intervention to Improve Physical Function

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rush University Medical Center
Study ID
NCT05345041
Status
Recruiting
Apply to this trial

Conditions

  • Multiple Chronic Conditions
  • Physical Function

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Sep 21, 2023
Status verified
Apr 2025
Primary completion
Mar 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Keep it Movin'
  • Active Comparator: Go 4 Life Self Guided Education

Primary Outcome Measure

Change in Physical Function [ Time Frame: Measured at baseline and 6 months and 12 months after start of the intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60422
Elizabeth Lynch, PhD
[email protected]
312-563-2254
Yolanda Cartwright, PhD, RD
[email protected]
312-942-9697
Elizabeth Lynch, PhD (PRINCIPAL_INVESTIGATOR)
Steve Rothschild, MD (PRINCIPAL_INVESTIGATOR)
Sheila Dugan, MD (SUB_INVESTIGATOR)
Brittany Lange-Maia, PhD (SUB_INVESTIGATOR)
Steve Epting, MA (SUB_INVESTIGATOR)
Sumihirio Suzuki, PhD (SUB_INVESTIGATOR)
Yolanda Cartwright, PhD, RD (SUB_INVESTIGATOR)

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Rush University Medical Center· Chicago, IL

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