Clinical trial NCT00542360: Marketing Fall Prevention Classes to Older Adults in Faith-Based Congregations
Official title: Marketing Fall Prevention Classes to Older Adults in Faith-Based Congregations: Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Falls
Keywords: Accidental Falls
Aged
Social Marketing
Exercise
Accident Prevention
Religion
Randomized Controlled Trial
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Colorado State University
name: Colorado Department of Public Health and Environment
name: University of Utah
First posted: 2007-10-11
Enrollment: 51
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This cluster randomized trial will test whether a social marketing program implemented in churches can motivate older adults to join exercise classes, in order to improve their strength and balance and thus prevent falls.

Detailed description: Injuries from falls are a leading cause of emergency visits, hospitalizations, and deaths in older US adults, resulting in total lifetime costs of more than $19 billion in 2000. Fall injuries reduce independence and mobility, and increase disability and institutionalization. There is good evidence that community-based group exercise classes focusing on strength and balance prevent older adult falls, but uptake is limited. This study will test a new approach to promote participation in group balance-retraining exercise classes, targeting older adults in faith-based congregations. The proposal addresses national research priorities to evaluate strategies for dissemination and implementation of effective interventions to prevent falls among community-dwelling older adults. Focus groups and key informant interviews will provide research-based understanding of church members aged 60+ and those who influence them, and explore facilitators and barriers to class participation. With this formative research, a targeted social marketing program will be developed to motivate participation. Behavioral change and social marketing theories form the intervention's theoretical basis and will guide program design. The marketing program aims to increase class attractiveness, usability, and uptake by reducing barriers or costs and using incentives or other benefits to reinforce participation. Churches, representing varied denominations and communities, will be randomly allocated to intervention (marketing program implementation) or control (no program) groups. Outreach to diverse churches will ensure that materials and strategies target potentially hard-to-reach (e.g., Hispanic, rural) populations. The trial will test whether older adult members of intervention churches are more likely to join balance retraining classes. Factors that may mediate intervention effects will be examined. Secondary outcomes include baseline fall risk among class participants, assessed by physical function tests; and intensity, diffusion, message penetration and acceptability of the marketing program, and persistent facilitators and barriers to class participation, evaluated with process measures, focus groups, and structured interviews.

Eligibility criteria: Inclusion Criteria:

* Churches located in Mesa County, Colorado, that have adult members who are aged 60 and older
* Exercise class participants will include community-dwelling members of enrolled churches who are aged 60 and older, English- or Spanish-speaking, ambulatory with or without assistive devices, and cognitively able to consent and be tested.

Exclusion Criteria:

* Older adults with any medical condition that precludes participation in an exercise program, as determined by the participant or their physician, or who are not physically able to pass the Modified-Clinical Test of Sensory Interaction in Balance (M-CTSIB) at baseline

Primary outcomes:
measure: The primary endpoint is defined as attending at least one balance-retraining exercise class designed to reduce older adult falls
timeFrame: During the two-year intervention period
Secondary outcomes:
measure: Baseline fall-risk status of participants who attend at least one balance-retraining exercise class for fall prevention
timeFrame: During the two-year intervention period
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Grand Junction
country: United States
facility: Colorado Department of Public Health and Environment
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Carolyn G DiGuiseppi, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clark L, Thoreson S, Goss CW, Zimmer LM, Marosits M, DiGuiseppi C. Understanding fall meaning and context in marketing balance classes to older adults. J Appl Gerontol. 2013 Feb;32(1):96-119. doi: 10.1177/0733464811399896. Epub 2011 Apr 1.
citation: Currie DW, Thoreson SR, Clark L, Goss CW, Marosits MJ, DiGuiseppi CG. Factors Associated With Older Adults' Enrollment in Balance Classes to Prevent Falls: Case-Control Study. J Appl Gerontol. 2020 Aug;39(8):908-914. doi: 10.1177/0733464818813022. Epub 2018 Nov 18.
citation: DiGuiseppi CG, Thoreson SR, Clark L, Goss CW, Marosits MJ, Currie DW, Lezotte DC. Church-based social marketing to motivate older adults to take balance classes for fall prevention: cluster randomized controlled trial. Prev Med. 2014 Oct;67:75-81. doi: 10.1016/j.ypmed.2014.07.004. Epub 2014 Jul 12.
citation: Clark L, Thoreson S, Goss CW, Marosits M, Zimmer LM, Flattes V, DiGuiseppi C. Older Adults' Perceptions of a Church-Based Social Marketing Initiative to Prevent Falls Through Balance and Strength Classes. J Appl Gerontol. 2021 Nov;40(11):1475-1482. doi: 10.1177/0733464820984288. Epub 2021 Jan 6.