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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00542360
Other study ID # 06-0636
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2007
Est. completion date January 2012

Study information

Verified date November 2018
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date January 2012
Est. primary completion date September 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Marketing program to motivate exercise class participation
Using qualitative research methods, a targeted social marketing program, including a 'marketing toolkit,' was developed to motivate participation in exercise classes by older adult members of churches. The Health Belief and Transtheoretical Models formed the theoretical basis for the social marketing planning process and guided program design. The marketing program aimed to increase exercise class attractiveness, usability, and uptake by reducing barriers and costs, and using messaging about benefits and enhanced convenience to motivate participation. The intervention was implemented through churches.

Locations

Country Name City State
United States University of Colorado Health Sciences Center Denver Colorado
United States Colorado Department of Public Health and Environment Grand Junction Colorado

Sponsors (5)

Lead Sponsor Collaborator
University of Colorado, Denver Centers for Disease Control and Prevention, Colorado Department of Public Health and Environment, Colorado State University, University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. 2018 Nov 18:733464818813022. doi: 10.1177/0733464818813022. [Epub ahead of print] — View 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The primary endpoint is defined as attending at least one balance-retraining exercise class designed to reduce older adult falls During the two-year intervention period
Secondary Baseline fall-risk status of participants who attend at least one balance-retraining exercise class for fall prevention During the two-year intervention period
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