- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00542360
Marketing Fall Prevention Classes to Older Adults in Faith-Based Congregations
November 29, 2018 updated by: University of Colorado, Denver
Marketing Fall Prevention Classes to Older Adults in Faith-Based Congregations: Cluster Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Colorado
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Denver, Colorado, United States, 80262
- University of Colorado Health Sciences Center
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Grand Junction, Colorado, United States, 81501
- Colorado Department of Public Health and Environment
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Social marketing program
Behavioral: Social 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.
|
No Intervention: Control
Control: No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary endpoint is defined as attending at least one balance-retraining exercise class designed to reduce older adult falls
Time Frame: During the two-year intervention period
|
During the two-year intervention period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Baseline fall-risk status of participants who attend at least one balance-retraining exercise class for fall prevention
Time Frame: During the two-year intervention period
|
During the two-year intervention period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Carolyn G DiGuiseppi, MD, MPH, PhD, University of Colorado, Denver
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
October 9, 2007
First Submitted That Met QC Criteria
October 9, 2007
First Posted (Estimate)
October 11, 2007
Study Record Updates
Last Update Posted (Actual)
December 3, 2018
Last Update Submitted That Met QC Criteria
November 29, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 06-0636
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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