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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 9, 2007 | ||||
| Last Updated Date | October 9, 2007 | ||||
| Start Date ICMJE | October 2007 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Marketing Fall Prevention Classes to Older Adults in Faith-Based Congregations | ||||
| Official Title ICMJE | Marketing Fall Prevention Classes to Older Adults in Faith-Based Congregations: Cluster Randomized Controlled Trial | ||||
| Brief Summary | This study will test whether a social marketing program implemented in churches and other faith-based congregations can motivate older adults to join exercise classes, in order to improve their strength and balance and thus prevent falls. |
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| 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 (FBCs). 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 FBC 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. FBCs, representing varied denominations and communities, will be randomly allocated to intervention (marketing program implementation) or control (no program) groups. Outreach to diverse FBCs will ensure that materials and strategies target potentially hard-to-reach (e.g., Hispanic, rural) populations. The trial will test whether seniors from intervention FBCs 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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Accidental Falls | ||||
| Intervention ICMJE | Behavioral: Marketing program to motivate exercise class participation | ||||
| Study Arms / Comparison Groups | Experimental: Intervention | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 470 | ||||
| Estimated Completion Date | February 2012 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 60 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00542360 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | R49/CCR811509 | ||||
| Study Sponsor ICMJE | University of Colorado at Denver and Health Sciences Center | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Colorado at Denver and Health Sciences Center | ||||
| Verification Date | October 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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