Marketing Fall Prevention Classes to Older Adults in Faith-Based Congregations
| Tracking Information | |||||
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| First Received Date ICMJE | October 9, 2007 | ||||
| Last Updated Date | May 8, 2013 | ||||
| Start Date ICMJE | October 2007 | ||||
| Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| 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 ] [ Designated as safety issue: No ] | ||||
| Original 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 ] | ||||
| Change History | Complete list of historical versions of study NCT00542360 on ClinicalTrials.gov Archive Site | ||||
| 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 ] [ Designated as safety issue: No ] | ||||
| Original 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 ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| 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 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. |
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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. 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Accidental Falls | ||||
| Intervention ICMJE | 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. |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 51 | ||||
| Completion Date | January 2012 | ||||
| Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 60 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00542360 | ||||
| Other Study ID Numbers ICMJE | 06-0636 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University of Colorado, Denver | ||||
| Study Sponsor ICMJE | University of Colorado, Denver | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Colorado, Denver | ||||
| Verification Date | May 2013 | ||||
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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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