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| Tracking Information | |||||
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| First Received Date ICMJE | August 19, 2000 | ||||
| Last Updated Date | July 24, 2009 | ||||
| Start Date ICMJE | April 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00006181 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Promoting Healthy Lifestyles | ||||
| Official Title ICMJE | PHLAME: Promoting Healthy Lifestyles: Alternative Models' Effects | ||||
| Brief Summary | Promoting Healthy Lifestyles: Alternative Models' Effects (PHLAME) is a research study to evaluate and compare two ways to promote healthy behaviors, (regular physical activity, less than 30% calories from fat, 5 or more servings of fruits plus vegetables each day and maintain a healthy weight). Unhealthy nutrition practices and sedentary (inactive) lifestyles are the two most common harmful behaviors in the United States. Our two health promotion methods are 1) a team-based approach and 2) a one-on-one approach involving meetings with a health counselor. A third group only receives the same evaluation and their results and is the control group. Study participants are firefighters from 36 fire stations in Oregon and Washington. The goals of the study are increased physical activity and fitness, improved nutrition, and improved energy balance (reduced body fat). Changes in these factors can help lower risks for heart disease, some types of cancer, diabetes, hypertension and musculoskeletal injuries. Results from PHLAME will provide information on how best to help adults achieve and maintain healthy lifestyles. |
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| Detailed Description | This is a randomized, controlled trial to implement and prospectively assess and compare the usefulness of two means to promote healthy behaviors. Subjects are fire fighters who are assigned to one of two interventions or the control condition using a balanced randomization by fire station. The two health promotion interventions are 1) a team-based intervention and 2) a one-on-one intervention with a health counselor. The team intervention is based on social-learning theory, with all members of the social unit simultaneously participating. The one-on-one intervention uses a transtheoretical model and motivational interviewing techniques at the individual level. The targeted outcomes are increased physical activity and fitness, improved nutrition (more than 5 servings of fruits and vegetables and less than 30 percent of calories as fat), and improved energy balance (healthy body weight). Secondary outcomes include increased measures of endurance, strength, flexibility, and back fitness; reduced LDL levels; decreased abdominal obesity; and enhanced quality of life. Changes in these outcome measures can help lower risks for heart disease, some types of cancer, diabetes, hypertension and musculoskeletal injuries. We will assess program effects at the station and individual level. We will analyze the hierarchical data (fire fighters nested at fire stations) using linear modeling and use latent growth modeling to examine change over time. In addition, we will use covariance structure models to identify constructs and latent paths among constructs that affect outcomes. Our large data set, nested study design, and prospective longitudinal assessment make these newer modeling techniques well suited for our data analysis. Results from PHLAME will provide information on health behavior change and health promotion for adults. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| 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 | Completed | ||||
| Enrollment ICMJE | 600 | ||||
| Completion Date | March 2003 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | |||||
| 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 ID ICMJE | NCT00006181 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | R01 AR45901, NIAMS-058 | ||||
| Study Sponsor ICMJE | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||
| Verification Date | March 2003 | ||||
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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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