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| Sponsors and Collaborators: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) National Cancer Institute (NCI) |
| Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| ClinicalTrials.gov Identifier: | NCT00006181 |
Purpose
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.
| Condition | Intervention | Phase |
|
Cardiovascular Diseases Cancer Physical Activity Nutrition |
Behavioral: Team-based intervention Behavioral: One-on-one intervention |
Phase II |
| Genetics Home Reference related topics: | Benign Tumors Cancer Heart Diseases Vascular Diseases |
| MedlinePlus related topics: | Cancer Fires |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | PHLAME: Promoting Healthy Lifestyles: Alternative Models' Effects |
| Estimated Enrollment: | 600 |
| Study Start Date: | April 1999 |
| Estimated Study Completion Date: | March 2003 |
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.
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Oregon | |||||
| Oregon Health & Science University | |||||
| Portland, Oregon, United States, 97201 | |||||
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
| National Cancer Institute (NCI) |
| Principal Investigator: | Diane L. Elliot, MD | Oregon Health and Science University |
More Information
Click here to visit the OHSU PHLAME Web site. 
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| Study ID Numbers: | R01 AR45901, NIAMS-058 |
| First Received: | August 19, 2000 |
| Last Updated: | January 2, 2007 |
| ClinicalTrials.gov Identifier: | NCT00006181 |
| Health Authority: | United States: Federal Government |
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