Cancer Clinical Trial
Official title:
PHLAME: Promoting Healthy Lifestyles: Alternative Models' Effects
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.
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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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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