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Cardiovascular DiseasesPhase 2PHLAMENCT00006181

Promoting Healthy Lifestyles Among Firefighters

A Phase 2 study testing Team-based intervention and One-on-one intervention in people with Cardiovascular Diseases and Cancer, run by Oregon Health and Science University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Cardiovascular Diseases, Cancer, Physical Activity
What is being tested?
Team-based intervention and One-on-one intervention
How many people
600 participants
Where
1 siteUnited States
Study dates
Apr 1999to Mar 2003
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • All fit-for-duty fire fighters from Portland, OR, Salem, OR, Camas, WA, Battleground, WA and Brush Prairie, WA.

Who cannot join

  • Fire fighters who are planning on leaving employment within 1 year.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Oregon Health & Science University

    Portland, Oregon, 97201

Other trials in United States

About this study

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.

Read the 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.

Being tested
Team-based intervention, One-on-one intervention
Keywords
Health behavior change, Motivational interviewing, Motivational enhancement, Health counseling, Team intervention, One-on-one intervention, Physical activity, Exercise, Nutrition, Health assessments, Strength, Flexibility, Percent body fat, Social-learning theory, PHLAME, Fire fighters, Fire stations, Cancer, Cardiovascular diseases
Medical subject headings
Cardiovascular Diseases, Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Team-based interventionBehavioural

  • One-on-one interventionBehavioural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2000 (estimated)
  2. Study startApr 1999
  3. Primary completionMar 2003
  4. Study completionMar 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006181
Sponsor's protocol ID
R01AR045901
Other IDs
R01AR045901, NIAMS-058
Acronym
PHLAME
Status last verified
Mar 2003
First submitted
19 Aug 2000
Last updated
7 Jan 2014
Results posted
No

Publications

  • American College of Sports Medicine. Guidelines for Exercise Testing and Prescription. 5th ed. Williams & Wilkins, 1995.

  • American College of Sports Medicine position stand. The recommended quantity and quality of exercise for developing and maintaining cardiorespiratory and muscular fitness in healthy adults. Med Sci Sports Exerc. 1990 Apr;22(2):265-74.

    PubMed 2355825

  • Hankin JH, Wilkens LR. Development and validation of dietary assessment methods for culturally diverse populations. Am J Clin Nutr. 1994 Jan;59(1 Suppl):198S-200S. doi: 10.1093/ajcn/59.1.198S.

    PubMed 8279423

  • Kristal AR, Shattuck AL, Henry HJ. Patterns of dietary behavior associated with selecting diets low in fat: reliability and validity of a behavioral approach to dietary assessment. J Am Diet Assoc. 1990 Feb;90(2):214-20.

    PubMed 2303658

  • Mayer T, Gatchel R, Betancur J, Bovasso E. Trunk muscle endurance measurement. Isometric contrasted to isokinetic testing in normal subjects. Spine (Phila Pa 1976). 1995 Apr 15;20(8):920-6; discussion 926-7.

    PubMed 7644957

  • National Research Council (US) Committee on Diet and Health. Diet and Health: Implications for Reducing Chronic Disease Risk. Washington (DC): National Academies Press (US); 1989. Available from http://www.ncbi.nlm.nih.gov/books/NBK218743/

    PubMed 25032333

  • Ni Mhurchu C, Margetts BM, Speller VM. Applying the stages-of-change model to dietary change. Nutr Rev. 1997 Jan;55(1 Pt 1):10-6. doi: 10.1111/j.1753-4887.1997.tb06115.x.

    PubMed 9155212

  • Paffenbarger RS Jr, Hyde RT, Wing AL, Lee IM, Jung DL, Kampert JB. The association of changes in physical-activity level and other lifestyle characteristics with mortality among men. N Engl J Med. 1993 Feb 25;328(8):538-45. doi: 10.1056/NEJM199302253280804.

    PubMed 8426621

  • Shannon J, Kristal AR, Curry SJ, Beresford SA. Application of a behavioral approach to measuring dietary change: the fat- and fiber-related diet behavior questionnaire. Cancer Epidemiol Biomarkers Prev. 1997 May;6(5):355-61.

    PubMed 9149896

  • The Fire Service Joint Labor Management Wellness/Fitness Initiative. International Association of Fire Fighters, 1997.

  • Thompson FE, Byers T. Dietary assessment resource manual. J Nutr. 1994 Nov;124(11 Suppl):2245S-2317S. doi: 10.1093/jn/124.suppl_11.2245s. No abstract available.

    PubMed 7965210

  • Wing RR, Jeffery RW, Burton LR, Thorson C, Kuller LH, Folsom AR. Change in waist-hip ratio with weight loss and its association with change in cardiovascular risk factors. Am J Clin Nutr. 1992 Jun;55(6):1086-92. doi: 10.1093/ajcn/55.6.1086.

    PubMed 1595579

  • Moe EL, Elliot DL, Goldberg L, Kuehl KS, Duncan TE, Johnson RKR, DeFrancesco CA, Dulacki KN, Onsanit A. The PHLAME (Promoting Healthy Lifestyles: Alternative Models' Effects) Program: Pilot Year Findings. Poster presentation at Sixth International Congress of Behavioral Medicine, 15-18 November 2000, Brisbane, Australia.

  • Kuehl K, Elliot D, Goldberg L, Moe E, Johnson R, McGinnis W, Duncan T. PHLAME. Promoting Healthy Lifestyles: Alternative Models' Effects. Poster presentation at the National Cancer Institute's Health Promotion Branch Second Annual Meeting of Nutrition and Health Behavior Change Grantees, 9-10 September 2000, Washington, DC.

  • Elliot D, Goldberg L, Kuehl K, Moe E, Johnson R, Butterworth S. PHLAME. Promoting Healthy Lifestyles: Alternative Models' Effects. Poster presentation at the Redmond Foundation's Fifteenth Symposium on the Occupational Health and Hazards of the Fire Service, 22-26 August 1999.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Team-based intervention and One-on-one intervention in people with Cardiovascular Diseases and Cancer, run by Oregon Health and Science University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00006181, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2014; AzTrials last refreshed its copy on 6 Nov 2026.

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