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Completed

NCT Number: NCT02760628

The First Twenty (TF20) for Volunteer Firefighters in a Clinic Based Setting

The First Twenty® (TF20) was recently developed as a not-for-profit, web-mobile program for firefighters (FFs) specifically focused on improving fitness and nutrition knowledge and practices. The program was designed by FFs with backgrounds in tactical fitness, marketing and program development professionals, and nutrition and exercise scientists. Preliminary data suggests the program is well-received by FFs and results in significant improvement in body composition and physical fitness. One innovative approach for the eventual dissemination of TF20 to VFFs is through their fitness-for duty medical exams. The synergy created by linking the TF20 intervention components, feedback to the VFFs from their medical exam, and health messages from their physician is predicted to maximize the impact of this much-needed intervention. The goal of the proposed project is to tailor TF20 for use in a clinic based setting (CB-TF20) for VFFs and to pilot test it in comparison to the American Heart Association's Life's Simple 7 (LS7), a web-based diet and physical activity knowledge/behavior and lifestyle program. The specific aims are to: 1) Conduct formative research with key stakeholders in the VFF community (e.g., physicians, department leadership, VFFs) to determine best practices for implementing a clinic-based, web-mobile health and wellness program with VFFs and medical providers; 2) Develop a clinic-based version of TF20 (CB-TF20) and beta-test it with VFFs; and, 3) Conduct a 6 month, 2-arm, pilot cluster (i.e., department) randomized clinical trial (PCRCT) to determine the comparative effectiveness of the revised CB-TF20 to LS7 on body composition, Framingham Risk Scores, and diet/physical activity knowledge and behaviors among VFF with BMI >25.0kg/m2; and conduct an evaluation of the CB-TF20 materials and technology. This innovative R34 study is a critical step in providing a much needed intervention for VFFs and those providing their annual examinations.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NDRI Institute of Bioebehavioral Health Research, Leawood, Kansas, United States

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About this study

The US fire service serves as the front line of defense against any domestic emergency and volunteer firefighters comprise the majority of firefighters, often with negative consequences for the health of personnel. While rates of overweight and obesity remain high among firefighters and cardiovascular disease remains the leading cause of line of duty deaths, few resources tailored to the unique culture and needs of firefighters are available to help occupational medicine physicians who provide their fitness for duty examinations. By engaging firefighters and occupational medicine clinicians in tailoring an internet/mobile intervention and pilot testing the program with a sample of volunteer firefighters, the investigators will be poised to implement a full-scale clinical trial with the developed program.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing to complete all assessments
  • Internet accessibility via computer, tablet or smartphone and ability to use devices appropriately
  • Medically cleared to participate in the program through clinicians
  • ≥18 years

Exclusion criteria

  • Not meeting inclusion criteria

Treatment and study plan

The First Twenty (TF20)

Behavioral

TF20 is an online wellness program for firefighters focused on improving cardiovascular risk factors through behavioral changes.

Life Simple 7 (LS7)

Behavioral

LS7 is a wellness program designed and implemented by the American Heart Association focused on improving cardiovascular health.

Primary outcomes

  1. Body Fat

    Time frame: 6 months

    Body fat as measured by foot-to-foot bio-electrical impedance

Secondary outcomes

  1. Framingham Risk Score

    Time frame: 6 months

  2. Body Mass Index (BMI)

    Time frame: 6 months

    BMI as calculated by weight in kilograms/height in meters squared

  3. Waist circumference

    Time frame: 6 months

    Waist circumference as measured in centimeters

Sponsors and collaborators

Lead sponsor

National Development and Research Institutes, Inc.

Other

Collaborators

  • The University of Texas Health Science Center, Houston

Registry information

Official study title

A Clinic and Tech-Based Diet and Fitness Intervention for Volunteer Firefighters

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 3, 2016
Registry last updated
Aug 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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