Clinical trial NCT02760628: The First Twenty (TF20) for Volunteer Firefighters in a Clinic Based Setting
Official title: A Clinic and Tech-Based Diet and Fitness Intervention for Volunteer Firefighters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: National Development and Research Institutes, Inc.
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center, Houston
First posted: 2016-05-03
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Body Fat
timeFrame: 6 months
Secondary outcomes:
measure: Framingham Risk Score
timeFrame: 6 months
measure: Body Mass Index (BMI)
timeFrame: 6 months
measure: Waist circumference
timeFrame: 6 months
Other outcomes:
Locations:
city: Leawood
country: United States
facility: NDRI Institute of Bioebehavioral Health Research
state: Kansas
city: New York
country: United States
facility: National Development and Research Institutes
state: New York
Study officials:
affiliation: National Development & Research Institutes
name: Sara Jahnke, PhD
role: PRINCIPAL_INVESTIGATOR
References: