- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02760628
The First Twenty (TF20) for Volunteer Firefighters in a Clinic Based Setting
August 20, 2018 updated by: National Development and Research Institutes, Inc.
A Clinic and Tech-Based Diet and Fitness Intervention for Volunteer Firefighters
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
198
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Kansas
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Leawood, Kansas, United States, 66224
- NDRI Institute of Bioebehavioral Health Research
-
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New York
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New York, New York, United States, 10010
- National Development and Research Institutes
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: The First Twenty (TF20)
Participants in TF20 will be provided an online wellness program focused on fitness and nutrition tailored to firefighters.
TF20 is interactive and involves health coaching.
|
TF20 is an online wellness program for firefighters focused on improving cardiovascular risk factors through behavioral changes.
|
Placebo Comparator: Life Simple Seven (LS7)
Participants assigned to the LS7 arm will be directed to a website that contains information about health and wellness from the American Heart Association that was developed for the general population.
No health coaching is present and the site is not tailored for the fire service.
|
LS7 is a wellness program designed and implemented by the American Heart Association focused on improving cardiovascular health.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Fat
Time Frame: 6 months
|
Body fat as measured by foot-to-foot bio-electrical impedance
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Framingham Risk Score
Time Frame: 6 months
|
6 months
|
|
Body Mass Index (BMI)
Time Frame: 6 months
|
BMI as calculated by weight in kilograms/height in meters squared
|
6 months
|
Waist circumference
Time Frame: 6 months
|
Waist circumference as measured in centimeters
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Sara Jahnke, PhD, National Development & Research Institutes
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2015
Primary Completion (Actual)
February 18, 2018
Study Completion (Actual)
February 18, 2018
Study Registration Dates
First Submitted
April 29, 2016
First Submitted That Met QC Criteria
April 30, 2016
First Posted (Estimate)
May 3, 2016
Study Record Updates
Last Update Posted (Actual)
August 22, 2018
Last Update Submitted That Met QC Criteria
August 20, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 1R34HL125790-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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