- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03181321
The First Twenty for Volunteer Firefighters
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A national sample of volunteer fire departments will be recruited for a 6 month, CRCT with a cross-over treatment design to determine the efficacy of The First Twenty (TF20), a wellness program focused on nutrition and fitness for firefighters. Modifications to the existing TF20 will be made to enhance the health coaching features and include tools for program evaluation. Study outcomes (changes in weight, BMI, body fat percentage, waist circumference, dietary intakes, blood pressure, and fitness activities) will be assessed pre- and post-intervention.
This will be the first internet-based, occupationally tailored health and wellness program implemented for the volunteer fire service. TF20 will be an essential cost effective tool to address the epidemic of unhealthy body composition, nutrition and fitness among firefighters.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- first responder within a participating fire department
- willing to complete all assessments
- internet accessibility through a computer, tablet or smartphone and ability to use devices appropriately
Exclusion Criteria:
- not a first responder within a participating fire department
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: The First Twenty
The TF20 incorporates individual goal setting and health coaching, leveraging cultural aspects of the fire service and group cohesion to motivate behavior change.
The TF20 focuses on the unique needs of FF with culturally relevant nutrition and fitness strategies.
TF20 was primarily designed as a cost-effective, stand-alone program for departments which have no health promotion initiative.
Program components include practical approaches to nutrition, fitness and mental health.
|
The TF20 incorporates individual goal setting and health coaching, leveraging cultural aspects of the fire service and group cohesion to motivate behavior change.
The TF20 focuses on the unique needs of FF with culturally relevant nutrition and fitness strategies.
TF20 was primarily designed as a cost-effective, stand-alone program for departments which have no health promotion initiative.
Program components include practical approaches to nutrition, fitness and mental health.
|
No Intervention: Control
Participants in this arm will not be asked to change anything in their lifestyle during the 6 month period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Body Mass Index (BMI)
Time Frame: baseline, 6 months
|
BMI from measured height and weight
|
baseline, 6 months
|
Change in Body Fat Percentage
Time Frame: baseline, 6 months
|
body fat % from Tanita scale measurement
|
baseline, 6 months
|
Change in Waist Circumference
Time Frame: baseline, 6 months
|
waist circumference from measured waist using a tape
|
baseline, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Food and nutrient intake as assessed by the Food Frequency Questionnaire (FFQ)
Time Frame: baseline, 6 months
|
The Food and Frequency Questionnaire (FFQ) is a self-administered, semi-quantitative, food frequency questionnaire developed by the principal investigator.
The FFQ presents a food list, which contains items contributing most to selected nutrient intakes among firefighters and foods encouraged by the intervention.
FFQ data will be used to calculate usual nutrient intakes using the Food Intake Analysis System (FIASMe).
|
baseline, 6 months
|
Change in self reported physical activity and inactivity
Time Frame: baseline, 6 months
|
SRPA
|
baseline, 6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Rena S Day, PhD, The University of Texas Health Science Center, Houston
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-SPH-14-0749
- EMW-2013-FP-00983 (Other Identifier: FEMA)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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