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The First Twenty for Volunteer Firefighters

Primary Purpose

Obesity, Cardiovascular Diseases, Occupational Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The First Twenty
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring nutrition, fitness, cardiovascular disease, firefighters, obesity, injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

The First Twenty

Control

Arm Description

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.

Participants in this arm will not be asked to change anything in their lifestyle during the 6 month period.

Outcomes

Primary Outcome Measures

Change in Body Mass Index (BMI)
BMI from measured height and weight
Change in Body Fat Percentage
body fat % from Tanita scale measurement
Change in Waist Circumference
waist circumference from measured waist using a tape

Secondary Outcome Measures

Change in Food and nutrient intake as assessed by the Food Frequency Questionnaire (FFQ)
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).
Change in self reported physical activity and inactivity
SRPA

Full Information

First Posted
June 6, 2017
Last Updated
June 28, 2018
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Development and Research Institutes, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03181321
Brief Title
The First Twenty for Volunteer Firefighters
Official Title
The First Twenty for Volunteer Firefighters
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2014 (Actual)
Primary Completion Date
June 1, 2017 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Development and Research Institutes, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to assess the efficacy of an internet-based firefighter health and wellness program for volunteer fire departments.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Cardiovascular Diseases, Occupational Injuries
Keywords
nutrition, fitness, cardiovascular disease, firefighters, obesity, injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The investigators will conduct a 6 month, two-arm, CRCT: TF20 vs. Control (which will receive delayed treatment after 6 months). Eligible fire departments volunteering for the trial will be randomized to one of the two study treatment arms. Treatment outcomes will be assessed at baseline and 6 months by our staff.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
419 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The First Twenty
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in this arm will not be asked to change anything in their lifestyle during the 6 month period.
Intervention Type
Behavioral
Intervention Name(s)
The First Twenty
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Body Mass Index (BMI)
Description
BMI from measured height and weight
Time Frame
baseline, 6 months
Title
Change in Body Fat Percentage
Description
body fat % from Tanita scale measurement
Time Frame
baseline, 6 months
Title
Change in Waist Circumference
Description
waist circumference from measured waist using a tape
Time Frame
baseline, 6 months
Secondary Outcome Measure Information:
Title
Change in Food and nutrient intake as assessed by the Food Frequency Questionnaire (FFQ)
Description
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).
Time Frame
baseline, 6 months
Title
Change in self reported physical activity and inactivity
Description
SRPA
Time Frame
baseline, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rena S Day, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The First Twenty for Volunteer Firefighters

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