NCT03181321

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
419

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

June 29, 2018

Status Verified

June 1, 2018

Enrollment Period

2.6 years

First QC Date

June 6, 2017

Last Update Submit

June 28, 2018

Conditions

Keywords

nutritionfitnesscardiovascular diseasefirefightersobesityinjury

Outcome Measures

Primary Outcomes (3)

  • Change in Body Mass Index (BMI)

    BMI from measured height and weight

    baseline, 6 months

  • Change in Body Fat Percentage

    body fat % from Tanita scale measurement

    baseline, 6 months

  • Change in Waist Circumference

    waist circumference from measured waist using a tape

    baseline, 6 months

Secondary Outcomes (2)

  • Change in Food and nutrient intake as assessed by the Food Frequency Questionnaire (FFQ)

    baseline, 6 months

  • Change in self reported physical activity and inactivity

    baseline, 6 months

Study Arms (2)

The First Twenty

EXPERIMENTAL

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.

Behavioral: The First Twenty

Control

NO INTERVENTION

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

Interventions

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 First Twenty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- not a first responder within a participating fire department

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

ObesityCardiovascular DiseasesOccupational InjuriesWounds and Injuries

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rena S Day, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 6, 2017

First Posted

June 8, 2017

Study Start

November 1, 2014

Primary Completion

June 1, 2017

Study Completion

April 30, 2018

Last Updated

June 29, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations