NCT02760628

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
198

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 3, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2018

Completed
Last Updated

August 22, 2018

Status Verified

August 1, 2018

Enrollment Period

2.2 years

First QC Date

April 29, 2016

Last Update Submit

August 20, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Body Fat

    Body fat as measured by foot-to-foot bio-electrical impedance

    6 months

Secondary Outcomes (3)

  • Framingham Risk Score

    6 months

  • Body Mass Index (BMI)

    6 months

  • Waist circumference

    6 months

Study Arms (2)

The First Twenty (TF20)

EXPERIMENTAL

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.

Behavioral: The First Twenty (TF20)

Life Simple Seven (LS7)

PLACEBO COMPARATOR

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.

Behavioral: Life Simple 7 (LS7)

Interventions

TF20 is an online wellness program for firefighters focused on improving cardiovascular risk factors through behavioral changes.

The First Twenty (TF20)

LS7 is a wellness program designed and implemented by the American Heart Association focused on improving cardiovascular health.

Life Simple Seven (LS7)

Eligibility Criteria

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NDRI Institute of Bioebehavioral Health Research

Leawood, Kansas, 66224, United States

Location

National Development and Research Institutes

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sara Jahnke, PhD

    National Development & Research Institutes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2016

First Posted

May 3, 2016

Study Start

December 15, 2015

Primary Completion

February 18, 2018

Study Completion

February 18, 2018

Last Updated

August 22, 2018

Record last verified: 2018-08

Locations