ObesityNCT03181321
The First Twenty for Volunteer Firefighters
A study testing The First Twenty in people with Obesity and Cardiovascular Diseases, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to assess the efficacy of an internet-based firefighter health and wellness program for volunteer fire departments. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Cardiovascular Diseases, Occupational Injuries
- What is being tested?
- The First Twenty
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 419 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2014to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- not a first responder within a participating fire department
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of this study is to assess the efficacy of an internet-based firefighter health and wellness program for volunteer fire departments.
Read the 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.
- Conditions
- Obesity, Cardiovascular Diseases, Occupational Injuries
- Being tested
- The First Twenty
- Keywords
- nutrition, fitness, cardiovascular disease, firefighters, obesity, injury
- Medical subject headings
- Obesity, Cardiovascular Diseases, Occupational Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The First TwentyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Mass Index (BMI)
BMI from measured height and weight
Measured: baseline, 6 months
Change in Body Fat Percentage
body fat % from Tanita scale measurement
Measured: baseline, 6 months
Change in Waist Circumference
waist circumference from measured waist using a tape
Measured: baseline, 6 months
Secondary outcomes (2)
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).
Measured: baseline, 6 months
Change in self reported physical activity and inactivity
SRPA
Measured: baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start1 Nov 2014
- Primary completion1 Jun 2017
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 419 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Development and Research Institutes, Inc.
- Responsible party
- Principal investigator, Rena Sue Day, The University of Texas Health Science Center, Houston
- Investigators
- Rena S Day, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181321
- Sponsor's protocol ID
- HSC-SPH-14-0749
- Other IDs
- EMW-2013-FP-00983
- Status last verified
- Jun 2018
- First submitted
- 6 Jun 2017
- Last updated
- 29 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First Twenty for Volunteer Firefighters
- ClinicalTrials.gov ID
- NCT03181321
- Acronym / sponsor ID
- HSC-SPH-14-0749
- Conditions
- Obesity, Cardiovascular Diseases, Occupational Injuries
- Keywords
- nutrition, fitness, cardiovascular disease, firefighters, obesity, injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 419 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Development and Research Institutes, Inc.
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 8 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| The First Twenty | Experimental | Behavioral: The First TwentyThe 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. |
| Control | No intervention | –Participants in this arm will not be asked to change anything in their lifestyle during the 6 month period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- not a first responder within a participating fire department
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The First TwentyThe 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. | Behavioural | The First Twenty |
Primary outcome
Change in Body Mass Index (BMI)
Time frame: baseline, 6 months
BMI from measured height and weight
Change in Body Fat Percentage
Time frame: baseline, 6 months
body fat % from Tanita scale measurement
Change in Waist Circumference
Time frame: baseline, 6 months
waist circumference from measured waist using a tape
2 secondary outcomes
Change in Food and nutrient intake as assessed by the Food Frequency Questionnaire (FFQ)
Time frame: baseline, 6 months
Change in self reported physical activity and inactivity
Time frame: baseline, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rena S Day, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The First Twenty in people with Obesity and Cardiovascular Diseases, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index (BMI) (time frame: baseline, 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2018.