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ObesityATHISNCT02407093

Army Training at High Intensity Study

A study testing High-Intensity Functional Training and Army Physical Readiness Training in people with Obesity, run by Kansas State University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Although soldiers must be ready to respond to occupational and war theatre demands at a moment's notice, there is an epidemic of overweight and obesity and a need for improved fitness and health in the military. Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
High-Intensity Functional Training and Army Physical Readiness Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
2 sitesUnited States
Study dates
28 Oct 2015to 28 Jun 2020
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 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • physical activity clearance to participate in the study via the Physical Activity Readiness Questionnaire;
  • willingness to adhere to study protocol and complete all study assessments; and
  • high likelihood of assignment to the military post over the 8 (+/-) 1-month course of the study.

Who cannot join

  • being on permanent or temporary medical profile or having any medical condition or injury which would prevent participation in the exercise protocols;
  • having a pacemaker or other implanted/internal electrical device;
  • currently on administrative leave or assigned to exclusively administrative duties; and
  • (if female) pregnant or lactating, or planning to become pregnant in the next 9-months.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Fort Leavenworth

    Leavenworth, Kansas, 66027

  • Kansas State University

    Manhattan, Kansas, 66506

Other trials in United States

About this study

Official title: HIFT for Obesity Prevention, Fitness and Health Promotion in Military Personnel

Although soldiers must be ready to respond to occupational and war theatre demands at a moment's notice, there is an epidemic of overweight and obesity and a need for improved fitness and health in the military. Using a cluster randomized clinical trial we propose to test the effectiveness of a High-Intensity Functional Training (HIFT) exercise intervention to improve the body composition and fitness of active duty military personnel. The effectiveness of the HIFT intervention will be compared to usual Army Physical Readiness Training. Main outcomes will include changes in body composition and traditional fitness measures, a test of combat-preparation, and measures of cardiovascular health risk for both groups.

Read the detailed description

We will examine the effectiveness of a high-intensity functional training (HIFT) exercise intervention compared to Army Physical Readiness Training (APRT) and their related dietary instructions in improving body composition (percent body fat [%BF], fat mass, lean body mass, weight) and domains of Total Force Fitness (TFF; Army Physical Fitness Test [APFT], aerobic capacity, power, strength, and combat preparation and readiness) in a 6-month cluster-randomized clinical trial (CRCT) with 2 (+/- 1) month follow-up. We also will examine the effects of both exercise programs on cardiovascular disease (CVD) health risk (resting heart rate, blood pressure). We will conduct assessments at baseline, 6-months, and 2-month follow-up (+/- 1 month). We also will assess training time/volume, injuries, adverse events, adherence, and participant satisfaction and account for demographic and psychosocial variables.

In our CRCT, we aim to recruit and randomize approximately 150 soldiers (n=15 clusters-staff groups/platoons-per condition with at least 5 soldiers nested within each cluster) comparing the effectiveness of HIFT versus usual care (APRT) on:

Specific Aim 1 - changes in body composition including: percent body fat (%BF), fat mass, fat free mass, and body weight.

We hypothesize that soldiers in the HIFT condition will be significantly more likely to decrease a. %BF and b. fat mass, and to increase c. fat free mass than those in the APRT condition; we expect both groups to d. maintain body weight.

Specific Aim 2 - changes in fitness (e.g., APFT, power, strength), while accounting for actual physical training time in each condition.

We hypothesize that soldiers in the HIFT condition will have significantly greater improvement in their performance on fitness tests when compared to those in APRT, despite significantly less total training time. These outcomes will help determine if functional-oriented training can result in better fitness and combat preparedness for Army personnel.

Conditions
Obesity
Being tested
High-Intensity Functional Training, Army Physical Readiness Training
Keywords
Body Composition, Military, High-Intensity Functional Training, Army Physical Fitness, CrossFit
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-Intensity Functional TrainingBehavioural

    Also called CrossFit

    Constantly varied functional movements performed at a high intensity and incorporating monostructural (aerobic), gymnastics (body weight) and/or weightlifting movements. CrossFit is a good model of HIFT for the military because of its emphasis on general physical preparedness and functional movements and because it is open source and programming is available at no cost (see www.crossfit.com). Sixty-minute HIFT sessions will include a warm-up, workout and cool down. Workouts will average 15 minutes in duration (range = 5-45 minutes) for a total of 50-100 minutes per week.

  • Army Physical Readiness TrainingBehavioural

    Also called Army PT

    Usual physical training program for Army personnel from directive FM 7-22, using the Reset phase. Exercises will address strength, endurance, and mobility training. APRT is designed to be completed in 60-90 minute sessions, 5 days/week for a total dose of 300-450 minutes per week.

Study groups in NCT02407093
Study groupRoleWhat they receive
High-Intensity Functional TrainingExperimentalCrossFit will be the HIFT intervention framework with training elements, exercise programming, and scheduling set by CrossFit staff. Workouts will be comprised of one or more of three exercise modalities: aerobic/monostructural (e.g., running), gymnastics (e.g., pullups), and weightlifting/resistance training with workouts designed to maximize use of equipment available in deployed environments (e.g.,vehicle tires). All workouts will be individually scaled to each soldier's current level of fitness by a certified trainer. Sessions will be standardized across the 6 months of intervention so that each cluster will receive exactly the same training.
Receives: Behavioral: High-Intensity Functional Training
Army Physical Readiness TrainingActive comparatorThe APRT program has combat readiness as the primary focus and is mandated for active duty personnel. For this study, APRT sessions have been standardized across the 6 months of the intervention according to FM 7-22 "Army Physical Readiness Training" manual so each cluster will receive the same training program using the Reset Phase. Sessions will consist of preparation, activities and recovery and will include strength, endurance, and mobility exercises that involve on-ground (e.g., running), off-ground (e.g., climbing), and combatives (e.g., striking and grappling) training, with supervision by a certified trainer.
Receives: Behavioral: Army Physical Readiness Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. body fat percentage

    The Tanita 300 digital bioelectrical impedance/weight scale will be used to estimate body fat percentage.

    Measured: 6 months

Secondary outcomes (12)

  1. aerobic capacity

    Aerobic capacity will be estimated from the time during the APFT 2-mile run.

    Measured: 6 months

  2. muscular power

    A standing horizontal jump will be used to assess power with the best of three attempts recorded.

    Measured: 6 months

  3. muscular strength

    We will assess participants' strength by determining their one repetition maximum (1RM) using the deadlift. Use of the 1RM test is a safe and reliable method of assessing strength in both trained and untrained subjects. The test procedure begins with a warm-up of 5-10 repetitions at 40% to 60% of the participant's estimated maximum. After a brief rest period, the load is increased to 60% to 80% of the participant's estimated maximum, attempting to complete 3-5 repetitions. At this point a small increase in weight is added to the load and a 1RM lift is attempted. The goal is to determine the participant's 1RM in 3 to 5 trials, allowing for ample rest (3-5 minutes) between each 1RM attempt.

    Measured: 6 months

  4. muscular endurance

    We will also assess upper body muscular endurance using the Marines pull-up test, where participants will complete as many consecutive strict pull-ups as possible before dropping off the bar.

    Measured: 6 months

  5. simulated victim rescue

    This test will simulate rescuing a wounded soldier on the battlefield. After a verbal signal, the participant will drag a 165-lb dummy 35-ft around a barrel and back 35-ft across the starting line for time.

    Measured: 6 months

  6. blood pressure

    An Omron BP785 10 series monitor will be used to assess blood pressure after the participant has been seated comfortably for at least 5 minutes.

    Measured: 6 months

  7. resting heart rate

    An Omron BP785 10 series monitor will be used to assess resting heart rate after the participant has been seated comfortably for at least 5 minutes.

    Measured: 6 months

  8. fat mass

    The Tanita 300 digital bioelectrical impedance/weight scale will be used to estimate fat mass

    Measured: 6 months

  9. fat free mass

    The Tanita 300 digital bioelectrical impedance/weight scale will be used to estimate fat free mass

    Measured: 6 months

  10. body mass index (BMI)

    Measured height (via stadiometer) and measured weight (via Tanita 300) will be used to calculate BMI

    Measured: 6 months

  11. waist circumference

    Waist circumference will be taken three times twice to the nearest 0.1 cm using standardized landmarks with a spring-loaded tape measure and will be used as a measure of central adiposity

    Measured: 6 months

  12. Army Physical Fitness Test (APFT)

    The APFT measures muscular and cardiorespiratory endurance and consists of 2 minutes of pushups, 2 minutes of sit-ups, and a 2 mile run with 10-20 minutes recovery between events.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2015 (estimated)
  2. Study start28 Oct 2015
  3. Primary completion28 Jun 2019
  4. Study completion28 Jun 2020

Resources

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
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02407093
Sponsor's protocol ID
1R01DK099516-01A1
Acronym
ATHIS
Status last verified
Nov 2020
First submitted
30 Mar 2015
Last updated
13 Nov 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Poston WS, Haddock CK, Heinrich KM, Jahnke SA, Jitnarin N, Batchelor DB. Is High-Intensity Functional Training (HIFT)/CrossFit Safe for Military Fitness Training? Mil Med. 2016 Jul;181(7):627-37. doi: 10.7205/MILMED-D-15-00273.

    PubMed 27391615

  • Haddock CK, Poston WS, Heinrich KM, Jahnke SA, Jitnarin N. The Benefits of High-Intensity Functional Training Fitness Programs for Military Personnel. Mil Med. 2016 Nov;181(11):e1508-e1514. doi: 10.7205/MILMED-D-15-00503.

    PubMed 27849484

  • Poston WS, Haddock CK, Heinrich KM, Jahnke SA, Jitnarin N, Batchelor DB, Feito Y, Suminski RR. Response: Is High-Intensity Functional Training (HIFT)/CrossFit Safe for Military Fitness Training? Mil Med. 2017 Jan;182(1):1476-1479. doi: 10.7205/MILMED-D-16-00369. No abstract available.

    PubMed 28051964

  • Feito Y, Heinrich KM, Butcher SJ, Poston WSC. High-Intensity Functional Training (HIFT): Definition and Research Implications for Improved Fitness. Sports (Basel). 2018 Aug 7;6(3):76. doi: 10.3390/sports6030076.

    PubMed 30087252

Questions about this trial

What is this clinical trial studying?

A study testing High-Intensity Functional Training and Army Physical Readiness Training in people with Obesity, run by Kansas State University at 2 sites 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 4 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 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

body fat percentage (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02407093, which also lists 4 linked publications.

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 13 Nov 2020.

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