Does Self-efficacy Predict Outcomes Among U.S. Military Academy Cadets During Initial Entry Training?
Phase: NA
Conditions: Low Back Pain, Musculoskeletal Injury
Sponsor: Keller Army Community Hospital

Does Self-efficacy Predict Outcomes Among U.S. Military Academy Cadets During Initial Entry 
Training? 
NCT05453110 
May 19, 2022 

*Please enter the full title of your study: 
Does self-efficacy predict injury and training outcomes among U.S. Military Academy cadets 
during initial entry training? 
*Please enter the Protocol Number you would like to use to reference the protocol: 
22KACH007 
* This field allows you to enter an abbreviated version of the Protocol Title to quickly identify 
this protocol. 
Is this a multi-site study (i.e. Each site has their own Principal Investigator)? 
No 
Does this protocol involve the use of animals? 
Yes •  No 
EIRB Protocol Template (Version 1.1) 
 
 
1.0 
General Information 
 
 
2.0 
Add Site(s) 
 
2.1 List sites associated with this study: 
-
mm-
mn Department Name 
@ 
P and R - Keller Army Community Hospital (KACH) 
 
3.0 
Assign project personnel access to the project 
 
 
3.1 *Please add a Principal Investigator for the study: 
 
 
Kreisel, Brian Robert, Doctorate of Science MAJ 
 
Select if applicable 
D Student 
D Resident 
 
D Site Chair 
Fellow 
 
 
3.2 If applicable, please select the Research Staff personnel: 
 
 
A) Additional Investigators 
 
 
Benedict, Timothy M, PhD, DPT LTC 
Associate Investigator 
Casper, Preston C, Doctorate in Physical Therapy LT 

4.1 
* What department(s) will be associated with this protocol? 
II 
Physi I Thernpyl 
4.2 
* Has another IRB/HRPP reviewed this study or will another IRB/HRPP be reviewing this study? If 
Yes, answer the questions according to the IRB/HRPP Determination. 
0 Yes  G No 
No records have been added 
4.3 * Is this a research study or a Compassionate Use/Emergency Use/HUD project? 
Associate Investigator 
Crowell, Michael SCOTT, DPT, DSc LTC 
Associate Investigator 
Dummar, Max Ken 
Associate Investigator 
Francis, Matthew W, DPT MAJ 
Associate Investigator 
Kuwik, Paul ANDREW, DPT 
Associate Investigator 
Scott, Kelly Maureen 
Associate Investigator 
B) Research Support Staff 
Miller, Erin Marie, PhD 
Research Coordinator 
3.3 *Please add a Protocol Contact: 
Benedict, Timothy M, PhD, DPT LTC 
Kreisel, Brian Robert, Doctorate of Science MAJ 
Scott, Kelly Maureen 
The Protocol Contact(s) will receive all important system notifications along with the Principal 
Investigator. (i.e. The protocol contact(s) are typically either the Protocol Coordinator or the 
Principal Investigator themselves). 
3.4 If applicable, please select the Designated Site Approval(s): 
Haley, Chad Allen 
Department Chair 
Add the name of the individual authorized to approve and sign off on this protocol from your Site 
(e.g. the Site Chair). 
 
4.0 
Project Information 
 
 

 
5.0  
Personnel Details 
 
 
5.1 List any Research Team members without EIRB access that are not previously entered in the 
protocol: 
INorecords have been added 
I 
5.2 
Will you have a Research Monitor for this study? 
0 Yes 
@ No 
0  N/A 
 
6.0  
Data/Specimens 
 
 
6.1  Does the study involve the use of existing data or specimens only (no interaction 
with human subjects}? 
@ Yes  O No 
4.4 
What type of research is this? 
I?Biomedical Research 
r Behavioral Research 
0 Educational Research 
C Psychosocial Research 
D Oral History 
D Other 
r Clinical trial (FDA regulated) 
4.5 Are you conducting this project in pursuit of a personal degree? 
@ Yes  O No 
4.7 * Is this human subjects research? (As defined by 32 CFR219} 
Human subject means a living 
individual about whom an investigator (whether professional or student} conducting research: 
(i} Obtains information or biospecimens through intervention or interaction with the individual, and 
uses, studies, or analyzes the information or biospecimens; or 
(ii} Obtains, uses, studies, analyzes or generates identifiable private information or identifiable 
biospecimens. 
® Yes  O No 
4.8 * Do you believe this human subjects research is exempt from IRB review? 
0 
Yes  @ No 

8.1 
Is this a collaborative or multi-site study? (e.g., are there any other institutions involved?) 
0 
Yes  @ No 
8.2 
Study Facilities and Locations: 
other: 
No records have been added 
8.3 
Are there international sites? 
Attach international approval documents, if applicable, when prompted. Note: Ensure local 
research context has been considered 
0  Yes  Gi No 
7.1 
Source of Funding: 
Total amount of funding: 
7.2  Do you or any other Investigator(s) have a disclosure of a personal interest or financial nature 
significant with sponsor(s), product(s), instrument(s) and/or company(ies) involved in this study? 
0  Yes 0 
No 
If Yes, complete and attach Conflict of Interest forms for all key personnel 
 
 
7.0  
Funding and Disclosures 
 
 
 
8.0  
Study Locations 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Keller I 
 
Army 
Army 
Community 
Performance 
site 
000029527 
10/28 
/2025 
Hospital 
 
 
 
0 
Yes @ No 

 
8.4 
Is  this an ocoNus (Outside Continental United States) study? 
0 
Yes  @ No 
Select the area of responsibility: 
Have you obtained permission from that area of responsibility? (This is a requirement prior to 
study approval) 
0 
Yes  O No 
 
9.0  
Study Details 
 
 
9.1 
Key Words: 
 
 
Provide up to 5 key words that identify the broad topic(s) of your study 
 
self-efficacy; musculoskeletal injury; tactical performance; initial-entry training 
 
 
9.2 
Background and Significance: 
 
 
Include a literature review that describes in detail the rationale for conducting the study. Include 
descriptions of any preliminary studies and findings that led to the development of the 
protocol. The background section should clearly support the choice of study variables and 
explain the basis for the research questions and/or study hypotheses. 
the relevance of the study and explains the applicability of its findings 
This section establishes 
 
Since World War I, U.S. Army leaders have faced a challenging conundrum: conduct training 
tough enough to prepare Soldier for warfare's physical and mental demands without causing so many 
injuries that units become non-deployable (East, 2013). The steady decline in physical activity levels 
and increases in overweight and obese adolescents (Center for Disease Control and Prevention 
/Division of Adolescent, 2020) has continued to widen the physical readiness gap between the general 
population and military physical demands (Alemany et al., 2021). This disparity increases the difficulty 
to train physically capable recruits without injuring those who are less fit. 
 
Despite efforts to improve Soldier readiness, as many as 58,400 Soldiers were not capable to 
deploy in April 2020, which is equivalent to 13 Brigade Combat Teams (Department of the Army, 
2020). More than half (31,500) were due to either temporary or long-term physical limitations, 
including musculoskeletal injuries (MSKls). MSKls are the leading cause of nondeployability, lost duty 
days (LDD), medical encounters, military discharge, and disability (Molloy, Pendergrass, Lee, 
Chervak, et al., 2020; Roy et al., 2021). In 2018 the U.S. Army spent $434 million in direct medical 
costs alone to treat MSKls (Molloy, Pendergrass, Lee, Chervak, et al., 2020). 
 
Ironically, the leading causes of MSKls are same activities that leaders deliberately conduct to 
develop physical resilience: running, foot marching, other physical fitness training activities (besides 
running) and work-related tasks (Roy et al., 2021). Although physical training results in the highest 
number of total injuries, obstacle courses and ruck marching have greater injuries per exposure 
(Lovalekar et al., 2021). Other common causes of MSKls include overexertion, falls/slips, and 
accidental injury (Army Public Health Center, 2021). 
 
Lower back injuries are a common occurrence in athletes and sports programs. They are 
especially common in sports in which athletes train strength and power movements, such as 
powerlifting and weight lifting (Bengtsson, 2018; Reichel, 2019; Stromback, 2018). Tactical athletes- 
referring to firefighters, police officers, and military servicemembers- report similar prevalence of low 
back pain (LBP), often due to heavy equipment worn or carried for their jobs (Roy, 2021). In the US 
military, musculoskeletal (MSK) injuries are highly prevalent and costly in lost duty days, depleted 
readiness to deploy, and medical expenses(Grimm, 2019; Teyhen, 2018). 
Researchers have identified multiple physical and behavioral MSKI risk factors including prior 
injury, female gender (Hearn et al., 2021; Kucera et al., 2016), high or low BMI (Lovalekar et al., 2021; 
Rappole et al., 2017), history of smoking, low aerobic endurance (Molloy, 2016; Rappole et al., 2017), 

and (to a lesser extent) muscular strength and endurance (Jones et al., 2017). Unit leaders and 
military trainers have used these study outcomes to develop injury prevention and training program 
including physical fitness programs, MSKI risk screening and leader education with mixed results 
(Canham-Chervak et al., 2015; Lovalekar et al., 2021; Molloy, Pendergrass, Lee, Hauret, el al., 2020; 
Terry et al., 2018). 
These epidemiological and correlational studies summarize the dilemma: Soldiers with prior injury 
and lower fitness levels tend to get injured (again) while training to improve their physical fitness. It is 
possible that other modifiable risk factors exist that, if trained, do not carry such high injury risk. 
The Army's new mandatory fitness test- Army Combat Fitness Test (ACFT)- is a comprehensive 
assessment of strength, power, speed, and endurance, and represents a dramatic shift from the 
previous fitness lest that primarily evaluated soldiers' endurance. One event of the ACFT is a three- 
repetition maximum deadlifl. The addition of a required deadlifl strength test has raised concern 
amongst servicemembersand healthcare workers about the risk of injury (Hauschild, 2019; Kind, 
2019). The Army doctrine specifies the purpose of testing this event is to evaluate a soldier's lower 
body and core strength to safely lift heavy equipment, and the graders are instructed to not permit any 
lumbar flexion during the deadlift. (Army Field Manual 7-22). 
Many coaches and physical therapists agree that lumbar flexion should not be permitted during a 
deadlifl (Nolan, 2019; Sjoberg, 2020; Spencer, 2015) however the majority of the research supporting 
this is based on empirical data derived from biomechanical or cadaver studies (Arjmand, 2005; 
Cholewicki, 1991; Dolan, 1994; Faber, 2009; Gallagher, 2012; Potvin, 1991; von Arx, 2021; Wade, 
2014). There is some debate amongst researchers regarding the importance of avoiding lumbar 
flexion for injury back injuries during a deadlift (Adams, 1986, 1994; Beach, 2018; Spencer, 2015). 
Alberto Bandura (1977) introduced self-efficacy as one's confidence to perform a specific task. In 
behavioral psychology, this concept helps patients and clinicians establish a therapeutic path by 
accomplishing individualized, increasingly difficult tasks (Bandura, 1977). Multiple subsequent 
publications have proposed positive relationships between self-efficacy and self-regulation (Bandura, 
1982), performance (Bandura, 1982; Feltz et al., 2008), goal-setting (Brinkman et al., 2020) and motor 
learning (Beattie et al., 2014). 
Performance effects resulting from the messages provided to athletes shouldn't be ignored, and 
this is referred to as placebo (has a perceived positive effect) or nocebo (has a perceived negative 
effect (Horvath, 2021). Theconcept of performance decline after negatively-perceived stimulus has a 
less robust presence in the literature than placebo effects, though this is evolving. Numerous recent 
studies have now documented the significant detriments to physical performance when subjects are 
exposed to negative or potentially threatening information (Cook, 2012; Corsi, 2019; Emadi Andani, 
2015; Horcajo, 2019; Jackson, 2005; Pollo, 2012; Zech, 2019). 
To our knowledge, there are no longitudinal studies evaluating the risk of injury from deadlifting 
with a flexed lumbar spine resulting in no clear evidence that a flexed spine is a risk factor for injury. 
However, it is well documented that information related to potential threat (nocebo) can adversely 
affect physical performance. Our research aim is to determine if cautionary information about the risk 
of spine injury harms performance on a maximum strength test compared to a message of spine 
resiliency. The cautionary education is similar to standard information provided to many 
servicemembers before the start of an ACFT or a maximum deadlifl. 
9.3 
Objectives/Specific Aims/Research Questions: 
Describe the purpose and objective(s) of the study, specific aims, and/or research questions 
/hypotheses 
1. Determine if general self-efficacy is a predictor of injury during Cadet Basic Training(CBT) by 
performing a Kaplan-Meier Survival Curve of a single self-efficacy assessment (Cadet General Self- 
Efficacy Assessment) and injury occurrence using the Defense Medical Surveillance System (DMSS), 
Cadet Illness and Injury Tracking System (CIITS), Armed Forces Health Longitudinal Technology 
Application (AHLTA) and a follow-up self-reported injury assessment. 
1. Independent Variable: Cadet General Self-Efficacy score 

2. Dependent Variables: Injury report according to CIITS, AHLTA, DMSS, sick call report or self- 
reported 
 
2. Determine if task-specific self-efficacy is a predictor of injury during specific CBT events by 
performing a Kaplan-Meier Survival Curve, a single assessment of cadet task-specific self-efficacy 
and injury occurrence using DMSS, CIITS, AHLTA and a follow-up self-reported injury assessment. 
1. Independent Variable: Cadet Task-Specific Self-Efficacy score 
2. Dependent Variables: Injury report according to DMSS or self-reported 
 
3. Determine if general self-efficacy is a predictor of performance during CBT by performing a 
multivariate regression between a single self-efficacy assessment and multiple measures of 
performance during CBT including 1) successful completion (pass/fail), 2) Army Combat Fitness Test 
(ACFT) raw or calculated score, 3) Warrior Competition performance, 4) marksmanship score, 5) 
written exams, 6) swimming assessment and 7) any other individually graded events. 
1. Independent Variable: Cadet General Self-Efficacy score 
2. Dependent Variables: performance outcome by event- 1) successful completion (pass/fail), 2) 
Army Combat Fitness Test (ACFT) score, 3) Warrior Competition performance, 4) marksmanship 
score, 5) written exams, 6) swimming assessment and 7) any other individually graded events. 
 
4. Determine if task-specific self-efficacy is a predictor of performance during CBT by performing a 
multivariate regression between a single (or multiple) assessments of cadet task-specific self-efficacy, 
and multiple measures of performance during CBT including 1) successful completion (pass/fail), 2) 
Army Combat Fitness Test (ACFT) raw or calculated score, 3) Warrior Competition performance, 4) 
marksmanship score, 5) written exams, 6) swimming assessment and 7) any other individually graded 
events. 
1. Independent Variable: task-specific self-efficacy scores 
2. Dependent Variables: performance outcome by event including 1) successful completion (pass 
/fail), 2) basic rifle marksmanship qualification score, 3) 12-mile road march outcome (pass/fail), 4) 
Army Combat Fitness Test (ACFT) score, 5) land navigation score, 6) swimming assessment outcome 
(pass/fail) and 7) any other individually-graded events. 
 
5. After completing CBT, determine which sources of self-efficacy ((1) enacting mastery experiences, 
2) vicarious experiences, 3) verbal persuasion, 4) physiological state, 5) affective state, 6) mental 
imagery) were the most influential on cadets' self-efficacy throughout CBT specific tasks by 
conducting a Chi-square test. 
1. Independent Variable: reported level of influence of each (6) source of self-efficacy. 
2. Dependent Variables: performance outcome by event including 1) successful completion (pass 
/fail), 2) basic rifle marksmanship qualification score, 3) 12-mile road march outcome (pass/fail), 4) 
Army Combat Fitness Test (ACFT) score, 5) land navigation score, 6) swimming assessment outcome 
(pass/fail) and 7) any other individually-graded events. 
 
6. Determine the effect of low back pain education (cautionary vs resiliency) on deadlift performance 
(weight lifted). 
We will analyze this with MDL weight lifted as the dependent variable (one-way ANOVA), with a 
planned comparison analysis if significant differences are found between groups. 
 
7. Determine the degree of confidence cadets have in their ability to succeed at the MDL both before 
and after the education and MDL 
We will analyze if there is a main effect of time in the pre-to-post self-efficacy scores with a paired t- 
test. We will use multiple regressions to analyze the impact of self-efficacy scores on MDL 
performance. 
 
8. Determine the effect of low back pain education (cautionary vs resiliency) on deadlift self-efficacy. 
We will analyze change scores with one-way ANOVA with planned comparisons between groups if 
ANOVA is significant. 
 
9. Determine the effect of low back pain education (cautionary vs resiliency) on perceived spine 
vulnerability on a deadlift. 
We will analyze change scores with one-way ANOVA with planned comparisons between groups if 
ANOVA is significant. 
 
 
9.4 
Study Design: 

 
I 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10.0 
Study Procedures, Data Management, and Privacy 
 
 
10.1 Study Procedures: 
 
Describe step-by-step how the study will be conducted from beginning to end 
Phase I: Consent and Self-Efficacy Assessment 
All new cadets are eligible to participate in this study and willreceive verbal and written study desc1iption 
dming the first or second week of cadet basic training. Immediately after consenting to pat1icipate, they will 
complete the study demographic data information ai1d the Cadet Basic Training Projective Performance 
Describe study design in one to two sentences (e.g., prospective, use of existing records/data 
/specimens, observational, cross-sectional, interventional, randomized, placebo-controlled, 
cohort, etc.). Specify the phase - Phase I, II, III, orIV- forFDA-regulated investigational drug 
research 
TI1is study willbe a randomized controlled trial withparallel design and I:I allocationratio. Weplanto use 
cluster randomization. We willhave three groups- control, cautionary, resiliency (Jackson, 2005). 
I 
9.5 
Target Population: 
Describe the population to whom the study findings will be generalized 
U.S. Military Academy Cadets 
9.6 Benefit to the DoD: 
State how this study will impact or be of benefit to the Department of Defense 
Researchers inside and outside of the military have also found that self-efficacy predicts both 
performance and is negatively correlated with MSKI (Gruber et al., 2009; Samuels et al., 2010). In a 
study on Navy SEAL training resilience, researchers found that successful graduation was related to 
physiological markers of resilience (Ledford et al., 2020). However, few studies have investigated the 
combined effects of physical, behavioral and psychological factors on predicting MSKls. 
Cadet basic training (CBT) at the United State Military Academy (USMA) is a 7-week initial-entry 
training event that physically and psychologically prepares cadets to become officers. It includes 
similar training events and physical demands as other initial-entry military courses such as a 12-mile 
foot march with 35 lbs., physical training including running multiple days per week, weapons 
familiarization, and basic tactical training. The injury risk factors for cadets attending CBT are similar 
to trainees attending U.S. Army Basic Combat Training and regular military training even though injury 
incidence is lower (Hearn et al., 2021). Identifying self-efficacy as an injury risk factor is the first step 
to designing and implementing injury prevention measures. The purpose of this study is to investigate 
relationships between performance, MSKI and self-efficacy alone and in combination with other MSKI 
risk factors in USMA cadets participating in CBT. 
There is currently an emphasis in Army Doctrine (FM 7-22) on form/technique for events on the 
ACFT, especially the maximum deadlift (MDL) and the prevention of lower back injuries. The rationale 
behind this is due to the perception that breakdowns in form during the deadlift lead to injuries, 
however, the research does not support this. Specifically, the research is unclear regarding the 
position of the spine while deadlifting- neutral vs flexed. Our results could impact future DoD 
publications regarding technique on the MDL and de-emphasize the role of a rounded spine as a 
safety concern. 
The researchers hypothesize that self-efficacy (general and task-specific) will be positively 
correlated with successful completion and performance and negatively correlated with MSKI risk 
during CBT. The researchers will also explore the relationship between self-efficacy and other known 
injury risk factors. Furthermore, we hypothesize that such beliefs about the vulnerability of the spine to 
injury might contribute to future disabling beliefs about back pain. This research marks an important 
step in investigating the role of beliefs about the back and readiness. 

Invent01y, which assesses self-efficacy measured prospectively via questionnaire on a IO-point Likert 
scale from 1 (no confidence) to 10 (folly confident) for overall perfonnance dming cadet basic training, 
marksmanship/live fire training, mck marching 12 miles, land navigation, swimming, and the Anny 
Combat Fitness Test. It will also assess for any recent injuries and whether the injmy is cuffently 
hinde1ing them. 
 
Phase 2: Injury Smveillance During Cadet Basic Training 
TI1e researchers will monitor the Cadet Injury and Illness Tracking System (CIITS), Aimed Forces 
Health Longitudinal Technology Application (AHLTA) and the Defense Medical Stnveillance System 
(DMSS) up to weekly to track injmies for the duration and for up to 9 weeks afte1wards. They will 
classify injuries as by diagnosis, region, and impact on training ("not injured" (1), "injured-not 
limited" (2), "injured-modified training" (3) and "injured-limited" (4)). Cadets will initially be defaulted 
as "not injured" (1). They will also complete the Single Assessment Nllllleric Evaluation (SANE), rating 
their cuffent ability level on a scale of 0- 100% with regards to their injury. 
 
Phase 3: Maximum Deadlift and Low Back Pain Education 
TI1e randomized control element of this study will occur before and during the maximum deadlift (MDL) 
of the Aimy Combat Fitness Test. At the start of cadet basic training, researchers will randomly allocate 
each company of cadets into a group receiving a cautionary message regarding risk of spine injmy, a 
group receiving a reassming me.ssage of spine resiliency, and a group receiving no education prior to 
the MDL. This education will include infonnation about the lumbar spine as it relates to a deadlift. The 
researchers will administer this education shortly prior to cadets taking the MDL. Cadets, test graders, 
and data analysts will all be blinded to group allocation. The researchers will collect MDL scores from 
each group and explore relationships between group assigmnent and MDL performance. 
 
Because the study is deceptive, all subjects will be provided a handout with best-evidence summary 
statements on how to maintain a healthy back as a cadet and beyond. All patiicipants will be given 
this infonnation, debriefed and provided an opportunity to speak with a licensed physical therapist 
about any concerns they might have about their back or lifting for the deadlift at a later date. 
 
Phase 4: Perfo1mance Outcomes 
TI1e researchers will receive cadet perfonnance outcomes from the Department of Militaiy 
Instmction (DMI) and the Department of Physical Education (DPE). At a minimum, this will include 
overall outcome (pass/fail) and Aimy Combat Fitness Test (ACFT) raw ai1d calculated scores. If 
available, this will also include marksmanship score, live fire score, land navigation score, swim 
test pass/fail outcome, road maid1pass/fail outcome. TI1e reseai·chers will enter this data into the 
reseai·ch database. 
 
Phase 5: Post-Cadet Basic Training Injmy Questionnaire and Self-Efficacy Sources 
After cadet basic training, the cadets will complete an electronical injmy assessment questionnaire. 
This v.ri.11 ensm·e that any cadets who coped with an injmy or self-modified training (such as 
pe1fonning at a lower level) ai·e also captured. This questionnaire will also classify the injuries 
according to the saine classification system as in phase 2. Thecadets will also answer questions 
related to the sources of confidence dming task-specific CBT events. 
 
 
10.2 Data Collection: 
 
 
Describe all the data variables, information to be collected, the source of the data, and how the 
data will be operationally measured. 
 
Cadet Demographics: Age, gender, height, weight, USMA Preparatory School attendance, 
intended athletics participation, intended USMA performance 
 
Injury Questionnaire: Recent injury information (within last year), still effecting performance, 
and Single Assessment Numeric Evaluation (SANE), and after-cadet basic training injury 
presence, region, and limiting classification 
 
Self-Efficacy: Overall Cadet Basic Training performance, marksmanship, buddy team live fire, 
swimming 150 yards, ruck marching (load carriage), ACFT, deadlift, land navigation 
 
Maximum Deadlift (MDL) performance: Measured by the amount of weight successfully lifted 
during the ACFT. 
 
Reported Self-Efficacy Source: Measured on the post-CBT survey using Qualtrics. The cadets will 
rank-order commonly cites sources of self-efficacy from most to least influential. The options will 
include commonly-cited self-efficacy sources: physiological state, previous experiences, affective 
state, mental imagery, vicarious experiences, and verbal persuasion. 
 
 
10.3 At any point in the study, will yourequest, use, or access health information in any form, including 

verbal, hard copy and electronic? 
 
 
® Yes  O No 
 
10.4 Review the definitions below and respond to the following two questions. If you are not sure of the 
answers, email DHA.PrivacyBoard@mail.mil for assistance. The Military Health System (MHS} is 
defined as all DoD health plans and DoD health care providers that are organized under the 
management authority of, or in the case of covered individual providers, assigned to or employed by, 
the Defense Health Agency (DHA), the Army, the Navy, or the Air Force  MHS workforce members 
are employees, volunteers, trainees, and other persons whose conduct, in the performance of work 
for the MHS, is under the direct control of the MHS, whether or not they are paid by the MHS.  MHS 
business associates are persons or entities that provide a service to the MHS and require protected 
health information (PHI) to provide the service. 
 
 
Are you an MHS workforce member? 
 
@ Yes, I am an MHS workforce member 
0  No, I am not an MHS workforce member 
 
Are you an MHS business associate? 
 
0 Yes, I am an MHS business associate 
@ No, I am not an MHS business associate 
 
 
10.5 Have you consulted with an MHSdata expert to determine the data elements required for your study? 
 
 
Consulting with a data expert often saves time later in the compliance process because the data 
expert can advise on the data available in the numerous MHS information systems, the quality of 
that data and the methods for encrypting and collapsing data. To schedule a consult with an 
MHS data expert, send an email to: (DHA.PrivacyBoard@mail.mil) 
0  Yes, then complete the questions below according to the data consult 
® No, then complete the questions below according to the best of your knowledge 
 
10.6 Indicate how you will request data from the MHS. Select all that apply. 
 
 
Talking with MHS health care providers or MHS health plans about specific research 
participants 
D Obtaining MHS hard copy records specific to research participants 
Obtaining data from an MHS information system(s) 
 
10.7 If youare obtaining data from an MHSinformation system(s), indicate whether you plan to receive a 
data extract or whether you plan to access an MHS information system directly to create a data set. 
 
 
A data extract is when the MHS or a contractor provides the data set directly to the 
researcher. When receiving a data set through data extract, the researcher may indicate 
whether the data elements should be provided as is, encrypted or collapsed. In contrast to a 
data extract, access to an information system means that the researcher may directly access an 
MHS information system and create a data set for the research study 
 
Data Extract 
P' Access 
 
10.8 Do youintend to request de-identified data from the MHS in your research study? 
 
 
There are different two methods for de-identifying data pursuant to HIPAA: 
1) Safe Harbor Method: Removing all of the identifiers listed in Table 1 below, provided that the 
researcher does not have actual knowledge that the remaining data can be used alone or in 
combination with other information to identify the individual who is the subject of the information 

M 
2) 
I 
ace 
Statistical Method: An expert, with appropriate knowledge of and experience with generally 
epted statistical and scientific principles and methods for rendering information not 
individually identifiable, determines that the data is not individually identifiable 
0 
Yes  ® No 
 
10.9 Indicate the MHSinformation system(s) from which you will seek to obtain data 
 
 
Ify oudo not know which system(s) contains the data elements you need, refer to the Guide for 
DoD Researchers on Using MHS Data or request guidance from an MHS data expert at: DHA. 
PrivacyBoard@mail.mil. 
 
Beol w is a list of commonly used MHS systems. If the system from which you seek to obtain 
daat is not listed below, list the name of the system in the "Other MHS Systems" category below 
PHI Systems: 
 
  HS Information System 
Requesting Data 
 
 
 
I 
AHLTAI 
 
I 
DMssl 
 
I 
TMoosl 
I= 
IYesl 
 
 
I= 
IYesl 
 
 
I=   IYesl 
 
PII 
-Only Systems: 
 
M  HS Information System 
 
No records have been added 
 
De -Identified Data & Other Systems: 
 
In formation System 
Requesting Data 
 
Other MHS System (May include PII and/or 
PHI) 
 
List other system here: 
 
Cadet Illness and Injury Tracking System 
(CITTS) 
IYesl 
 
 
 
 
10.10 Do you intend to merge or otherwise associate the requested data with data from any sources 
outside of the MHS, including other DoD systems that are not part of the MHS? 
 
0 Yes, will merge data 
®No, will not merge data 
 
10.11 Indicate the data elements about research participants or relatives, employers, or household 
members of the research participants that youwill request from MHShard copies or from MHS 
information systems. 
If you will merge data, also indicate non-MHS data elements about research participants or 
relatives, employers, or household members of the research participants that youwill have access 
to in any form or medium. 
,- 
 
.,,, 
1. 
I 
 
Names 
□ 
 
□ 
Ci 

 
2. Postal address 
with only town, 
city, state and zip 
code 
□ 
□ 
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3. Postal address 
with all geographic 
subdivisions smaller 
than a state, 
including street 
address, city, 
county, precinct, 
zip code and their 
equivalent 
geocodes, except 
for the initial three 
digits of a zip code 
if, according to the 
current publicly 
available data from 
the Bureau of 
Census: 1) the 
geographic unit 
formed by 
combining all zip 
codes with the 
same three initial 
digits contains 
more than 20,000 
people; and 2) the 
initial three digits of 
a zip code for all 
such geographic 
units containing 
20,000 or fewer 
people is changed 
to 000 
□ 
□ 
0 
4. Dates including 
all elements 
(except year) 
directly related to 
an individual, 
including birth date, 
admission date, 
discharge date, and 
date of death 
n 
[J 
-- 
5. Ages over 89 
and all elements of 
dates (including 
year) indicative of 
such age, unless 
you will only 
request a single 
category of "age 90 
or older" 
0 
0 
Ci 
6. Telephone 
numbers 
□ 
I'] 
r 
7. Fax numbers 

 
n 
n 
r 
8. Electronic mail 
addresses 
n 
rJ 
r 
9. Social Security 
numbers (SSNs) 
□ 
n 
r 
10. Medical record 
numbers 
□ 
0 
r 
11. Health plan 
beneficiary numbers 
n 
rJ 
n 
12. Account 
numbers 
D 
D 
C 
13. Certificate 
/license numbers 
D 
D 
C 
14. Vehicle 
identifiers and 
serial numbers, 
including license 
plate numbers 
r1 
r:"J 
r 
15. Device 
identifiers and 
serial numbers 
□ 
D 
C 
16. Web Universal 
Resource Locators 
(URLs) 
□ 
□ 
D 
17. Internet 
Protocol (IP) 
address numbers 
D 
D 
C 
10 
o; ............,,. 1-.,.;,.. 
.LU. UIUII lt::LI 1\... 
identifiers, 
including finger and 
voice prints 
□ 
D 
C 
19. Full-face 
photographic 
images and any 
comparable images 
n 
D 
r 
20. Any other 
unique identifying 
number, 
characteristic, or 
code (Diagnosis, 
n 
0 
r 

 
 
 
DEERS ID, EDIPI, 
Rank) 
 
 
 
If you are obtaining SSNs, provide a justification as to why and explain why a substitute cannot 
be used 
 
 
10.12 Do youbelieve it is possible for the MHS data to become identifiable because of triangulation, a 
small cell size, or any unique data element(s)? 
 
 
Triangulation means using different data elements that are not themselves identifiable but that 
when combined can be used to identify an individual. For example, triangulation would use rank 
and race together to determine the identity of an individual with a particular health condition. 
 
Small cell size means that there is only a small number of eligible individuals that satisfy the 
category description. Guidance for acceptable cell size is available from the Centers for Medicare 
and Medicaid Services. For example, the rank category of four star generals with a particular 
diagnosis may be less than 30, so the rank category may need to be expanded to include lower 
ranks. 
 
A unique data element includes any unique features that are not explicitly enumerated in the 
categories of data in rows 1 - 20 of the table above (in Section 10.10), but that could be used to 
identify an individual. Unique data elements include characteristics that are not themselves 
identifying, such as the rank of general or admiral, or a race or gender, but within the context of 
other information could be identifiable. 
0  Yes, I believe there is a reasonable possibility the MHS data will become identifiable 
@ No, I believe there is no reasonable possibility the MHS data will become identifiable 
 
 
10.13 Have you completed and uploaded an appropriate HIPAA document ( i.e. HIPAA Authorization will 
be obtained or Waiver/alteration of HIPAA Authorization is being requested)? 
 
 
@ Yes 
0 
No 
0 N/A 
 
10.14 Managing Data (Data Management and/or Sharing Plan) and/or Human Biological Specimens for 
this Study: 
 
 
Include in this section the plan for acquiring data (both electronic and hard copy), access during 
the study, data/specimen storage and length of time stored, shipment/transmission, and the 
plan for storage and final disposition at the conclusion of the study. Describe any data 
agreements in place for accessing data within and/or outside of your institution (e.g., Data 
Sharing Agreement, Data Use Agreement, Business Agreements, etc.) 
 
The consent form, baseline questionnaire, CBT outcomes, and pre-ACFT / post-ACFT self-efficacy 
forms will all be hard copy acquired. The post-ACFT injury case report form will be electronically 
acquired through Qualtrics, a secure electronic survey application. All of the case report forms 
(hard copy and electronic) will require the participants name on them. No subject ID will be 
included on these forms to remain in compliance with human research protections guidelines. 
Once the hard copy case report forms are collected, the study data will be transcribed into an 
electronic spreadsheet where the participant will only be identified by their assigned subject ID. 
Theonly document (electronic or hard copy) linking the subject ID and the participant name will 
be the electronic master subject list. The hard copy case report forms with participant names on 
them will all be stored together in a folder with the participant's consent form. Participant folders 
will be stored together in a locked filing cabinet, behind locked doors, in a CAC card protected 
building. All electronic files will be stored on DoD-server, CAC card protected computers. Only 
the PI and Al's will have access to the physical and electronic participant files. 
 
Performance information received from the Department of Military Instruction (DMI) is not 
considered private health information, but will include personnel identifiers. The information, to 
include copies of ACFT scorecards, will be collected from the DMI following the ACFT and stored 
I 

with the rest of the participants hard copy CRFs containing personnel identifiers. In addition, the 
researchers will collect outcomes data from the DMI (CBT and task-specific event performance 
outcomes data) via secure access to department databases and/or via encrypted emails or an 
encrypted drop box. 
When we are ready for data analysis, we will subsequently collect injury information, number of 
days on profile for each subject for up to 9 weeks following cadet basic training. Subject number 
of days on profile will be combined with the previously de-identified study data on a spreadsheet 
for analysis. The spreadsheet data will be password and firewall-protected. There are no planned 
linkages with external databases, nor is transmission of the data for collaborative use 
anticipated. The PI will keep a master spreadsheet that links subject names with their unique 
identification number on a government computer assigned to the Pl. The computer is password 
and CAC-card protected, and the system is firewall protected. This document will not be shown 
to anyone except for the investigators in this study or governmental agencies only in accordance 
with federal law. All research data and forms (both paper and electronic) will only be accessible 
by authorized study staff, the local IRB, and applicable governmental agencies as part of their 
duties and in accordance with federal law. These duties include making sure that research 
participants are protected. 
10.15 Managing Data (Data Management and/or Sharing Plan) and/or Human Biological Specimens for 
Future Research: 
If the study involves collecting, storing, or banking human specimens, data, or documents 
(either by the Investigator or through an established repository) for FUTURE research, address. 
How the specimens/data will be used, where and how data/specimens will be stored (including 
shipping procedures, storage plan, etc.), whether and how consent will be obtained, procedures 
that will fulfill subjects' request as stated in the consent, whether subjects may withdraw their 
data/specimens from storage, whether and how subjects may be recontacted for future research 
and given the option to decline, whether there will be genetic testing on the specimens, who will 
have access to the data/specimens, and the linkage, the length of time that data/specimens will 
be stored and conditions under which data/specimens will be destroyed. 
All records containing HIPAA PHI will be maintained for a period of 6 years at which time they 
will be destroyed by securely shredding. The master list connecting unique study ID to 
participant identifiers will be destroyed upon study closure. De-identified research data will be 
maintained indefinitely. 
Any data submitted to an approved agency for review will be linked only to the subject 
identification number and not the personal identity of the participant (ie, protected health 
information such as name, SSN, address, phone number, etc). If the data are used in scholarly 
presentations or journal articles, the investigators will protect the anonymity of individual 
patients and will report only aggregate data (e.g. group means) where appropriate. Participants 
will not be specifically identified in any publication or presentation of research results. No data 
sharing/use agreements are necessary or will be utilized. 
 
11.0 
Statistical/Data Analysis Plan 
 
 
11.1 Statistical Considerations: 
 
 
List the statistical methods to be used to address the primary and secondary objectives, specific 
aims, and/or research hypotheses. Explain how missing data and outliers will be handled in the 
analysis. The analysis plan should be consistent with the study objectives. Include any sub- 
group analyses (e.g., gender or age group). Specify statistical methods and variables for each 
analysis. Describe how confounding variables will be controlled in the data analysis 
 
To determine the effect of low back pain education (cautionary vs resiliency) on deadlift 
performance (weight lifted), we will use ANOVA and planned comparison analysis if between- 
group differences are found between groups. 
 
To determine the effect of low back pain education on deadlift self-efficacy, we will analyze 
change scores with a one-way ANOVA and planned comparisons if significant. 

To determine the effect of low back pain education on perceived spine vulnerability, we will 
analyze change scores with a one-way ANOVA and planned comparisons if significant. 
 
Our study design accounts for some confounding factors by utilizing randomization. Potentially 
confounding variables should be balanced between groups. We will test groups at baseline to 
ensure they are similar among important characteristics. Furthermore, characteristics that are 
different among groups at baseline or that appear to be influential on load lifted will be included 
in the ANOVA model as a covariate to control for and test for potential confounding. 
 
 
 
11.2 Sample Size: 
 
1200 participants 
 
I 
 
11.3 Total number of subjects requested (including records and specimens): 
 
1200 
I 
11.4 If youare recruiting by study arm, please identify the arms of the study and how many subjects will 
be enrolled in each arm 
 
N/A ---- 
I 
 
11.5 Please provide a justification for your sample size 
 
 
We have powered this study to determine a between-group difference of 5kg. This is equivalent 
to an effect size of d=.10 given a standard deviation of 23kg (available from previously collected 
data in this lab). We used G*Power 3.0 with power at .80 to calculate a total sample size of 969 
subjects (323 per group). We will therefore attempt to recruit 1200 participants, allowing for 
20% injury or attrition which might prevent subjects from completing the MDL event during CBT 
ACFT. 
 
 
11.6 Data Analysis Plan: Complete description: Background, Objectives, Design, Step by Step how the 
project is going to be done, Data analysis plan: 
 
 
1. Determine if general self-efficacy is a predictor of injury during CBT by performing a Kaplan-Meier Survival 
Curve, a single assessment (Cadet General Self-Efficacy Assessment), analysis of the Defense Medical 
Surveillance System (DMSS) and a follow-up self-reported injury assessment. 
1. Independent Variable: Cadet General Self-Efficacy score 
2. Dependent Variables: Injury report according to DMSS or self-reported 
 
2. Determine if task-specific self-efficacy is a predictor of injury during specific CBT events by performing a 
Kaplan-Meier Survival Curve, a single (or multiple) assessments of cadet task-specific self-efficacy, analysis of 
the Defense Medical Surveillance System (DMSS) and a follow-up self-reported injury assessment. 
1. Independent Variable: Cadet Task-Specific Self-Efficacy score 
2. Dependent Variables: Injury report according to DMSS or self-reported 
 
3. Determine if general self-efficacy is a predictor of performance during CBT by performing a multivariate 
regression between a single assessment (Cadet General Self-Efficacy Assessment) and multiple measures of 
performance during CBT including 1) successful completion (pass/fail), 2) Army Combat Fitness Test (ACFT) 
raw or calculated score, 3) Warrior Competition performance, 4) marksmanship score, 5) written exams, 6) 
swimming assessment and 7) any other individually graded events. 
1. Independent Variable: Cadet General Self-Efficacy score 
2. Dependent Variables: performance outcome by event- 1) successful completion (pass/fail), 2) 
Army Combat Fitness Test (ACFT) score, 3) Warrior Competition performance, 4) marksmanship 
score, 5) written exams, 6) swimming assessment and 7) any other individually graded events. 
 
4. Determine if task-specific self-efficacy is a predictor of performance during CBT by performing a 
multivariate regression between a single (or multiple) assessments of cadet task-specific self-efficacy, and 
multiple 

12.1 Subject Population: 
All incoming US Military Academy cadets, class of '26, attending cadet basic training in the 
summer of 2022 
12.2  AgeRange: 
Check all the boxes that apply. if the age range of potential subjects (specimens, records) does 
not match the range(s) selected, please specify in the text box. 
0-17 
18-24 
25-34 
C 35-44 
r 55-64 
C65-74 
0 75+ 
r 45-54 
12.3  Gender: 
 
measures of performance during CBT including 1) successful completion (pass/fail), 2) Army Combat Fitness 
Test (ACFT) raw or calculated score, 3) Warrior Competition performance, 4) marksmanship score, 5) written 
exams, 6) swimming assessment and 7) any other individually graded events. 
1. Independent Variable: task-specific self-efficacy scores by event 
2. Dependent Variables: performance outcome by event- 1) successful completion (pass/fail), 2) 
Army Combat Fitness Test (ACFT) score, 3) Warrior Competition performance, 4) marksmanship 
score, 5) written exams, 6) swimming assessment and 7) any other individually graded events. 
5. After completing CBT, determine which sources of self-efficacy (1) enacting mastery experiences, 2) 
vicarious experiences, 3) verbal persuasion, 4) physiological state, 5) affective state, 6) mental imagery) were 
the most influential on cadets' self-efficacy throughout CBT specific tasks including 1) successful completion 
(pass/fail), 2) Army Combat Fitness Test (ACFT) raw or calculated score, 3) Warrior Competition performance, 
4) marksmanship score, 5) written exams, 6) swimming assessment and 7) any other individually graded 
events by conducting a Chi-square test. 
1. Independent Variable: task-specific events 1) successful completion (pass/fail), 2) Army Combat 
Fitness Test (ACFT) score, 3) Warrior Competition performance, 4) marksmanship score, 5) written 
exams, 6) swimming assessment and 7) any other individually graded events. 
2. Dependent Variables: reported level of influence of each (6) source of self-efficacy. 
6. Determine the effect of low back pain education (cautionary vs resiliency) on deadlift performance (weight 
lifted). 
We will analyze this with MDL weight lifted as the dependent variable (one-way ANOVA), with a planned 
comparison analysis if significant differences are found between groups. 
7. Determine the degree of confidence cadets have in their ability to succeed at the MDL both before and after 
the education and MDL 
We will analyze if there is a main effect of time in the pre-to-post self-efficacy scores with a paired I-test. We will 
use multiple regressions to analyze the impact of self-efficacy scores on MDL performance. 
8. Determine the effect of low back pain education (cautionary vs resiliency) on deadlift self-efficacy. 
We will analyze change scores withone-way ANOVA with planned comparisons between groups if ANOVA is 
significant. 
9. Determine the effect of low back pain education (cautionary vs resiliency) on perceived spine vulnerability on 
a deadlift. 
We will analyze change scores withone-way ANOVA with planned comparisons between groups if ANOVA is 
significant. 
 
12.0 
Participant Information 
 

 
Male 
Female 
Cother 
12.4 Special categories, check all that apply 
C Minors /Children 
r Students 
r Employees - Civilian 
C Employees - Contractor 
D Resident/trainee 
Cadets /Midshipmen 
D Active Duty Military Personnel 
C Wounded Warriors 
r Economically Disadvantaged Persons 
r Educationally Disadvantaged Persons 
C Physically Challenged (Physical challenges include visual and/or auditory impairment) 
C Persons with Impaired Decisional Capacity 
C Prisoners 
D Pregnant Women, Fetuses, and Neonates 
C Non-English Speakers 
r International Research involving Foreign Nationals - Headquarters Review is necessary 
You must also consider the requirements of DoDI 3216.02, Enclosure 3, paragraphs 7.e. and 12. 
12.5  Inclusion Criteria: 
.. 
Criteria 
Inclusion criteria are cadets age 17-26 (cadets under the age of 18 are legally emancipated 
1 
therefore able to consent), those paiticipating in the ACFT, and speak and understand 
English 
12.6 Exclusion Criteria: 
.. 
Criteria 
No Criteria has been added to this Protocol 
 
13.0 
Recruitment and Consent 
 
 
13.1 Please describe the recruitment process, including how subjects will be ide 
the study. 
 
 
All 1,200 new Cadets will be recruited all together in an auditorium with a mass verbal 
explanation and handouts available for written explanation. Researchers will be dressed in 
professional civilian attire to prevent perceived authoritative influence due to higher milita 
rank. Cadets who do not wish to participate can decline participation. Participation is volun 
with no incentives offered for participating and those who opt out will receive no adverse 
ntified and selected for 
ry 
tary 
actions. 

13.2 Compensation for Participation: 
 
 
Participation is voluntary with no incentives offered for participating and those who opt out will 
receive no adverse actions. 
 
13.3 Please describe the pre-screening process. If no pre-screening, enter Not Applicable in the text editor 
 
 
Not applicable 
 
 
13.4 Consent Process: Revised Common Rule, Section 219.116: General requirements for informed 
consent, whether written or oral, are set forth in this paragraph and apply to consent obtained in 
accordance with the requirements set forth in paragraphs (b) through (d) of this section. Broad 
consent may be obtained in lieu of informed consent obtained in accordance with paragraphs (b) and 
(c) of this section only with respect to the storage, maintenance, and secondary research uses of 
identifiable private information and identifiable biospecimens. 
 
 
Are you requesting a waiver or alteration of informed consent? 
 
0  Yes  ® No 
 
Please explain the consent process: 
 
Researchers will obtain written consent from participants all at once. 
- 
 
13.S DoDI 3216.02 requires an ombudsman to be present during recruitment briefings when research 
involves greater than minimal risk and recruitment of Service members occurs in a group setting. If 
applicable, you may nominate an individual to serve as the ombudsman. 
 
 
0  N/A 
® Propose ombudsman 
 
Proposed ombudsman name, if the desired ombudsman is not in the system 
 
Kelly Channell 
 
I 
Please explain the ombudsman's role and responsibilities on this project 
 
In accordance with the KACH Policy for use of an Ombudsman, the Ombudsman will act as an 
impartial and objective advocate for human subjects participating in research (DODI 3216.02). 
He/she will ensure that cadets are not coerced in any way and that all of their question and/or 
concerns are answers. The Ombudsman will be present during the study recruitment and consent 
process to ensure voluntary involvement and that the research is presented in clear, adequate 
and accurate means. 
 
 
13.6  Withdrawal from Study Participation: 
 
 
Explain the process for withdrawal and specify whether or not the subjects will be given the 
opportunity to withdraw their data their data/specimens in the event they wish to withdraw from 
the study 
 
All participants will receive the researchers email address during the study description and 
consent briefing. To be removed, they just need to email the primary investigator to be removed 
from the study. 
 
 
14.0 
Risks and Benefits 
 
 
14.1 
Risks of Harm: 

 
Identify all research-related risks of harm to which the subject will be exposed for each research 
procedure or intervention as a result of participation in this study. Consider the risks of breach 
of confidentiality, psychological, legal, social, and economic risks as well as physical risks. Do 
not describe risks from standard care procedures; only describe risks from procedures done for 
research purposes 
The most likely risk of this study is a potential loss of privacy. We will protect subjects' privacy 
by labeling information only with a unique study ID number, and by keeping the link to these ID 
numbers in a password-protected database on a secure server which is only accessible by the 
principal investigator and designated research staff using CAC authentication. 
There is an inherent risk of injury during cadet basic training and during the ACFT, however this 
study does not increase or decrease that risk. Cadets who choose to participate in this study will 
have identical risk as cadets who choose not to participate. 
14.2 
Measures to Minimize Risks of Harm (Precautions, safeguards): 
For each research procedure or intervention, describe all measures to minimize and/or eliminate 
risk of harms to subjects and study personnel 
TI1e cautionaiy education provided to one of the groups is similai·to standat·d coaching advice 
offered to servicemembers before maximum deadlift testing or conducting an ACFT. However, in 
order to prevent perpetuating any participants' fear of spine vulnerability during deadlifts, we will 
consolidate best-evidence Sllllllllaty statements on how to maintain a healthy back as a cadet and 
beyond. All pa1ticipants will be given this inf01mation and provided an opportunity to speak with a 
licensed physical therapist about any concerns they might have about their back or lifting for the 
deadlift at a later date. 
14.3 
Confidentiality Protections (for research records, data and/or specimens): 
Describe in detail the plan to maintain confidentiality of the research data, specimens, and 
records throughout the study and at its conclusion (e.g., destruction, long term storage, or 
banking). Explain the plan for securing the data (e.g., useof passwords, encryption, secure 
servers, firewalls, and other appropriate methods). If data will be shared electronically with 
other team members/collaborators outside the institution, describe the method of transmission 
and safeguards to maintain confidentiality. Explain whether this study may collect information 
that State or Federal law requires to be reported to other officials or ethically requires action, e. 
g., child or spouse abuse 
All physical case report forms of the participants will be stored together in a locked filing cabinet 
which is secured behind a locked door in the Physical Therapy clinic that is located in a CAC 
protected building. The case report forms will be stored with the consent form of participants due 
to them containing personally identifiable information (first and last name). 
Following the completion of data collection the study data collected on physical case report forms 
will be transcribed into password protected electronic spreadsheets, that will be stored on CAC 
protected, firewall secured, DoD server computers only accessible to the PI and AI's. The data 
spreadsheets will identify participants by subject ID and not by name. The master subject list is 
the only file that will connect subject ID and participant name. 
There are no planned linkages with external databases, nor is transmission of the data for 
collaborative use anticipated. The PI will keep a master spreadsheet that links subject names 
with their unique identification number on a government computer assigned to the PI. The 
computer is password and CAC-card protected, and the system is firewall protected. This 
electronic spreadsheets will not be shown to anyone except for the investigators in this study or 
governmental agencies only in accordance with federal law. All research data and forms (both 
paper and electronic) will only be accessible by authorized study staff, the local IRB, and 

applicable governmental agencies as part of their duties and in accordance with federal law. 
These duties include making sure that research participants are protected. 
14.4 
Potential Benefits: 
Describe any real and potential benefits of the research to the subject and any potential benefits 
to a specific community or society 
If the individuals in the research are considered experimental subjects (per 10 USC 980}, and 
they cannot provide their own consent, the protocol must describe the intent to directly benefit 
all subjects 
The outcomes of this study could benefit the military community if self-efficacy proves to be an 
adaptable characteristic that is correlated with injury during cadet basic training. Planning 
training to include self-efficacy development could therefore help prevent future injury in cadets 
and U.S. Army Soldiers. 
There is currently an emphasis in Army Doctrine {FM 7-22) on form/technique for events on the ACFT, 
especially the maximum deadlift (MDL) and the prevention of lower back injuries. The rationale behind this is 
due to the perception that breakdowns in form during the deadlifl lead to injuries, however, the research does 
not support this. Specifically, the research is unclear regarding the position of the spine while deadlifting- 
neutral vs flexed. Our results could impact future DoD publications regarding technique on the MDL and de- 
emphasize the role of a rounded spine as a safety concern. 
14.S 
Privacy for Subjects: 
Describe the measures to protect subject's privacy during recruitment, the consent process, and 
all research activities, etc. 
Like many biomedical research protocols considered by IRBs, the protection of confidentiality is a 
significant concern. In order to protect confidentiality, all participants will be assigned a unique 
ID at the time of record review. All research related data will only be labeled and stored with 
each participant's unique ID. Furthermore, for the current study, only the immediate research 
team will have access to the data associated with this project. The linkage between the unique 
ID number and master participant list will be maintained electronically on the physical therapy 
server which is limited to authorized KACH users in the physical therapy department and requires 
CAC authentication. 
14.6 
Incidental or Unexpected Findings: 
Describe the plan to address incidental findings and unexpected findings about individuals from 
screening to the end of the subject's participation in the research. In cases where the subject 
could possibly benefit medically or otherwise from the information, state whether or not the 
results of screening, research participation, research tests, etc., will be shared with subjects or 
their primary care provider. State whether the researcher is obligated or mandated to report 
results to appropriate military or civilian authorities and explain the potential impact on the 
subject 
All participants will be assured that any injury information that they share with us is private and 
under the same protections as any other medical information. The information will not be shared 
with USMA administrators, faculty or cadre and will no way change the admission status or 
training status. We do not anticipate any unexpected findings that could be detrimental to 
subject. Any medical concerns will be brought up privately between the primary investigator and 
the cadet directly if needed. 

 
 
15.0 
Study Monitoring 
 
 
15.1 Your study requires either Data and Safety Monitoring Plan (DSMP) or a Data and Safety Monitoring 
Board (DSMB). 
0  DSMP 
0  DSMB 
0 Both 
@ Not Applicable 
 
16.0 
Reportable Events 
 
 
16.1 Reportable Events: Consult with the research office at your institution to ensure requirements are 
met. Describe plans for reporting unexpected adverse events and unanticipated problems. Address 
how unexpected adverse events will be identified, who will report, how often adverse events and 
unanticipated problems will be reviewed to determine if any changes to the protocol or consent form 
are needed and the scale that will be used to grade the severity of the adverse event. 
Consult with the research office at your institution to ensure requirements are met 
• Describe plans for reporting expected adverse events. Identify what the expected adverse 
events will be for this study, describe the likelihood (frequency, severity, reversibility, short- 
term management and any long-term implications of each expected event) 
• Describe plans for reporting unexpected adverse events and unanticipated problems. Address 
how unexpected adverse events will be identified, who will report, how often adverse events and 
unanticipated problems will be reviewed to determine if any changes to the research protocol or 
consent form are needed and the scale that will be used to grade the severity of the adverse 
event 
Adverse events: Events which are not serious are reported on the Annual Progress Report (APR) 
or Continuing Review Report (CRR) of the protocol. 
Serious Adverse Events: The PI, within one working day, will report all serious adverse events 
occurring in participants enrolled at KACH. the investigator must contact the HPD within one 
business day of discovery. HPD will inform the NMCP HPD, who will notify the IRB Chair via 
email and phone call. The HPD will report the event to the IO as soon as possible after 
determining the event is an SAE or unanticipated problem. The HPD will notify DHA within 3 days 
that an event is under investigation and follow up by email. A Reportable Event Form and 
supporting documentation must be submitted to the HPD within five business days and will be 
forwarded to the IRB for review at the next available meeting. 
Unexpected (but not serious) adverse events occurring in participants enrolled at KACH which, in 
the opinion of the PI, are possibly related to participation in the protocol will be reported by the 
PI within three working days to the IRB using the same procedure. 
All UPIRTSOs, UADEs, and SAEs that are unexpected and determined to be at least possibly 
related or definitely related to research participation will be promptly reported by telephone or 
via email to the IRB. A complete report will follow the initial notification within three (3) business 
days. 
Minor Deviations must be reported to the IRB at the time of continuing review or project closure. 
Major Deviations should be promptly reported to the HPA and IRB and in NLT three days. 
 
17.0 
Equipment/non-FDA Regulated Devices 

18.1 Will any drugs, dietary supplements, biologics, or devices be utilized in this study? 
C Drugs 
0 Dietary Supplements 
0  Biologics 
0  Devices 
l;i N/A 
18.S Sponsor (organization/institution/company): 
P° N/A 
If applicable, provide sponsor contact information: 
17.1 Does the study involve the use of any unique non-medical devices/equipment? 
0 
Yes  @ No 
 
18.0 
FDA-Regulated Products 
 
 
 
19.0 
Research Registration Requirements 
 
 
19.1 ClinicalTrials.gov Registration: 
0 Registration is not required 
@ Registration pending 
0  Registration complete 
19.2 Defense Technical Information Center Registration (Optional): 
@ Registration is not required 
0 Registration pending 
0 Registration complete 
 
20.0 
References and Glossary 
 
 
20.1  References: 
 
 
Alemany, J. A., Pierce, J. R., Bornstein, D. B., Grier, T. L., Jones, B. H., & Glover, S. H. (2021). 
Comprehensive Physical Activity Assessment During U.S. Army Basic Combat Training. Journal of 
Strength and Conditioning Research, Publish Ahead of Print. https:/ /doi.org/10.1519/JSC. 
0000000000004114 
 
Almeida, P. L., Olmedilla, A., Rubio, V. J., & Palou, P. (n.d.). Psychology in the realm of sport 
injury: What it is all about. Revista de Psicologfa Del Deporte., 23, 6. 

 
Army Public Health Center. (2021). Health of the Force 2020. Army Public Health Center. https:/ 
/ phc.amedd.a rmy.mii/ Periodical0/o20Library/ 2020-hof-report.pdf 
Bandura, A. (2006). Guide for Construction Self-Efficacy Scales. In Self-Efficacy Beliefs of 
Adolescents (Vol. 5, pp. 307-337). Information Age Publishing. 
Bandura, A. (1977). Self-efficacy: Toward a unifying theory of behavioral change. Psychological 
Review,  84(2),  191-215.  https://doi.org/10.1037/0033-295X.84.2.191 
Bandura, A. (1982). Self-efficacy mechanism in human agency. American Psychologist, 37(2), 
122-147.  https://doi.org/10.1037 /0003-066X.37.2.122 
Beattie, S., Fakehy, M., & Woodman, T. (2014). Examining the moderating effects of time on 
task and task complexity on the within person self-efficacy and performance relationship. Psycho/ 
ogy of Sport and Exercise, 15(6), 605-610. https:/ /doi.org/ 10.1016/j.psychsport. 
2014.06.007 
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20.2  Abbreviations and Acronyms: 
USMA: United States Military Academy 
CBT: Cadet Basic Training 
MSK-I: Musculoskeletal Injury 
SANE: Single Assessment Numerical Evaluation 
CIITS: Cadet Injury and Illness Tracking System 
ACFT: Army Combat Fitness Test 
MDL: Maximum Deadlift 
AHLTA: Armed Forces Health Longitudinal Technology Application 
DMSS: Defense Medical Surveillance System