Preventing Health Damaging Behaviors in Male and Female Army Recruits
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ClinicalTrials.gov Identifier: NCT01234103 |
Recruitment Status
:
Terminated
(Due to lack of continue funding)
First Posted
: November 4, 2010
Results First Posted
: August 25, 2017
Last Update Posted
: August 25, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sexually Transmitted Infection (STI) Prevention Unintended Pregnancy Prevention Sexual Risk Reduction Alcohol and Other Substance Use Prevention Intimate Partner Violence Prevention | Behavioral: Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits | Not Applicable |
The primary hypotheses to be tested in this research are as follows. AIT soldiers participating in the experimental STI/UIP prevention intervention will: (a) have increased knowledge about the risk factors for and prevention of STIs, UIPs, alcohol and other substances, and intimate partner violence (IPV); (b) be more highly motivated to change risk behaviors associated with STIs and UIPs; (c) have higher levels of skills to prevent risk behaviors associated with STIs and UIPs and skills; (d) engage in more health promoting behaviors and fewer risk behaviors associated with STIs and UIPs, and (e) have fewer STIs and UIPs post-intervention compared with AIT solders who participate in a comparable control intervention focused on increasing healthy eating, maintaining physical fitness, and preventing fitness-related injuries.
The overall goal of this research is to evaluate the effectiveness a cognitive-behavioral skills-building intervention to prevent risk for and acquisition of STIs and UIPs and will seek to reduce a number of their associated risk factors including, alcohol misuse, other substance use, IPV in AIT soldiers. Specifically, we will evaluate whether AIT soldiers who participate in the experimental intervention entitled, Staying Safe and in Control: Increasing Knowledge and Building Skills to Prevent Sexually Transmitted Infections and Unintended Pregnancies will reduce their risk for and acquisition of STIs, UIPs and their associated sexual and substance use behaviors compared with AIT soldiers who undergo the control intervention entitled, Fit You: Practical Tools for Healthy Eating, Physical Fitness, and Injury Prevention. This intervention will focus primarily on promoting healthy eating, maintaining physical fitness, and preventing work-related and exercise injury.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 933 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Preventing Health Damaging Behaviors in Male and Female Army Recruits |
Study Start Date : | September 2010 |
Actual Primary Completion Date : | March 2013 |
Actual Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Preventing sexual health risks
The over goal is to prevent STIs, unintended pregnancies, and related behaviors including sexual risk, alcohol and other substance misuse
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Behavioral: Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits
Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors.
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Improving nutrition, fitness and injury prevention
The goals are: (1) maintain and improve nutrition and physical fitness through healthier lifestyle and food choices; (2) reduce the risk of sports or physical training injuries and learning how to treat injuries; and (3) Learn to recognize stress and the steps you can take to reduce stress
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Behavioral: Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits
Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors.
|
- Incidence of Sexually Transmitted Infections and the Self-reported Numbers of Unintended Pregnancies [ Time Frame: 6 to 9 months ]
- Self-reported Behavioral Measures Related to STI/HIV Prevention [ Time Frame: 6 to 9 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- All participants will be 18 years of age or older, will be fluent in English, and able to provide written, informed consent.
Exclusion Criteria:
- AIT soldiers under the age of 18 will be excluded since it will be difficult to obtain parental consent. We anticipate that this exclusion will be rare.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01234103
United States, South Carolina | |
Fort Jackson Advance Individual Training Units | |
Columbia, South Carolina, United States, 29044 |
Principal Investigator: | Cherrie B Boyer, PhD | University of California, San Francisco |
Publications:
Responsible Party: | Cherrie B. Boyer, PhD, Professor of Pediatrics, University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT01234103 History of Changes |
Other Study ID Numbers: |
W81XWH-04-1-0159 |
First Posted: | November 4, 2010 Key Record Dates |
Results First Posted: | August 25, 2017 |
Last Update Posted: | August 25, 2017 |
Last Verified: | August 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Cherrie B. Boyer, PhD, University of California, San Francisco:
sexually transmitted infection sexual risk HIV young adults cognitive-behavioral intervention |
Additional relevant MeSH terms:
Sexually Transmitted Diseases Infection Virus Diseases Genital Diseases, Male Genital Diseases, Female |