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Preventing Health Damaging Behaviors in Male and Female Army Recruits

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Department of Defense.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Department of Defense
ClinicalTrials.gov Identifier:
NCT01234103
First received: November 3, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted

November 3, 2010
November 3, 2010
September 2010
September 2012   (final data collection date for primary outcome measure)
incidence of sexually transmitted infections and the self-reported numbers of unintended pregnancies [ Time Frame: 6 to 9 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
self-reported behavioral measures related to STI/HIV prevention [ Time Frame: 6 to 9 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Preventing Health Damaging Behaviors in Male and Female Army Recruits
Preventing Health Damaging Behaviors in Male and Female Army Recruits

Health damaging (risk) behaviors of young military personnel are reflections of health problems facing all young people in the U.S. Military life presents opportunities and challenges that may both protect against and place young troops at risk for health damaging behaviors. Challenges for maintaining a healthy armed force include high rates of sexually transmitted infections (STIs), unintended pregnancies (UIPs), misuse of alcohol and other substances. The common thread through these negative health outcomes is volitional behavior. Such behaviors do not only result in illness or injury, but also negatively impact performance of military duties and threaten military readiness. Despite military leadership in setting standards and policies regarding professional behavior and universal health care for preventing and eliminating such negative health outcomes, many health problems remain. Building on our previous military research, we will evaluate the effectiveness a cognitive-behavioral, skills-building intervention to prevent and reduce young troops' 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, and victimization due to IPV in male and female U.S. Army soldiers who are receiving Advance Individual Training (AIT) in Fort Jackson, SC.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Sexually Transmitted Infection (STI) Prevention
  • Unintended Pregnancy Prevention
  • Sexual Risk Reduction
  • Alcohol and Other Substance Use Prevention
  • Intimate Partner Violence Prevention
Behavioral: Staying Safe & In Control: Increasing Knowledge and Building Skills to Prevent STIs and Unintended Pregnancy
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
Experimental: Cognitive-behavioral intervention
To prevent STIs, unintended pregnancies, and related behaviors including sexual risk and alcohol and other substance use
Intervention: Behavioral: Staying Safe & In Control: Increasing Knowledge and Building Skills to Prevent STIs and Unintended Pregnancy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
September 2013
September 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact: Cherrie B Boyer, PhD 415-476-9620 boyerc@peds.ucsf.edu
Contact: Anthony Kung, BA 415-502-4689 kunga@peds.ucsf.edu
United States
 
NCT01234103
W81XWH-04-1-0159
Yes
Cherrie B. Boyer, PhD, University of California San Francisco
Department of Defense
Not Provided
Principal Investigator: Cherrie B Boyer, PhD University of California, San Francisco
Department of Defense
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP