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Preventing Health Damaging Behaviors in Male and Female Army Recruits

This study has been terminated.
(Due to lack of continue funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01234103
First Posted: November 4, 2010
Last Update Posted: August 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cherrie B. Boyer, PhD, University of California, San Francisco
Results First Submitted: August 22, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Sexually Transmitted Infection (STI) Prevention
Unintended Pregnancy Prevention
Sexual Risk Reduction
Alcohol and Other Substance Use Prevention
Intimate Partner Violence Prevention
Intervention: Behavioral: Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Preventing Sexual Health Risks

The over goal is to prevent STIs, unintended pregnancies, and related behaviors including sexual risk, alcohol and other substance misuse

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.

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

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.


Participant Flow:   Overall Study
    Preventing Sexual Health Risks   Improving Nutrition, Fitness and Injury Prevention
STARTED   542   391 
COMPLETED [1]   542   391 
NOT COMPLETED   0   0 
[1] Each was enrolled at baseline, completed all intervention sessions, but no follow-up sessions.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Preventing Sexual Health Risks

The over goal is to prevent STIs, unintended pregnancies, and related behaviors including sexual risk, alcohol and other substance misuse

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.

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

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.

Total Total of all reporting groups

Baseline Measures
   Preventing Sexual Health Risks   Improving Nutrition, Fitness and Injury Prevention   Total 
Overall Participants Analyzed 
[Units: Participants]
 540   393   933 
Age 
[Units: Years]
Mean (Standard Deviation)
 20.77  (3.121)   20.77  (3.124)   20.77  (3.121) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      68  12.6%      56  14.2%      124  13.3% 
Male      472  87.4%      337  85.8%      809  86.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      84  15.6%      67  17.0%      151  16.2% 
Not Hispanic or Latino      455  84.3%      325  82.7%      780  83.6% 
Unknown or Not Reported      1   0.2%      1   0.3%      2   0.2% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
American Indian      7   1.3%      7   1.8%      14   1.5% 
Asian/Pacific Islander      28   5.2%      10   2.5%      38   4.1% 
African American/Black      115  21.3%      83  21.1%      198  21.2% 
Hispanic/Latino/a      84  15.6%      67  17.0%      151  16.2% 
Caucasian/White      279  51.7%      206  52.4%      485  52.0% 
Other/Mixed Race      26   4.8%      19   4.8%      45   4.8% 
Missing Data      1   0.2%      1   0.3%      2   0.2% 
Marital Status 
[Units: Participants]
Count of Participants
     
Single/Never Married      460  85.2%      337  85.8%      797  85.4% 
Married      76  14.1%      50  12.7%      126  13.5% 
Separated/Divorce      3   0.6%      6   1.5%      9   1.0% 
Missing      1   0.2%      0   0.0%      1   0.1% 
5 or more drinks of alcohol on 1 occassion-past 3 months 
[Units: Participants]
Count of Participants
     
No alcohol past 3 months      366  67.8%      246  62.6%      612  65.6% 
Never      41   7.6%      21   5.3%      62   6.6% 
Once/month or less      59  10.9%      63  16.0%      122  13.1% 
2-3 times/month      26   4.8%      32   8.1%      58   6.2% 
1 or more times/week      44   8.1%      27   6.9%      71   7.6% 
Missing      4   0.7%      4   1.0%      8   0.9% 
Number of sex partners -ever 
[Units: Sex partners]
Mean (Standard Deviation)
 10.09  (26.300)   8.39  (10.272)   9.36  (20.967) 
Number of pregnancies (males and females) 
[Units: Participants]
Count of Participants
     
None      397  73.5%      293  74.6%      690  74.0% 
    78  14.4%      58  14.8%      136  14.6% 
    37   6.9%      23   5.9%      60   6.4% 
3-5      23   4.3%      16   4.1%      39   4.2% 
Missing Data      5   0.9%      3   0.8%      8   0.9% 
Number of pregnancies unintended 
[Units: Participants]
Count of Participants
     
None      428  79.3%      317  80.7%      745  79.8% 
    68  12.6%      50  12.7%      118  12.6% 
    26   4.8%      14   3.6%      40   4.3% 
3-5      11   2.0%      7   1.8%      18   1.9% 
Missing Data      7   1.3%      5   1.3%      12   1.3% 
Sexually transmitted infection diagnosed-ever 
[Units: Participants]
Count of Participants
     
None      512  94.8%      363  92.4%      875  93.8% 
    23   4.3%      15   3.8%      38   4.1% 
    5   0.9%      8   2.0%      13   1.4% 
    0   0.0%      2   0.5%      2   0.2% 
Missing Data      0   0.0%      5   1.3%      5   0.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Incidence of Sexually Transmitted Infections and the Self-reported Numbers of Unintended Pregnancies   [ Time Frame: 6 to 9 months ]

2.  Secondary:   Self-reported Behavioral Measures Related to STI/HIV Prevention   [ Time Frame: 6 to 9 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Cherrie B. Boyer, PhD
Organization: University of California, San Francisco
phone: 4154762184
e-mail: Cherrie.Boyer@ucsf.edu


Publications:
Boyer CB, Shafer MA, Moncada J, Schachter J, Shaffer RA, Brodine SK. Sociodemographic, behavioral, and clinical factors associated with STDs in a national sample of women entering the US military. ISSTDR: Sexually Transmitted Infections. 2001:241-246.
Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2000. Atlanta, GA: Division of Sexually Transmitted Diseases, National Center for HIV, STD and TB Prevention; 2001.
United States Department of Health and Human Services. Alcohol research & health: highlights from the tenth special report to Congress, Health risks and benefits of alcohol consumption. Vol 24. Washington, DC: U.S. Government Printing Office; 2000.
Boyer CB, Shafer MA. Preventing STDs and unplanned pregnancies: a cognitive-behavioral intervention for young women entering the U.S. military. Journal of Adolescent Health. 2003;32(2):129.


Responsible Party: Cherrie B. Boyer, PhD, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01234103     History of Changes
Other Study ID Numbers: W81XWH-04-1-0159
First Submitted: November 3, 2010
First Posted: November 4, 2010
Results First Submitted: August 22, 2017
Results First Posted: August 25, 2017
Last Update Posted: August 25, 2017