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Trial record 2 of 2 for:    16888612 [PUBMED-IDS]

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
Sponsor:
Information provided by (Responsible Party):
Cherrie B. Boyer, PhD, University of California, San Francisco

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
Enrollment 933

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Preventing Sexual Health Risks Improving Nutrition, Fitness and Injury Prevention
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
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.
Arm/Group Title Preventing Sexual Health Risks Improving Nutrition, Fitness and Injury Prevention Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 540 393 933
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 540 participants 393 participants 933 participants
20.77  (3.121) 20.77  (3.124) 20.77  (3.121)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 540 participants 393 participants 933 participants
Female
68
  12.6%
56
  14.2%
124
  13.3%
Male
472
  87.4%
337
  85.8%
809
  86.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 540 participants 393 participants 933 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 540 participants 393 participants 933 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 540 participants 393 participants 933 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 540 participants 393 participants 933 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  
Mean (Standard Deviation)
Unit of measure:  Sex partners
Number Analyzed 540 participants 393 participants 933 participants
10.09  (26.300) 8.39  (10.272) 9.36  (20.967)
Number of pregnancies (males and females)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 540 participants 393 participants 933 participants
None
397
  73.5%
293
  74.6%
690
  74.0%
1
78
  14.4%
58
  14.8%
136
  14.6%
2
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 540 participants 393 participants 933 participants
None
428
  79.3%
317
  80.7%
745
  79.8%
1
68
  12.6%
50
  12.7%
118
  12.6%
2
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 540 participants 393 participants 933 participants
None
512
  94.8%
363
  92.4%
875
  93.8%
1
23
   4.3%
15
   3.8%
38
   4.1%
2
5
   0.9%
8
   2.0%
13
   1.4%
3
0
   0.0%
2
   0.5%
2
   0.2%
Missing Data
0
   0.0%
5
   1.3%
5
   0.5%
1.Primary Outcome
Title Incidence of Sexually Transmitted Infections and the Self-reported Numbers of Unintended Pregnancies
Hide Description [Not Specified]
Time Frame 6 to 9 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No data were collected from participants. Participants only attended intervention sessions.
Arm/Group Title Preventing Sexual Health Risks Improving Nutrition, Fitness and Injury Prevention
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Self-reported Behavioral Measures Related to STI/HIV Prevention
Hide Description [Not Specified]
Time Frame 6 to 9 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No data were collected from participants. Participants only attended intervention sessions.
Arm/Group Title Preventing Sexual Health Risks Improving Nutrition, Fitness and Injury Prevention
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame This was a behavioral education intervention and adverse event data were collected after each intervention session.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Preventing Sexual Health Risks Improving Nutrition, Fitness and Injury Prevention
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Preventing Sexual Health Risks Improving Nutrition, Fitness and Injury Prevention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/540 (0.00%)   0/393 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Preventing Sexual Health Risks Improving Nutrition, Fitness and Injury Prevention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/540 (0.00%)   0/393 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Preventing Sexual Health Risks Improving Nutrition, Fitness and Injury Prevention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/540 (0.00%)   0/393 (0.00%) 
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
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