Trial Outcomes & Findings for Preventing Health Damaging Behaviors in Male and Female Army Recruits (NCT NCT01234103)
NCT ID: NCT01234103
Last Updated: 2017-08-25
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
933 participants
Primary outcome timeframe
6 to 9 months
Results posted on
2017-08-25
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
542
|
391
|
|
Overall Study
COMPLETED
|
542
|
391
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preventing Health Damaging Behaviors in Male and Female Army Recruits
Baseline characteristics by cohort
| Measure |
Preventing Sexual Health Risks
n=540 Participants
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
n=393 Participants
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
n=933 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.77 years
STANDARD_DEVIATION 3.121 • n=5 Participants
|
20.77 years
STANDARD_DEVIATION 3.124 • n=7 Participants
|
20.77 years
STANDARD_DEVIATION 3.121 • n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
472 Participants
n=5 Participants
|
337 Participants
n=7 Participants
|
809 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
84 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
455 Participants
n=5 Participants
|
325 Participants
n=7 Participants
|
780 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
28 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/Black
|
115 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino/a
|
84 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian/White
|
279 Participants
n=5 Participants
|
206 Participants
n=7 Participants
|
485 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other/Mixed Race
|
26 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing Data
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Marital Status
Single/Never Married
|
460 Participants
n=5 Participants
|
337 Participants
n=7 Participants
|
797 Participants
n=5 Participants
|
|
Marital Status
Married
|
76 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Marital Status
Separated/Divorce
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Marital Status
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
5 or more drinks of alcohol on 1 occassion-past 3 months
No alcohol past 3 months
|
366 Participants
n=5 Participants
|
246 Participants
n=7 Participants
|
612 Participants
n=5 Participants
|
|
5 or more drinks of alcohol on 1 occassion-past 3 months
Never
|
41 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
5 or more drinks of alcohol on 1 occassion-past 3 months
Once/month or less
|
59 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
5 or more drinks of alcohol on 1 occassion-past 3 months
2-3 times/month
|
26 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
5 or more drinks of alcohol on 1 occassion-past 3 months
1 or more times/week
|
44 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
5 or more drinks of alcohol on 1 occassion-past 3 months
Missing
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Number of sex partners -ever
|
10.09 sex partners
STANDARD_DEVIATION 26.300 • n=5 Participants
|
8.39 sex partners
STANDARD_DEVIATION 10.272 • n=7 Participants
|
9.36 sex partners
STANDARD_DEVIATION 20.967 • n=5 Participants
|
|
Number of pregnancies (males and females)
None
|
397 Participants
n=5 Participants
|
293 Participants
n=7 Participants
|
690 Participants
n=5 Participants
|
|
Number of pregnancies (males and females)
1
|
78 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Number of pregnancies (males and females)
2
|
37 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Number of pregnancies (males and females)
3-5
|
23 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Number of pregnancies (males and females)
Missing Data
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Number of pregnancies unintended
None
|
428 Participants
n=5 Participants
|
317 Participants
n=7 Participants
|
745 Participants
n=5 Participants
|
|
Number of pregnancies unintended
1
|
68 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Number of pregnancies unintended
2
|
26 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Number of pregnancies unintended
3-5
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Number of pregnancies unintended
Missing Data
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sexually transmitted infection diagnosed-ever
None
|
512 Participants
n=5 Participants
|
363 Participants
n=7 Participants
|
875 Participants
n=5 Participants
|
|
Sexually transmitted infection diagnosed-ever
1
|
23 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sexually transmitted infection diagnosed-ever
2
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sexually transmitted infection diagnosed-ever
3
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sexually transmitted infection diagnosed-ever
Missing Data
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 to 9 monthsPopulation: No data were collected from participants. Participants only attended intervention sessions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 to 9 monthsPopulation: No data were collected from participants. Participants only attended intervention sessions.
Outcome measures
Outcome data not reported
Adverse Events
Preventing Sexual Health Risks
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Improving Nutrition, Fitness and Injury Prevention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Cherrie B. Boyer, PhD
University of California, San Francisco
Phone: 4154762184
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place