Trial Outcomes & Findings for The Health Check-Up for Expectant Moms (NCT NCT02120716)
NCT ID: NCT02120716
Last Updated: 2018-12-12
Results Overview
CIAS Satisfaction Measure (adapted from Ondersma et al., 2005). Self-report instrument assessing the extent to which participants found the software acceptable. Mean ratings on items including Likeability and Ease of use; scores range from 1 (low) to 5 (high) in satisfaction. HCEM Satisfaction Measure. Self-report instrument assessing the extent to which participants found specific components of the HCEM intervention acceptable (e.g., videos, resources, information); scores range from 1 (low) to 7 (high) in satisfaction.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
4 month follow up
Results posted on
2018-12-12
Participant Flow
Participant milestones
| Measure |
Health Check-Up of Expectant Moms
Participants receive computer delivered intervention (Health Check-up for Expectant Moms)
Health Check-Up for Expectant Moms: Participants randomly assigned to the treatment condition will receive a 60-minute brief intervention on the Tablet PC after the baseline assessment. The software will personalize the intervention content based on the current risk status of each participant and will include a plan addressing endorsed risks. Within one month of baseline, there will be a 15-20 minute, computer-delivered booster session reviewing the personalized plan and identifying barriers in the reduction or risks and/or meeting the goals in the plan.
|
Time and Attention Matched Control Group
Participants will be presented a brief series of videos of television shows, with subsequent ratings of subjective preference
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
19
|
|
Overall Study
COMPLETED
|
30
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Health Check-Up for Expectant Moms
Baseline characteristics by cohort
| Measure |
Health Check-Up of Expectant Moms
n=31 Participants
Participants receive computer delivered intervention (Health Check-up for Expectant Moms)
Health Check-Up for Expectant Moms: Participants randomly assigned to the treatment condition will receive a 60-minute brief intervention on the Tablet PC after the baseline assessment. The software will personalize the intervention content based on the current risk status of each participant and will include a plan addressing endorsed risks. Within one month of baseline, there will be a 15-20 minute, computer-delivered booster session reviewing the personalized plan and identifying barriers in the reduction or risks and/or meeting the goals in the plan.
|
Time and Attention Matched Control Group
n=19 Participants
Participants will be presented a brief series of videos of television shows, with subsequent ratings of subjective preference
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.1 Years
STANDARD_DEVIATION 5.79 • n=93 Participants
|
23.2 Years
STANDARD_DEVIATION 4.3 • n=4 Participants
|
24.4 Years
STANDARD_DEVIATION 5.31 • n=27 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=93 Participants
|
19 participants
n=4 Participants
|
50 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 4 month follow upPopulation: Participants in the HCEM (intervention) condition reported on their satisfaction with the computer software and specific HCEM intervention components.
CIAS Satisfaction Measure (adapted from Ondersma et al., 2005). Self-report instrument assessing the extent to which participants found the software acceptable. Mean ratings on items including Likeability and Ease of use; scores range from 1 (low) to 5 (high) in satisfaction. HCEM Satisfaction Measure. Self-report instrument assessing the extent to which participants found specific components of the HCEM intervention acceptable (e.g., videos, resources, information); scores range from 1 (low) to 7 (high) in satisfaction.
Outcome measures
| Measure |
Health Check-Up of Expectant Moms
n=31 Participants
Participants receive computer delivered intervention (Health Check-up for Expectant Moms)
Health Check-Up for Expectant Moms: Participants randomly assigned to the treatment condition will receive a 60-minute brief intervention on the Tablet PC after the baseline assessment. The software will personalize the intervention content based on the current risk status of each participant and will include a plan addressing endorsed risks. Within one month of baseline, there will be a 15-20 minute, computer-delivered booster session reviewing the personalized plan and identifying barriers in the reduction or risks and/or meeting the goals in the plan.
|
Time and Attention Matched Control Group
Participants will be presented a brief series of videos of television shows, with subsequent ratings of subjective preference
|
|---|---|---|
|
CIAS (Computerized Intervention Authoring Software) Satisfaction Measure Scores to Assess the Feasibility and Acceptability of the Computer and HCEM Software
CIAS measure
|
4.8 units on a scale
Interval 4.6 to 5.0
|
—
|
|
CIAS (Computerized Intervention Authoring Software) Satisfaction Measure Scores to Assess the Feasibility and Acceptability of the Computer and HCEM Software
HCEM measure
|
6.6 units on a scale
Interval 6.3 to 6.8
|
—
|
SECONDARY outcome
Timeframe: 4 month follow upParticipants completed the Timeline Followback interview and self-reported their daily sex risk behavior including condomless sex
Outcome measures
| Measure |
Health Check-Up of Expectant Moms
n=31 Participants
Participants receive computer delivered intervention (Health Check-up for Expectant Moms)
Health Check-Up for Expectant Moms: Participants randomly assigned to the treatment condition will receive a 60-minute brief intervention on the Tablet PC after the baseline assessment. The software will personalize the intervention content based on the current risk status of each participant and will include a plan addressing endorsed risks. Within one month of baseline, there will be a 15-20 minute, computer-delivered booster session reviewing the personalized plan and identifying barriers in the reduction or risks and/or meeting the goals in the plan.
|
Time and Attention Matched Control Group
n=19 Participants
Participants will be presented a brief series of videos of television shows, with subsequent ratings of subjective preference
|
|---|---|---|
|
Percentage of Participants With Reduced HIV/STI Risk Behavior (Condomless Sex) From Baseline to Follow-Up.
|
27 percentage of participants
|
5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 4-Month Follow-UpPopulation: The clustering within subject was accounted for using a generalized estimating equations (GEE) approach.
The Timeline Followback approach was used to collect self-reported data regarding alcohol and/or drug use over a 4-month time period.
Outcome measures
| Measure |
Health Check-Up of Expectant Moms
n=31 Participants
Participants receive computer delivered intervention (Health Check-up for Expectant Moms)
Health Check-Up for Expectant Moms: Participants randomly assigned to the treatment condition will receive a 60-minute brief intervention on the Tablet PC after the baseline assessment. The software will personalize the intervention content based on the current risk status of each participant and will include a plan addressing endorsed risks. Within one month of baseline, there will be a 15-20 minute, computer-delivered booster session reviewing the personalized plan and identifying barriers in the reduction or risks and/or meeting the goals in the plan.
|
Time and Attention Matched Control Group
n=19 Participants
Participants will be presented a brief series of videos of television shows, with subsequent ratings of subjective preference
|
|---|---|---|
|
Percentage of Participants Endorsing Alcohol/Drug Use at Baseline and 4-Month Follow-Up
Baseline assessment
|
77 percentage of participants
|
58 percentage of participants
|
|
Percentage of Participants Endorsing Alcohol/Drug Use at Baseline and 4-Month Follow-Up
Follow-up assessment
|
23 percentage of participants
|
42 percentage of participants
|
Adverse Events
Health Check-Up of Expectant Moms
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Time and Attention Matched Control Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Health Check-Up of Expectant Moms
n=31 participants at risk
Participants receive computer delivered intervention (Health Check-up for Expectant Moms)
Health Check-Up for Expectant Moms: Participants randomly assigned to the treatment condition will receive a 60-minute brief intervention on the Tablet PC after the baseline assessment. The software will personalize the intervention content based on the current risk status of each participant and will include a plan addressing endorsed risks. Within one month of baseline, there will be a 15-20 minute, computer-delivered booster session reviewing the personalized plan and identifying barriers in the reduction or risks and/or meeting the goals in the plan.
|
Time and Attention Matched Control Group
n=19 participants at risk
Participants will be presented a brief series of videos of television shows, with subsequent ratings of subjective preference
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Hospitalization
|
12.9%
4/31 • Number of events 4
|
5.3%
1/19 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Partner violence
|
3.2%
1/31 • Number of events 1
|
0.00%
0/19
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place