Trial Outcomes & Findings for Reducing Preterm Births in Underserved Pregnant Women (NCT NCT01344616)

NCT ID: NCT01344616

Last Updated: 2014-11-24

Results Overview

Birth weight \< 2500 grams

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 482 participants
• Primary outcome timeframe: 9 months
• Results posted on: 2014-11-24

Participant Flow

Participant milestones

Measure	Usual Clinical Care usual clinical care with no intervention	Lifestyle Counseling computer-based clinical support to patient lifestyle support: computer-based lifestyle improvement support and clinician support
Overall Study STARTED	244	238
Overall Study COMPLETED	209	194
Overall Study NOT COMPLETED	35	44

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reducing Preterm Births in Underserved Pregnant Women

Baseline characteristics by cohort

Measure	Usual Clinical Care n=244 Participants usual clinical care with no intervention	Lifestyle Counseling n=238 Participants computer-based clinical support to patient lifestyle support: computer-based lifestyle improvement support and clinician support	Total n=482 Participants Total of all reporting groups
Age, Continuous	24.41 Years STANDARD_DEVIATION 5.26 • n=5 Participants	24.36 Years STANDARD_DEVIATION 5.18 • n=7 Participants	24.4 Years STANDARD_DEVIATION 5.21 • n=5 Participants
Sex/Gender, Customized Female	244 participants n=5 Participants	238 participants n=7 Participants	482 participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	244 Participants n=5 Participants	238 Participants n=7 Participants	482 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	244 participants n=5 Participants	238 participants n=7 Participants	482 participants n=5 Participants

PRIMARY outcome

Timeframe: 9 months

Population: One Set of twins in the lifestyle counseling arm and 4 sets of twins in the usual clinical care arm

Birth weight < 2500 grams

Outcome measures

Measure	Usual Clinical Care n=213 Participants usual clinical care with no intervention	Lifestyle Counseling n=195 Participants computer-based clinical support to patient lifestyle support: computer-based lifestyle improvement support and clinician support
Birthweight	40 participants	26 participants

SECONDARY outcome

Timeframe: 9 months

Outcome measures

Outcome data not reported

Adverse Events

Usual Clinical Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lifestyle Counseling

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

James G. Christian

PHCC LP

Phone: 7195468633

Email: jim@phcclp.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place