NCT01344616

Brief Summary

Timely screening and management of modifiable conditions can reduce preterm births, yet providing effective prenatal risk management systems to meet the unique needs of medically underserved populations is complex. If the proposed system proves to be effective in reducing preterm births it can improve maternal and child quality of life as well as reduce the economic burden of preterm births in the U.S.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
482

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2010

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
9 months until next milestone

First Posted

Study publicly available on registry

April 29, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 24, 2014

Completed
Last Updated

November 24, 2014

Status Verified

November 1, 2014

Enrollment Period

2.9 years

First QC Date

July 27, 2010

Results QC Date

November 10, 2014

Last Update Submit

November 19, 2014

Conditions

Preterm BirthLow Birth Weight <2500 GramsVerylow Birthweight <1500 Grams

Keywords

computer-based behavioral support

Outcome Measures

Primary Outcomes (1)

  • Birthweight

    Birth weight \< 2500 grams

    9 months

Secondary Outcomes (1)

  • Gestational Weight

    9 months

Study Arms (2)

usual clinical care

NO INTERVENTION

usual clinical care with no intervention

lifestyle counseling

EXPERIMENTAL

computer-based clinical support to patient

Behavioral: lifestyle support

Interventions

lifestyle supportBEHAVIORAL

computer-based lifestyle improvement support and clinician support

lifestyle counseling

Eligibility Criteria

Age16 Years - 48 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age 16-48 years,
  • st trimester of pregnancy,
  • race/ethnicity (non-Hispanic Black, or English-speaking Hispanic Black), and 4) a self-reported completion of grade 6 or higher.

You may not qualify if:

  • a literacy level of \< grade 6. No prior experience using a computer is needed. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PHCC LP

Pueblo, Colorado, 81003, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Results Point of Contact

Title
James G. Christian
Organization
PHCC LP
jim@phcclp.com
7195468633

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

July 27, 2010

First Posted

April 29, 2011

Study Start

August 1, 2010

Primary Completion

July 1, 2013

Study Completion

October 1, 2013

Last Updated

November 24, 2014

Results First Posted

November 24, 2014

Record last verified: 2014-11

Locations

US(1)