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Reducing Preterm Births in Underserved Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01344616
Recruitment Status : Completed
First Posted : April 29, 2011
Results First Posted : November 24, 2014
Last Update Posted : November 24, 2014
Sponsor:
Information provided by (Responsible Party):
James G. Christian, PHCC LP

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Preterm Birth
Low Birth Weight <2500 Grams
Verylow Birthweight <1500 Grams
Intervention Behavioral: lifestyle support
Enrollment 482
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Usual Clinical Care Lifestyle Counseling
Hide Arm/Group Description usual clinical care with no intervention

computer-based clinical support to patient

lifestyle support: computer-based lifestyle improvement support and clinician support

Period Title: Overall Study
Started 244 238
Completed 209 194
Not Completed 35 44
Arm/Group Title Usual Clinical Care Lifestyle Counseling Total
Hide Arm/Group Description usual clinical care with no intervention

computer-based clinical support to patient

lifestyle support: computer-based lifestyle improvement support and clinician support

Total of all reporting groups
Overall Number of Baseline Participants 244 238 482
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 244 participants 238 participants 482 participants
24.41  (5.26) 24.36  (5.18) 24.4  (5.21)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Female Number Analyzed 244 participants 238 participants 482 participants
244 238 482
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 244 participants 238 participants 482 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
244
 100.0%
238
 100.0%
482
 100.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 244 participants 238 participants 482 participants
244 238 482
1.Primary Outcome
Title Birthweight
Hide Description Birth weight < 2500 grams
Time Frame 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
One Set of twins in the lifestyle counseling arm and 4 sets of twins in the usual clinical care arm
Arm/Group Title Usual Clinical Care Lifestyle Counseling
Hide Arm/Group Description:
usual clinical care with no intervention

computer-based clinical support to patient

lifestyle support: computer-based lifestyle improvement support and clinician support

Overall Number of Participants Analyzed 213 195
Measure Type: Number
Unit of Measure: participants
40 26
2.Secondary Outcome
Title Gestational Weight
Hide Description [Not Specified]
Time Frame 9 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Usual Clinical Care Lifestyle Counseling
Hide Arm/Group Description usual clinical care with no intervention

computer-based clinical support to patient

lifestyle support: computer-based lifestyle improvement support and clinician support

All-Cause Mortality
Usual Clinical Care Lifestyle Counseling
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Usual Clinical Care Lifestyle Counseling
Affected / at Risk (%) Affected / at Risk (%)
Total   0/244 (0.00%)   0/233 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Usual Clinical Care Lifestyle Counseling
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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
Layout table for Results Point of Contact information
Name/Title: James G. Christian
Organization: PHCC LP
Phone: 7195468633
EMail: jim@phcclp.com
Layout table for additonal information
Responsible Party: James G. Christian, PHCC LP
ClinicalTrials.gov Identifier: NCT01344616    
Other Study ID Numbers: 2R44HD047031-02A2 ( U.S. NIH Grant/Contract )
First Submitted: July 27, 2010
First Posted: April 29, 2011
Results First Submitted: November 10, 2014
Results First Posted: November 24, 2014
Last Update Posted: November 24, 2014