Low Birth Weight <2500 Grams, Preterm Birth, Verylow Birthweight <1500 Grams
Conditions
Keywords
computer-based behavioral support
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.
Detailed description
The primary aim of this proposal is to test the efficacy of a clinic-based, computer-assisted intervention system to significantly reduce preterm births in high-risk populations. This system will: (1) assess a pregnant woman's unique risks in six modifiable areas associated with increased risks of preterm birth including smoking cessation, poor nutrition, domestic violence, maternal depression and stress, urinary and reproductive tract infections and substance use; (2) provide her with tailored advice and action planning tools on reducing her risks; (3) provide her certified nurse midwife or physician with information related to her assessed risks and counseling suggestions tailored for her needs, and \[(4) promote effective referrals to, and successful linkages with community-based support organizations.\] Because preterm birth rates are much higher for underserved African American women, we are proposing to focus the intervention with this population.
Interventions
BEHAVIORALlifestyle support
computer-based lifestyle improvement support and clinician support
Sponsors
PHCC LP
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 48 Years
Healthy volunteers
Yes
Inclusion criteria
Study inclusion criteria include: 1. age 16-48 years, 2. 1st trimester of pregnancy, 3. race/ethnicity (non-Hispanic Black, or English-speaking Hispanic Black), and 4) a self-reported completion of grade 6 or higher.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Birthweight | 9 months | Birth weight \< 2500 grams |
Secondary
| Measure | Time frame |
|---|---|
| Gestational Weight | 9 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Clinical Care usual clinical care with no intervention | 244 |
| Lifestyle Counseling computer-based clinical support to patient
lifestyle support: computer-based lifestyle improvement support and clinician support | 238 |
| Total | 482 |
Baseline characteristics
| Characteristic | Usual Clinical Care | Lifestyle Counseling | Total |
|---|---|---|---|
| Age, Continuous | 24.41 Years STANDARD_DEVIATION 5.26 | 24.36 Years STANDARD_DEVIATION 5.18 | 24.4 Years STANDARD_DEVIATION 5.21 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 244 Participants | 238 Participants | 482 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 244 participants | 238 participants | 482 participants |
| Sex/Gender, Customized Female | 244 participants | 238 participants | 482 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 244 | 0 / 233 |
Outcome results
Primary
Birthweight
Birth weight \< 2500 grams
Time frame: 9 months
Population: One Set of twins in the lifestyle counseling arm and 4 sets of twins in the usual clinical care arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Clinical Care | Birthweight | 40 participants |
| Lifestyle Counseling | Birthweight | 26 participants |
Secondary
Gestational Weight
Time frame: 9 months