Child Development, Pregnancy
Conditions
Keywords
Omega-3, Fatty acid, docosahexaenoic, Pregnant, neurodevelopment, stress, urban, african-american, supplement, nutrition, mental health
Brief summary
The purpose of the study is to test whether nutritional supplementation during pregnancy is associated with 1) improved maternal health during pregnancy; 2) improved infant birth and neurodevelopmental outcomes, and 3) whether the association between nutritional supplementation during pregnancy and infant outcomes is partially mediated by reductions in maternal perceived stress and stress reactivity during pregnancy.
Detailed description
Low-income pregnant women often experience chronic stress and consequently higher levels of stress hormones. In utero exposure to high levels of stress hormones can negatively affect the developing fetus and the infant's capacity for emotion and behavioral regulation. This program of research is designed to reduce the negative impact of prenatal stress on infant health and development via nutritional supplementation of docosahexaenoic acid (DHA) during pregnancy. DHA is a long-chain polyunsaturated fatty acid member of the omega-3 fatty acid family. DHA is found in its highest concentrations in neural cell membranes, affecting receptor function, neurotransmitter uptake, and signal transmission. There is growing evidence that low levels of dietary DHA intake are associated with suboptimal response to stress and that DHA supplementation can modulate stress response. One hundred sixty-two pregnant women will be randomly assigned to receive 450 mg/daily of DHA or placebo beginning at 9-12 weeks of gestation through the end of pregnancy. Perceived stress, stressful life events, anxiety, and depression, inflammatory markers, DHA levels and response to a laboratory stressor will be assessed at baseline and at 24, 30, and 36 weeks of pregnancy. Neonatal outcomes (e.g., gestational age, birth weight, delivery complications) will be collected from medical records, and infant neurodevelopmental outcomes and stress reactivity will be assessed at 1, 4 and 9 months of age. Coded data will be analyzed by the Investigators at University of Chicago and University of Pittsburgh
Interventions
DIETARY_SUPPLEMENTDHA
2 dietary supplement gel capsules providing 450 mg of DHA twice daily by oral intake for 24 weeks
DIETARY_SUPPLEMENTSugar pill
2 dietary supplement gel capsules providing 450 mg of soybean oil twice daily by oral intake for 24 weeks
Sponsors
University of Chicago
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 34 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 18 and 34 * Household recipient of public assistance (e.g. Medicaid insurance) due to low income * Low levels of DHA consumption as defined as less than two fish servings per week
Exclusion criteria
* Reports of known medial complications * Regular use of steroid medications, alcohol, cigarettes, or illegal substances (by maternal report) * Use of blood thinners or anti-coagulants * Use of psychotropic medications * Allergy to iodine and/or soy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Change in Perceived Stress Scale (PSS) Score From Visit 1 to Visit 4 | 16 months | Will be assessed at baseline and at 24, 30, and 36 weeks of pregnancy, and at 1, 4 and 9 months after giving birth. The Perceived Stress Scale score is obtained by summing the points awarded to the 10 items and it ranges from 0 to 40 where: 0-13 - Low stress 14-26 - Moderate stress 27-40 - High perceived stress |
| Average Change in Perceived Stress Scale (PSS) Score From Visit 1 to Visit 3 | 12 months | Will be assessed at baseline and at 24, 30, and 36 weeks of pregnancy, and at 1, 4 and 9 months after giving birth. The Perceived Stress Scale score is obtained by summing the points awarded to the 10 items and it ranges from 0 to 40 where: 0-13 - Low stress 14-26 - Moderate stress 27-40 - High perceived stress |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKathryn Keenan, Ph.D
University of Chicago
Participant flow
Recruitment details
Active recruitment from the University of Chicago Medical Center and affiliated Federally Qualified Health Centers (FQHC) occurred between 2016 and 2021.
Participants by arm
| Arm | Count |
|---|---|
| Oral Supplement for Pregnant Women 450 mg/daily of DHA beginning at 10-16 weeks of gestation through the end of pregnancy
DHA: 2 dietary supplement gel capsules providing 450 mg of DHA twice daily by oral intake for 24 weeks | 112 |
| Sugar Pill 450 mg/daily of sugar pill beginning at 10-16 weeks of gestation through the end of pregnancy
Sugar pill: 2 dietary supplement gel capsules providing 450 mg of soybean oil twice daily by oral intake for 24 weeks | 56 |
| Total | 168 |
Baseline characteristics
| Characteristic | Oral Supplement for Pregnant Women | Sugar Pill | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 112 Participants | 56 Participants | 168 Participants |
| Age, Continuous | 25.80 years STANDARD_DEVIATION 4.27 | 25.47 years STANDARD_DEVIATION 4.11 | 25.69 years STANDARD_DEVIATION 4.21 |
| Perceived Stress Scale Total Score at Baseline | 14.87 Perceived Stress Scale Total Score STANDARD_DEVIATION 7.47 | 17.58 Perceived Stress Scale Total Score STANDARD_DEVIATION 8.16 | 15.77 Perceived Stress Scale Total Score STANDARD_DEVIATION 7.79 |
| 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 | 112 Participants | 56 Participants | 168 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 | 112 participants | 56 participants | 168 participants |
| Sex: Female, Male Female | 112 Participants | 56 Participants | 168 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 112 | 0 / 56 |
| other Total, other adverse events | 2 / 112 | 0 / 56 |
| serious Total, serious adverse events | 7 / 112 | 2 / 56 |
Outcome results
Primary
Average Change in Perceived Stress Scale (PSS) Score From Visit 1 to Visit 3
Will be assessed at baseline and at 24, 30, and 36 weeks of pregnancy, and at 1, 4 and 9 months after giving birth. The Perceived Stress Scale score is obtained by summing the points awarded to the 10 items and it ranges from 0 to 40 where: 0-13 - Low stress 14-26 - Moderate stress 27-40 - High perceived stress
Time frame: 12 months
Population: Of the 168 participants recruited, 133 had PSS data for visits 1, 2 and 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Supplement for Pregnant Women | Average Change in Perceived Stress Scale (PSS) Score From Visit 1 to Visit 3 | 1.91 change in score on a scale | Standard Deviation 6.09 |
| Sugar Pill | Average Change in Perceived Stress Scale (PSS) Score From Visit 1 to Visit 3 | 3.56 change in score on a scale | Standard Deviation 7.49 |
Primary
Average Change in Perceived Stress Scale (PSS) Score From Visit 1 to Visit 4
Will be assessed at baseline and at 24, 30, and 36 weeks of pregnancy, and at 1, 4 and 9 months after giving birth. The Perceived Stress Scale score is obtained by summing the points awarded to the 10 items and it ranges from 0 to 40 where: 0-13 - Low stress 14-26 - Moderate stress 27-40 - High perceived stress
Time frame: 16 months
Population: Of the 168 participants recruited, 127 had PSS data for all 4 visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Supplement for Pregnant Women | Average Change in Perceived Stress Scale (PSS) Score From Visit 1 to Visit 4 | 2.33 change in score on a scale | Standard Deviation 6.81 |
| Sugar Pill | Average Change in Perceived Stress Scale (PSS) Score From Visit 1 to Visit 4 | 3.65 change in score on a scale | Standard Deviation 6.66 |