Improving Cognition and Gestational Duration With Targeted Nutrition (COGENT)
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Details and patient eligibility
About
The goal of this clinical trial is to test (1) a novel maternal ready-to-use supplementary food and (2) a novel cognitive behavioral therapy intervention in undernourished Sierra Leonean women. The main questions it aims to answer are:
- Will the addition of omega-3 long-chain polyunsaturated fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), as well as choline, to a maternal ready-to-use supplementary food (M-RUSF+) prolong gestation when compared with a similar supplementary food except that it lacks DHA, EPA, and choline (M-RUSF)?
- Will M-RUSF+ improve infant cognitive development at 9 months of age when compared with M-RUSF?
- Will the novel CBT program improve ante- and post-partum depression?
Full description
Undernutrition in pregnancy is common, affecting nearly 10% of women worldwide and 25% of women in Sub-Saharan Africa, and increases risks for both mothers and their offspring, including bleeding, preterm birth, neonatal mortality, and impaired infant cognitive development. Available treatments have limited impact on these outcomes, which affect millions annually. A recent trial in Sierra Leone showed that pairing high-quality supplementary nutrition with anti-infective measures led to greater maternal weight gain, longer and heavier newborns, and reduced neonatal mortality. In addition, ante- and postpartum depression are underrecognized and undertreated in rural Sub-Saharan Africa.
The goal of this clinical trial is to test (1) a novel maternal ready-to-use supplementary food (M-RUSF+) and (2) a novel cognitive behavioral therapy (CBT) program developed for illiterate users, in undernourished pregnant women in Sierra Leone. The main questions it aims to answer are:
- Will the addition of omega-3 long-chain polyunsaturated fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), as well as choline, to a maternal ready-to-use supplementary food (M-RUSF+) prolong gestation when compared with a similar supplementary food except that it lacks DHA, EPA, and choline (M-RUSF)?
- Will M-RUSF+ improve infant cognitive development at 9 months of age when compared with M-RUSF?
- Will the novel CBT program improve ante- and post-partum depression?
Participants will present to government-run antenatal clinics for screening. If they quality for enrollment and consent to participate, they will undergo:
ANTENATALLY
- randomization to intervention vs. control group
- bi-weekly anthropometric measurements
- ultrasound gestational age estimation
- demographic, socioeconomic, and health history questionnaires
- bi-weekly blood pressure measurement
- bi-weekly screening for ante- and post-partum depression
- two blood spot collections
POSTNATALLY
- birth measurements of mother and offspring
- cord blood and placental sampling for a subset
- 5 clinic visits for mother and offspring anthropometric measurements, health history, breastfeeding practice, maternal mental health questions
- offspring developmental assessments
All participants will receive:
ANTENATALLY
- 100g/day of M-RUSF+ or M-RUSF, containing 530 Kcal, 19g protein, United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) equivalent
- insecticide-treated bed nets
- a single dose of albendazole de-worming medicine
- monthly malaria chemoprophylaxis
- single doses of azithromycin in the second and third trimesters
- safe birth kits
If participants develop ante- or postpartum depression and are randomized to CBT, they will receive 6 sessions of CBT.
Enrollment
Sex
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Volunteers
Inclusion criteria
In order to be eligible to participate in the M-RUSF+ vs. M-RUSF element of the study, an individual must meet all of the following criteria:
- Provision of signed (or thumb-printed) and dated informed consent form 1a. Women who are ≥ 18 years of age or married will be allowed to consent for themselves 1b. Women who are < 18 years of age and unmarried must provide assent and a parent or guardian must provide consent
- Stated willingness to comply with all study procedures and availability for the duration of the study, including no plan to move from the catchment area of a participating clinic
- ≥ 13 years of age
- Pregnant
- Mid-upper arm circumference ≤ 23 cm or body-mass index < 18.5
In order to be eligible to participate in the CBT vs. no CBT element of the study (factorial design with the above), an individual must be enrolled in the M-RUSF+ vs. M-RUSF study and meet the following criteria:
- Provision of signed (or thumb-printed) and dated informed consent form 1a. Women who are ≥ 18 years of age or married will be allowed to consent for themselves 1b. Women who are < 18 years of age and unmarried must assent and a parent or guardian consent must provide consent
- Stated willingness to comply with all study procedures and availability for the duration of the study, including no plan to move from the catchment area of a participating clinic
- Patient Health Questionnaire-9 score ≥ 9
Exclusion criteria
- Participation in a concomitant supplementary feeding program
- Known allergy to components of intervention or control study food or medications
- Known gestational diabetes
- Hypertension
- Severe anemia, or other condition requiring immediate hospitalization
Trial design
Primary purpose
Allocation
Interventional model
Masking
1,600 participants in 4 patient groups
Trial contacts and locations
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Central trial contact
Mark J Manary, MD
Data sourced from clinicaltrials.gov
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