NCT05949190

Improving Cognition and Gestational Duration With Targeted Nutrition

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,660 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

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?

Detailed 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.

Conditions

• Malnutrition in Pregnancy
• Preterm Birth
• Child Development
• Postpartum Depression
• Antepartum Depression

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline)	Balanced energy protein supplement with added DHA/EPA/choline, micronutrients
DIETARY_SUPPLEMENT	M-RUSF (Maternal Ready-to-Use Supplementary Food)	Balanced energy protein supplement with added micronutrients
DRUG	Azithromycin	1g dose
DRUG	Albendazole	400mg dose
DRUG	Sulfadoxine pyrimethamine	Monthly, 1,500/75mg dose
BEHAVIORAL	Cognitive behavioral therapy	Novel program developed for illiterate end-users
OTHER	Insecticide-treated mosquito net	Bed net to prevent malaria

Timeline

• Start date: 2023-08-18
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2023-07-17
• Last updated: 2026-03-02

Locations

10 sites across 1 country: Sierra Leone