Improving Cognition and Gestational Duration With Targeted Nutrition

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?

Conditions

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

Interventions

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

Sponsors & Collaborators

• Project Peanut Butter

  collaborator OTHER

• Open Philanthropy

  collaborator OTHER

• United States Department of Agriculture (USDA)

  collaborator FED

• Ministry of Health and Sanitation, Sierra Leone

  collaborator OTHER_GOV

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Mark J Manary, MD · Washington University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

13 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-18

Primary Completion

2026-10-31

Completion

2026-10-31

Countries

• Sierra Leone

Study Locations