Active — Not RecruitingNot Applicable

Improving Cognition and Gestational Duration With Targeted Nutrition

Sierra Leone1,660 participantsStarted 2023-08-18

Plain-language 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?

Who can participate

Age range13 Years

SexALL

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Inclusion 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
✓. 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

What they're measuring

Gestational duration

Timeframe: Enrollment to birth (range 2 to 26 weeks)

Malawi Developmental Assessment Tool (MDAT) global z-score

Timeframe: 9 months post-birth

Adapted Patient Health Questionnaire-9 (PHQ-9) score

Timeframe: 8 weeks after diagnosis with ante- or post-partum depression

Trial details

NCT IDNCT05949190

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10

View on ClinicalTrials.gov More Malnutrition in Pregnancy trials