Improving Cognition and Gestational Duration With Targeted Nutrition

Last updated: March 11, 2024
Sponsor: Washington University School of Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diet And Nutrition

Depression

Weight Loss

Treatment

M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline)

Azithromycin

Albendazole

Clinical Study ID

NCT05949190
202305139
  • Ages > 13
  • All Genders

Study 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?

Eligibility Criteria

Inclusion

Inclusion Criteria: In order to be eligible to participate in the M-RUSF+ vs. M-RUSF element of the study, anindividual must meet all of the following criteria:

  1. Provision of signed (or thumb-printed) and dated informed consent form 1a. Women whoare ≥ 18 years of age or married will be allowed to consent for themselves 1b. Womenwho are < 18 years of age and unmarried must provide assent and a parent or guardianmust provide consent
  2. Stated willingness to comply with all study procedures and availability for theduration of the study, including no plan to move from the catchment area of aparticipating clinic
  3. ≥ 13 years of age
  4. Pregnant
  5. 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-RUSFstudy and meet the following criteria:
  6. Provision of signed (or thumb-printed) and dated informed consent form 1a. Women whoare ≥ 18 years of age or married will be allowed to consent for themselves 1b. Womenwho are < 18 years of age and unmarried must assent and a parent or guardian consentmust provide consent
  7. Stated willingness to comply with all study procedures and availability for theduration of the study, including no plan to move from the catchment area of aparticipating clinic
  8. Patient Health Questionnaire-9 score ≥ 9

Exclusion

Exclusion Criteria:

  1. Participation in a concomitant supplementary feeding program
  2. Known allergy to components of intervention or control study food or medications
  3. Known gestational diabetes
  4. Hypertension
  5. Severe anemia, or other condition requiring immediate hospitalization

Study Design

Total Participants: 1600
Treatment Group(s): 7
Primary Treatment: M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline)
Phase:
Study Start date:
August 18, 2023
Estimated Completion Date:
February 28, 2026

Study 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.

Connect with a study center

  • Bandajuma

    Bandajuma, Southern
    Sierra Leone

    Active - Recruiting

  • Bendu Malen

    Bendu, Southern
    Sierra Leone

    Active - Recruiting

  • Blama Massaquoi

    Blama Massaquoi, Southern
    Sierra Leone

    Active - Recruiting

  • Futa Peje

    Futa Peje, Southern
    Sierra Leone

    Active - Recruiting

  • Gbondapi

    Gbondapi, Southern
    Sierra Leone

    Active - Recruiting

  • Nyandehun Malen

    Nyandehun, Southern
    Sierra Leone

    Active - Recruiting

  • Potoru

    Potoru, Southern
    Sierra Leone

    Active - Recruiting

  • Pujehun Static

    Pujehun, Southern
    Sierra Leone

    Active - Recruiting

  • Sahn Malen

    Sahn, Southern
    Sierra Leone

    Active - Recruiting

  • Zimmi

    Zimmi, Southern
    Sierra Leone

    Active - Recruiting

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