An interventional study of M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline) and M-RUSF (Maternal Ready-to-Use Supplementary Food) in Malnutrition in Pregnancy, Preterm Birth and Child Development, sponsored by Washington University School of Medicine. Active, not recruiting at 10 sites in Sierra Leone. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
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:
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:
Participants will present to government-run antenatal clinics for screening. If they quality for enrollment and consent to participate, they will undergo:
ANTENATALLY
POSTNATALLY
All participants will receive:
ANTENATALLY
If participants develop ante- or postpartum depression and are randomized to CBT, they will receive 6 sessions of CBT.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Factorial 1. A daily dose of 500mg DHA, 500mg EPA, and 550mg choline will be added to the maternal balanced energy-protein RUSF. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) for women. M-RUSF+ will be vacuum sealed and packaged in foil sachets containing 100g of food. Factorial 2. Among participants randomized to receive M-RUSF+ vs. M-RUSF, those who develop ante- or postpartum depression will receive 6 sessions of CBT adopted for use in illiterate populations will be provided.
Dietary Supplement: M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline) · Drug: Azithromycin · Drug: Albendazole · Drug: Sulfadoxine pyrimethamine · Behavioral: Cognitive behavioral therapy · Other: Insecticide-treated mosquito net
Factorial 1. A daily dose of 500mg DHA, 500mg EPA, and 550mg choline will be added to the maternal balanced energy-protein RUSF. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the UNICEF/World Health Organization/United Nations multiple micronutrient supplement for pregnant/lactating women. M-RUSF+ will be vacuum sealed and packaged in foil sachets containing 100g of food. Factorial 2. Participants who develop ante- or postpartum depression will not receive CBT.
Dietary Supplement: M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline) · Drug: Azithromycin · Drug: Albendazole · Drug: Sulfadoxine pyrimethamine · Other: Insecticide-treated mosquito net
Factorial 1. M-RUSF will be similar to M-RUSF+, except it will not contain added DHA or EPA, and will only contain 5mg of added choline to help with flavor masking. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the UNIMMAP for pregnant/lactating women. M-RUSF+ will be vacuum sealed and packaged in foil sachets containing 100g of food. Factorial 2. Participants who develop ante- or postpartum depression will receive 6 sessions of CBT adopted for use in illiterate populations will be provided.
Dietary Supplement: M-RUSF (Maternal Ready-to-Use Supplementary Food) · Drug: Azithromycin · Drug: Albendazole · Drug: Sulfadoxine pyrimethamine · Behavioral: Cognitive behavioral therapy · Other: Insecticide-treated mosquito net
Factorial 1. M-RUSF will be similar to M-RUSF+, except it will not contain added DHA or EPA, and will only contain 5mg of added choline to help with flavor masking. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the UNIMMAP for pregnant/lactating women. M-RUSF+ will be vacuum sealed and packaged in foil sachets containing 100g of food. Factorial 2. Participants who develop ante- or postpartum depression will not receive CBT.
Dietary Supplement: M-RUSF (Maternal Ready-to-Use Supplementary Food) · Drug: Azithromycin · Drug: Albendazole · Drug: Sulfadoxine pyrimethamine · Other: Insecticide-treated mosquito net
Balanced energy protein supplement with added DHA/EPA/choline, micronutrients
Balanced energy protein supplement with added micronutrients
1g dose
400mg dose
Monthly, 1,500/75mg dose
Novel program developed for illiterate end-users
Bed net to prevent malaria
Gestational duration
Enrollment ultrasound estimated gestational age plus time between enrollment and delivery. For the primary outcome, this will only be assessed among participants enrolled \<= 30 weeks gestational age and with singleton live births
Time frame: Enrollment to birth (range 2 to 26 weeks)
Malawi Developmental Assessment Tool (MDAT) global z-score
Infant global age-adjusted z-score on MDAT
Time frame: 9 months post-birth
Adapted Patient Health Questionnaire-9 (PHQ-9) score
Among participants who develop ante- or post-partum depression, adapted Patient Health Questionnaire-9 score, (range 0-27, higher scores are worse)
Time frame: 8 weeks after diagnosis with ante- or post-partum depression
Early preterm birth
Birth \< 34 weeks gestational age
Time frame: Enrollment to 34 weeks' gestation
Birth weight
Infant weight at birth
Time frame: Birth
Birth length
Infant length at birth
Time frame: Birth
Low birth weight
Birth weight \< 2.5 kg
Time frame: Birth
Malawi Developmental Assessment Test sub-domain z-scores
Gross motor, fine motor, language, and social domain z-scores (expected range -4 to 2, higher scores are better)
Time frame: 9 months after birth
Preterm birth
Birth \< 37 weeks gestational age
Time frame: Enrollment to 37 weeks' gestation
Neonatal mortality
Infant death within the first 28 days of life
Time frame: Birth to 28 days of age
Infant mortality
Infant death
Time frame: Birth to end of follow-up (9 months)
Depressive symptoms
Adapted Patient Health Questionnaire-9 score (range 0-27, higher scores are worse)
Time frame: Through study completion, an average of 1.25 years
Maternal and infant DHA status
Maternal plasma, cord blood DHA status
Time frame: From Enrollment to delivery, an average of 15 weeks
Maternal and infant choline status
Blood choline concentration
Time frame: From Enrollment to delivery, an average of 15 weeks
Maternal weight gain
Average weekly weight gain
Time frame: From Enrollment to delivery, an average of 15 weeks
Post-term delivery
Delivery \> 42 weeks' gestation
Time frame: From Enrollment to delivery, an average of 15 weeks
Depression incidence
Adapted PHQ-9 \>= 9
Time frame: 8 weeks from time of depression diagnosis
Birth chest circumference
Infant chest circumference
Time frame: Birth
Birth thigh circumference
Infant thigh circumference
Time frame: Birth
Birth head circumference
Infant head circumference
Time frame: Birth
Infant weight at 6 weeks, 3 months, 6 months, 9 months
Infant weight
Time frame: Birth to 9 months
Infant length at 6 weeks, 3 months, 6 months, 9 months
Infant length
Time frame: Birth to 9 months
Infant length-for-age z-score at 6 weeks, 3 months, 6 months, 9 months
Infant length-for-age z-score
Time frame: Birth to 9 months
Gestational duration
Enrollment ultrasound estimated gestational age plus time between enrollment and delivery. For this secondary outcome, all enrolled women will be included in analysis.
Time frame: From Enrollment to birth, an average of 15 weeks
Placental weight
Weight of placenta in grams
Time frame: Birth
Small for gestational age (SGA)
Under 10th percentile in birth weight for gestational age
Time frame: Birth
Intrauterine growth parameters
Estimated weight, head circumference, femur length, placental size
Time frame: Subset of participants (enrollment GA <= 24 weeks) to undergo q4-6week serial ultrasounds
Gestational duration by baseline DHA status
Gestational duration modeled by enrollment DHA % of plasma fatty acids
Time frame: From enrollment to birth, an average of 15 weeks
Gestational duration by baseline maternal MUAC
Gestational duration modeled by enrollment MUAC
Time frame: From enrollment to birth, an average of 15 weeks
Gestational duration by enrollment gestational age
Gestational duration modeled by enrollment GA
Time frame: From enrollment to birth, an average of 15 weeks
Gestational duration by enrollment maternal age
Gestational duration modeled by enrollment maternal age
Time frame: From enrollment to birth, an average of 15 weeks
Gestational duration by maternal parity
Gestational duration compared across levels of maternal parity
Time frame: From enrollment to birth, an average of 15 weeks
Plan to share: Yes — All collected Individual; Patient Data (IPD).
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Within 12 months of primary publication
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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