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| Name | Class |
|---|---|
| Project Peanut Butter | OTHER |
| Open Philanthropy | OTHER |
| United States Department of Agriculture (USDA) | FED |
| Ministry of Health and Sanitation, Sierra Leone |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline) and CBT | Experimental | 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. |
|
| M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline) and no CBT | Experimental | 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. |
|
| M-RUSF (Maternal Ready-to-use Supplementary Food without DHA/EPA/choline and CBT |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline) | Dietary Supplement | Balanced energy protein supplement with added DHA/EPA/choline, micronutrients |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Enrollment to birth (range 2 to 26 weeks) |
| Malawi Developmental Assessment Tool (MDAT) global z-score | Infant global age-adjusted z-score on MDAT | 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) | 8 weeks after diagnosis with ante- or post-partum depression |
| Measure | Description | Time Frame |
|---|---|---|
| Early preterm birth | Birth < 34 weeks gestational age | Enrollment to 34 weeks' gestation |
| Birth weight | Infant weight at birth | Birth |
| Measure | Description | Time Frame |
|---|---|---|
| Intrauterine growth parameters | Estimated weight, head circumference, femur length, placental size | Subset of participants (enrollment GA <= 24 weeks) to undergo q4-6week serial ultrasounds |
| Gestational duration by baseline DHA status |
Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Mark J Manary, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bandajuma | Bandajuma | Southern Province | Sierra Leone | |||
| Bendu Malen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42096203 | Derived | Kleban E, Lee A, Koroma A, Hendrixson DT, Duncan J, Manary MJ, Stephenson KB. Cognitive Behavioral Therapy for Individuals With Low Literacy and Perinatal Depression: A Randomized Clinical Trial. JAMA Netw Open. 2026 May 1;9(5):e2611101. doi: 10.1001/jamanetworkopen.2026.11101. |
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All collected Individual; Patient Data (IPD).
Within 12 months of primary publication
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| OTHER_GOV |
2x2 factorial design
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In the food comparison, while the 2 study foods taste similar, full masking cannot be guaranteed. In the CBT comparison, participants and therapists will not be masked. In all cases, outcomes assessors will be masked.
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. |
|
| M-RUSF (Maternal Ready-to-use Supplementary Food without DHA/EPA/choline and no CBT | Experimental | 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. |
|
| M-RUSF (Maternal Ready-to-Use Supplementary Food) | Dietary Supplement | Balanced energy protein supplement with added micronutrients |
|
| Azithromycin | Drug | 1g dose |
|
| Albendazole | Drug | 400mg dose |
|
| Sulfadoxine pyrimethamine | Drug | Monthly, 1,500/75mg dose |
|
| Cognitive behavioral therapy | Behavioral | Novel program developed for illiterate end-users |
|
| Insecticide-treated mosquito net | Other | Bed net to prevent malaria |
|
| Birth length | Infant length at birth | Birth |
| Low birth weight | Birth weight < 2.5 kg | 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) | 9 months after birth |
| Preterm birth | Birth < 37 weeks gestational age | Enrollment to 37 weeks' gestation |
| Neonatal mortality | Infant death within the first 28 days of life | Birth to 28 days of age |
| Infant mortality | Infant death | Birth to end of follow-up (9 months) |
| Depressive symptoms | Adapted Patient Health Questionnaire-9 score (range 0-27, higher scores are worse) | Through study completion, an average of 1.25 years |
| Maternal and infant DHA status | Maternal plasma, cord blood DHA status | From Enrollment to delivery, an average of 15 weeks |
| Maternal and infant choline status | Blood choline concentration | From Enrollment to delivery, an average of 15 weeks |
| Maternal weight gain | Average weekly weight gain | From Enrollment to delivery, an average of 15 weeks |
| Post-term delivery | Delivery > 42 weeks' gestation | From Enrollment to delivery, an average of 15 weeks |
| Depression incidence | Adapted PHQ-9 >= 9 | 8 weeks from time of depression diagnosis |
| Birth chest circumference | Infant chest circumference | Birth |
| Birth thigh circumference | Infant thigh circumference | Birth |
| Birth head circumference | Infant head circumference | Birth |
| Infant weight at 6 weeks, 3 months, 6 months, 9 months | Infant weight | Birth to 9 months |
| Infant length at 6 weeks, 3 months, 6 months, 9 months | Infant length | 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 | 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. | From Enrollment to birth, an average of 15 weeks |
| Placental weight | Weight of placenta in grams | Birth |
| Small for gestational age (SGA) | Under 10th percentile in birth weight for gestational age | Birth |
Gestational duration modeled by enrollment DHA % of plasma fatty acids
| From enrollment to birth, an average of 15 weeks |
| Gestational duration by baseline maternal MUAC | Gestational duration modeled by enrollment MUAC | From enrollment to birth, an average of 15 weeks |
| Gestational duration by enrollment gestational age | Gestational duration modeled by enrollment GA | From enrollment to birth, an average of 15 weeks |
| Gestational duration by enrollment maternal age | Gestational duration modeled by enrollment maternal age | From enrollment to birth, an average of 15 weeks |
| Gestational duration by maternal parity | Gestational duration compared across levels of maternal parity | From enrollment to birth, an average of 15 weeks |
| Bendu |
| Southern Province |
| Sierra Leone |
| Blama Massaquoi | Blama Massaquoi | Southern Province | Sierra Leone |
| Futa Peje | Futa Peje | Southern Province | Sierra Leone |
| Gbondapi | Gbondapi | Southern Province | Sierra Leone |
| Nyandehun Malen | Nyandehun | Southern Province | Sierra Leone |
| Potoru | Potoru | Southern Province | Sierra Leone |
| Pujehun Static | Pujehun | Southern Province | Sierra Leone |
| Sahn Malen | Sahn | Southern Province | Sierra Leone |
| Zimmi | Zimmi | Southern Province | Sierra Leone |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011644 | Puerperal Disorders |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D015766 | Albendazole |
| C001205 | fanasil, pyrimethamine drug combination |
| D015928 | Cognitive Behavioral Therapy |
| D057148 | Insecticide-Treated Bednets |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D057147 | Mosquito Nets |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
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