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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05949190
Other study ID # 202305139
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 18, 2023
Est. completion date February 2026

Study information

Verified date March 2024
Source Washington University School of Medicine
Contact Mark J Manary, MD
Phone +1 314-454-2341
Email manarymj@wustl.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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?


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1600
Est. completion date February 2026
Est. primary completion date February 2026
Accepts healthy volunteers No
Gender All
Age group 13 Years and older
Eligibility 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: 1. 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 2. 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 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-RUSF study and meet the following criteria: 1. 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 2. 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 3. Patient Health Questionnaire-9 score = 9 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


Intervention

Dietary Supplement:
M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline)
Balanced energy protein supplement with added DHA/EPA/choline, micronutrients
M-RUSF (Maternal Ready-to-Use Supplementary Food)
Balanced energy protein supplement with added micronutrients
Drug:
Azithromycin
1g dose
Albendazole
400mg dose
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

Locations

Country Name City State
Sierra Leone Bandajuma Bandajuma Southern
Sierra Leone Bendu Malen Bendu Southern
Sierra Leone Blama Massaquoi Blama Massaquoi Southern
Sierra Leone Futa Peje Futa Peje Southern
Sierra Leone Gbondapi Gbondapi Southern
Sierra Leone Nyandehun Malen Nyandehun Southern
Sierra Leone Potoru Potoru Southern
Sierra Leone Pujehun Static Pujehun Southern
Sierra Leone Sahn Malen Sahn Southern
Sierra Leone Zimmi Zimmi Southern

Sponsors (5)

Lead Sponsor Collaborator
Washington University School of Medicine Ministry of Health and Sanitation, Sierra Leone, Open Philanthropy, Project Peanut Butter, United States Department of Agriculture (USDA)

Country where clinical trial is conducted

Sierra Leone, 

Outcome

Type Measure Description Time frame Safety issue
Other Intrauterine growth parameters Estimated weight, head circumference, femur length, placental size Subset of participants (enrollment GA <= 24 weeks) to undergo q4-6week serial ultrasounds
Other Gestational duration by baseline DHA status Gestational duration modeled by enrollment DHA % of plasma fatty acids From enrollment to birth, an average of 15 weeks
Other Gestational duration by baseline maternal MUAC Gestational duration modeled by enrollment MUAC From enrollment to birth, an average of 15 weeks
Other Gestational duration by enrollment gestational age Gestational duration modeled by enrollment GA From enrollment to birth, an average of 15 weeks
Other Gestational duration by enrollment maternal age Gestational duration modeled by enrollment maternal age From enrollment to birth, an average of 15 weeks
Other Gestational duration by maternal parity Gestational duration compared across levels of maternal parity From enrollment to birth, an average of 15 weeks
Primary 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)
Primary Malawi Developmental Assessment Tool (MDAT) global z-score Infant global age-adjusted z-score on MDAT 9 months post-birth
Primary 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
Secondary Early preterm birth Birth < 34 weeks gestational age Enrollment to 34 weeks' gestation
Secondary Birth weight Infant weight at birth Birth
Secondary Birth length Infant length at birth Birth
Secondary Low birth weight Birth weight < 2.5 kg Birth
Secondary 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
Secondary Preterm birth Birth < 37 weeks gestational age Enrollment to 37 weeks' gestation
Secondary Neonatal mortality Infant death within the first 28 days of life Birth to 28 days of age
Secondary Infant mortality Infant death Birth to end of follow-up (9 months)
Secondary Depressive symptoms Adapted Patient Health Questionnaire-9 score (range 0-27, higher scores are worse) Through study completion, an average of 1.25 years
Secondary Maternal and infant DHA status Maternal plasma, cord blood DHA status From Enrollment to delivery, an average of 15 weeks
Secondary Maternal and infant choline status Blood choline concentration From Enrollment to delivery, an average of 15 weeks
Secondary Maternal weight gain Average weekly weight gain From Enrollment to delivery, an average of 15 weeks
Secondary Post-term delivery Delivery > 42 weeks' gestation From Enrollment to delivery, an average of 15 weeks
Secondary Depression incidence Adapted PHQ-9 >= 9 8 weeks from time of depression diagnosis
Secondary Birth chest circumference Infant chest circumference Birth
Secondary Birth thigh circumference Infant thigh circumference Birth
Secondary Birth head circumference Infant head circumference Birth
Secondary Infant weight at 6 weeks, 3 months, 6 months, 9 months Infant weight Birth to 9 months
Secondary Infant length at 6 weeks, 3 months, 6 months, 9 months Infant length Birth to 9 months
Secondary 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
Secondary 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
Secondary Placental weight Weight of placenta in grams Birth
Secondary Small for gestational age (SGA) Under 10th percentile in birth weight for gestational age Birth
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