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Improving Cognition and Gestational Duration With Targeted Nutrition

NCT ID: NCT05949190

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-18

Study Completion Date

2026-10-31

Brief Summary

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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:

* 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?

Detailed Description

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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.

Conditions

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Malnutrition in Pregnancy Preterm Birth Child Development Postpartum Depression Antepartum Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

2x2 factorial design
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
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.

Study Groups

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

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.

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

Balanced energy protein supplement with added DHA/EPA/choline, micronutrients

Azithromycin

Intervention Type DRUG

1g dose

Albendazole

Intervention Type DRUG

400mg dose

Sulfadoxine pyrimethamine

Intervention Type DRUG

Monthly, 1,500/75mg dose

Cognitive behavioral therapy

Intervention Type BEHAVIORAL

Novel program developed for illiterate end-users

Insecticide-treated mosquito net

Intervention Type OTHER

Bed net to prevent malaria

M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline) and no CBT

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.

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

Balanced energy protein supplement with added DHA/EPA/choline, micronutrients

Azithromycin

Intervention Type DRUG

1g dose

Albendazole

Intervention Type DRUG

400mg dose

Sulfadoxine pyrimethamine

Intervention Type DRUG

Monthly, 1,500/75mg dose

Insecticide-treated mosquito net

Intervention Type OTHER

Bed net to prevent malaria

M-RUSF (Maternal Ready-to-use Supplementary Food without DHA/EPA/choline and CBT

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.

Group Type EXPERIMENTAL

M-RUSF (Maternal Ready-to-Use Supplementary Food)

Intervention Type DIETARY_SUPPLEMENT

Balanced energy protein supplement with added micronutrients

Azithromycin

Intervention Type DRUG

1g dose

Albendazole

Intervention Type DRUG

400mg dose

Sulfadoxine pyrimethamine

Intervention Type DRUG

Monthly, 1,500/75mg dose

Cognitive behavioral therapy

Intervention Type BEHAVIORAL

Novel program developed for illiterate end-users

Insecticide-treated mosquito net

Intervention Type OTHER

Bed net to prevent malaria

M-RUSF (Maternal Ready-to-use Supplementary Food without DHA/EPA/choline and no CBT

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.

Group Type EXPERIMENTAL

M-RUSF (Maternal Ready-to-Use Supplementary Food)

Intervention Type DIETARY_SUPPLEMENT

Balanced energy protein supplement with added micronutrients

Azithromycin

Intervention Type DRUG

1g dose

Albendazole

Intervention Type DRUG

400mg dose

Sulfadoxine pyrimethamine

Intervention Type DRUG

Monthly, 1,500/75mg dose

Insecticide-treated mosquito net

Intervention Type OTHER

Bed net to prevent malaria

Interventions

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

Balanced energy protein supplement with added DHA/EPA/choline, micronutrients

Intervention Type DIETARY_SUPPLEMENT

M-RUSF (Maternal Ready-to-Use Supplementary Food)

Balanced energy protein supplement with added micronutrients

Intervention Type DIETARY_SUPPLEMENT

Azithromycin

1g dose

Intervention Type DRUG

Albendazole

400mg dose

Intervention Type DRUG

Sulfadoxine pyrimethamine

Monthly, 1,500/75mg dose

Intervention Type DRUG

Cognitive behavioral therapy

Novel program developed for illiterate end-users

Intervention Type BEHAVIORAL

Insecticide-treated mosquito net

Bed net to prevent malaria

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Project Peanut Butter

OTHER

Sponsor Role collaborator

Open Philanthropy

OTHER

Sponsor Role collaborator

United States Department of Agriculture (USDA)

FED

Sponsor Role collaborator

Ministry of Health and Sanitation, Sierra Leone

OTHER_GOV

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark J Manary, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Bandajuma

Bandajuma, Southern Province, Sierra Leone

Site Status

Bendu Malen

Bendu, Southern Province, Sierra Leone

Site Status

Blama Massaquoi

Blama Massaquoi, Southern Province, Sierra Leone

Site Status

Futa Peje

Futa Peje, Southern Province, Sierra Leone

Site Status

Gbondapi

Gbondapi, Southern Province, Sierra Leone

Site Status

Nyandehun Malen

Nyandehun, Southern Province, Sierra Leone

Site Status

Potoru

Potoru, Southern Province, Sierra Leone

Site Status

Pujehun Static

Pujehun, Southern Province, Sierra Leone

Site Status

Sahn Malen

Sahn, Southern Province, Sierra Leone

Site Status

Zimmi

Zimmi, Southern Province, Sierra Leone

Site Status

Countries

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Sierra Leone

Other Identifiers

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202305139

Identifier Type: -

Identifier Source: org_study_id