AzTrials
AzTrials

Malnutrition in PregnancyCOGENTNCT05949190

Improving Cognition and Gestational Duration With Targeted Nutrition

A study testing M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline), M-RUSF (Maternal Ready-to-Use Supplementary Food) and Azithromycin in people with Malnutrition in Pregnancy and Preterm Birth, run by Washington University School of Medicine at 10 sites in Sierra Leone.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 13 years and older
What is being tested?
M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline), M-RUSF (Maternal Ready-to-Use Supplementary Food) and Azithromycin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,660 participants
Where
10 sitesSierra Leone
Study dates
18 Aug 2023to Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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:
  • 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
  • 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
  • ≥ 13 years of age
  • Pregnant
  • Mid-upper arm circumference ≤ 23 cm or body-mass index < 18.5
Show all 10Show fewer
  • 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:
  • 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
  • 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
  • Patient Health Questionnaire-9 score ≥ 9

Who cannot join

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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Sierra Leone10 sites

  • Bandajuma

    Bandajuma, Southern Province

  • Bendu Malen

    Bendu, Southern Province

  • Blama Massaquoi

    Blama Massaquoi, Southern Province

  • Futa Peje

    Futa Peje, Southern Province

  • Gbondapi

    Gbondapi, Southern Province

  • Nyandehun Malen

    Nyandehun, Southern Province

  • Potoru

    Potoru, Southern Province

  • Pujehun Static

    Pujehun, Southern Province

  • Sahn Malen

    Sahn, Southern Province

  • Zimmi

    Zimmi, Southern Province

Other trials in Sierra Leone

About this study

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?
Read the detailed 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.

Being tested
M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline), M-RUSF (Maternal Ready-to-Use Supplementary Food), Azithromycin, Albendazole, Sulfadoxine pyrimethamine
Medical subject headings
Premature Birth, Depression, Postpartum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

  • M-RUSF (Maternal Ready-to-Use Supplementary Food)Dietary supplement

    Balanced energy protein supplement with added micronutrients

  • AzithromycinDrug

    1g dose

  • AlbendazoleDrug

    400mg dose

  • Sulfadoxine pyrimethamineDrug

    Monthly, 1,500/75mg dose

  • Cognitive behavioral therapyBehavioural

    Novel program developed for illiterate end-users

  • Insecticide-treated mosquito netOther

    Bed net to prevent malaria

Study groups in NCT05949190
Study groupRoleWhat they receive
M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline) and CBTExperimentalFactorial 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.
Receives: 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
M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline) and no CBTExperimentalFactorial 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.
Receives: 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
M-RUSF (Maternal Ready-to-use Supplementary Food without DHA/EPA/choline and CBTExperimentalFactorial 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.
Receives: 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
M-RUSF (Maternal Ready-to-use Supplementary Food without DHA/EPA/choline and no CBTExperimentalFactorial 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.
Receives: Dietary Supplement: M-RUSF (Maternal Ready-to-Use Supplementary Food); Drug: Azithromycin; Drug: Albendazole; Drug: Sulfadoxine pyrimethamine; Other: Insecticide-treated mosquito net

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Enrollment to birth (range 2 to 26 weeks)

  2. Malawi Developmental Assessment Tool (MDAT) global z-score

    Infant global age-adjusted z-score on MDAT

    Measured: 9 months post-birth

  3. 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)

    Measured: 8 weeks after diagnosis with ante- or post-partum depression

Secondary outcomes (23)

  1. Early preterm birth

    Birth < 34 weeks gestational age

    Measured: Enrollment to 34 weeks' gestation

  2. Birth weight

    Infant weight at birth

    Measured: Birth

  3. Birth length

    Infant length at birth

    Measured: Birth

  4. Low birth weight

    Birth weight < 2.5 kg

    Measured: Birth

  5. 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)

    Measured: 9 months after birth

  6. Preterm birth

    Birth < 37 weeks gestational age

    Measured: Enrollment to 37 weeks' gestation

  7. Neonatal mortality

    Infant death within the first 28 days of life

    Measured: Birth to 28 days of age

  8. Infant mortality

    Infant death

    Measured: Birth to end of follow-up (9 months)

  9. Depressive symptoms

    Adapted Patient Health Questionnaire-9 score (range 0-27, higher scores are worse)

    Measured: Through study completion, an average of 1.25 years

  10. Maternal and infant DHA status

    Maternal plasma, cord blood DHA status

    Measured: From Enrollment to delivery, an average of 15 weeks

  11. Maternal and infant choline status

    Blood choline concentration

    Measured: From Enrollment to delivery, an average of 15 weeks

  12. Maternal weight gain

    Average weekly weight gain

    Measured: From Enrollment to delivery, an average of 15 weeks

  13. Post-term delivery

    Delivery > 42 weeks' gestation

    Measured: From Enrollment to delivery, an average of 15 weeks

  14. Depression incidence

    Adapted PHQ-9 >= 9

    Measured: 8 weeks from time of depression diagnosis

  15. Birth chest circumference

    Infant chest circumference

    Measured: Birth

  16. Birth thigh circumference

    Infant thigh circumference

    Measured: Birth

  17. Birth head circumference

    Infant head circumference

    Measured: Birth

  18. Infant weight at 6 weeks, 3 months, 6 months, 9 months

    Infant weight

    Measured: Birth to 9 months

  19. Infant length at 6 weeks, 3 months, 6 months, 9 months

    Infant length

    Measured: Birth to 9 months

  20. Infant length-for-age z-score at 6 weeks, 3 months, 6 months, 9 months

    Infant length-for-age z-score

    Measured: Birth to 9 months

  21. 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.

    Measured: From Enrollment to birth, an average of 15 weeks

  22. Placental weight

    Weight of placenta in grams

    Measured: Birth

  23. Small for gestational age (SGA)

    Under 10th percentile in birth weight for gestational age

    Measured: Birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2023
  2. Study start18 Aug 2023
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
2x2 factorial design
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
1,660 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05949190
Sponsor's protocol ID
202305139
Acronym
COGENT
Status last verified
Feb 2026
First submitted
29 Jun 2023
Last updated
2 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected Individual; Patient Data (IPD).

Publications

  • 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.

    PubMed 42096203

Questions about this trial

What is this clinical trial studying?

A study testing M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline), M-RUSF (Maternal Ready-to-Use Supplementary Food) and Azithromycin in people with Malnutrition in Pregnancy and Preterm Birth, run by Washington University School of Medicine at 10 sites in Sierra Leone.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Sierra Leone. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gestational duration (time frame: Enrollment to birth (range 2 to 26 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05949190, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in