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Improving Cognition and Gestational Duration With Targeted Nutrition (COGENT)

Primary Purpose

Malnutrition in Pregnancy, Preterm Birth, Child Development

Status
Recruiting
Phase
Not Applicable
Locations
Sierra Leone
Study Type
Interventional
Intervention
M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline)
M-RUSF (Maternal Ready-to-Use Supplementary Food)
Azithromycin
Albendazole
Sulfadoxine pyrimethamine
Cognitive behavioral therapy
Insecticide-treated mosquito net
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition in Pregnancy

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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 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 Exclusion Criteria: 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

Sites / Locations

  • BandajumaRecruiting
  • Bendu MalenRecruiting
  • Blama MassaquoiRecruiting
  • Futa PejeRecruiting
  • GbondapiRecruiting
  • Nyandehun MalenRecruiting
  • PotoruRecruiting
  • Pujehun StaticRecruiting
  • Sahn MalenRecruiting
  • ZimmiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

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

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

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

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

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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
Malawi Developmental Assessment Tool (MDAT) global z-score
Infant global age-adjusted z-score on MDAT
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)

Secondary Outcome Measures

Early preterm birth
Birth < 34 weeks gestational age
Birth weight
Infant weight at birth
Birth length
Infant length at birth
Low birth weight
Birth weight < 2.5 kg
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)
Preterm birth
Birth < 37 weeks gestational age
Neonatal mortality
Infant death within the first 28 days of life
Infant mortality
Infant death
Depressive symptoms
Adapted Patient Health Questionnaire-9 score (range 0-27, higher scores are worse)
Maternal and infant DHA status
Plasma, Red Blood Cell (RBC) membrane DHA status
Maternal and infant choline status
Blood choline concentration
Maternal weight gain
Average weekly weight gain
Post-term delivery
Delivery > 42 weeks' gestation
Depression incidence
Adapted PHQ-9 >= 9
Birth chest circumference
Infant chest circumference
Birth thigh circumference
Infant thigh circumference
Birth head circumference
Infant head circumference
Infant weight at 6 weeks, 3 months, 6 months, 9 months
Infant weight
Infant length at 6 weeks, 3 months, 6 months, 9 months
Infant length
Infant length-for-age z-score at 6 weeks, 3 months, 6 months, 9 months
Infant length-for-age z-score
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.

Full Information

First Posted
June 29, 2023
Last Updated
September 11, 2023
Sponsor
Washington University School of Medicine
Collaborators
Project Peanut Butter, Open Philanthropy, United States Department of Agriculture (USDA), Ministry of Health and Sanitation, Sierra Leone
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1. Study Identification

Unique Protocol Identification Number
NCT05949190
Brief Title
Improving Cognition and Gestational Duration With Targeted Nutrition
Acronym
COGENT
Official Title
Improving Cognition and Gestational Duration With Targeted Nutrition
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 18, 2023 (Actual)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Project Peanut Butter, Open Philanthropy, United States Department of Agriculture (USDA), Ministry of Health and Sanitation, Sierra Leone

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition in Pregnancy, Preterm Birth, Child Development, Postpartum Depression, Antepartum Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
2x2 factorial design
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
1600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline) and CBT
Arm Type
Experimental
Arm Description
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.
Arm Title
M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline) and no CBT
Arm Type
Experimental
Arm Description
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.
Arm Title
M-RUSF (Maternal Ready-to-use Supplementary Food without DHA/EPA/choline and CBT
Arm Type
Experimental
Arm Description
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.
Arm Title
M-RUSF (Maternal Ready-to-use Supplementary Food without DHA/EPA/choline and no CBT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
M-RUSF+ (Maternal Ready-to-Use Supplementary Food + DHA/EPA/choline)
Intervention Description
Balanced energy protein supplement with added DHA/EPA/choline, micronutrients
Intervention Type
Dietary Supplement
Intervention Name(s)
M-RUSF (Maternal Ready-to-Use Supplementary Food)
Intervention Description
Balanced energy protein supplement with added micronutrients
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
1g dose
Intervention Type
Drug
Intervention Name(s)
Albendazole
Intervention Description
400mg dose
Intervention Type
Drug
Intervention Name(s)
Sulfadoxine pyrimethamine
Intervention Description
Monthly, 1,500/75mg dose
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy
Intervention Description
Novel program developed for illiterate end-users
Intervention Type
Other
Intervention Name(s)
Insecticide-treated mosquito net
Intervention Description
Bed net to prevent malaria
Primary Outcome Measure Information:
Title
Gestational duration
Description
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)
Title
Malawi Developmental Assessment Tool (MDAT) global z-score
Description
Infant global age-adjusted z-score on MDAT
Time Frame
9 months post-birth
Title
Adapted Patient Health Questionnaire-9 (PHQ-9) score
Description
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
Secondary Outcome Measure Information:
Title
Early preterm birth
Description
Birth < 34 weeks gestational age
Time Frame
Enrollment to 34 weeks' gestation
Title
Birth weight
Description
Infant weight at birth
Time Frame
Birth
Title
Birth length
Description
Infant length at birth
Time Frame
Birth
Title
Low birth weight
Description
Birth weight < 2.5 kg
Time Frame
Birth
Title
Malawi Developmental Assessment Test sub-domain z-scores
Description
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
Title
Preterm birth
Description
Birth < 37 weeks gestational age
Time Frame
Enrollment to 37 weeks' gestation
Title
Neonatal mortality
Description
Infant death within the first 28 days of life
Time Frame
Birth to 28 days of age
Title
Infant mortality
Description
Infant death
Time Frame
Birth to end of follow-up (9 months)
Title
Depressive symptoms
Description
Adapted Patient Health Questionnaire-9 score (range 0-27, higher scores are worse)
Time Frame
Through study completion, an average of 1.25 years
Title
Maternal and infant DHA status
Description
Plasma, Red Blood Cell (RBC) membrane DHA status
Time Frame
From Enrollment to delivery, an average of 15 weeks
Title
Maternal and infant choline status
Description
Blood choline concentration
Time Frame
From Enrollment to delivery, an average of 15 weeks
Title
Maternal weight gain
Description
Average weekly weight gain
Time Frame
From Enrollment to delivery, an average of 15 weeks
Title
Post-term delivery
Description
Delivery > 42 weeks' gestation
Time Frame
From Enrollment to delivery, an average of 15 weeks
Title
Depression incidence
Description
Adapted PHQ-9 >= 9
Time Frame
8 weeks from time of depression diagnosis
Title
Birth chest circumference
Description
Infant chest circumference
Time Frame
Birth
Title
Birth thigh circumference
Description
Infant thigh circumference
Time Frame
Birth
Title
Birth head circumference
Description
Infant head circumference
Time Frame
Birth
Title
Infant weight at 6 weeks, 3 months, 6 months, 9 months
Description
Infant weight
Time Frame
Birth to 9 months
Title
Infant length at 6 weeks, 3 months, 6 months, 9 months
Description
Infant length
Time Frame
Birth to 9 months
Title
Infant length-for-age z-score at 6 weeks, 3 months, 6 months, 9 months
Description
Infant length-for-age z-score
Time Frame
Birth to 9 months
Title
Gestational duration
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark J Manary, MD
Phone
+1 314-454-2341
Email
manarymj@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark J Manary, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bandajuma
City
Bandajuma
State/Province
Southern
Country
Sierra Leone
Individual Site Status
Recruiting
Facility Name
Bendu Malen
City
Bendu
State/Province
Southern
Country
Sierra Leone
Individual Site Status
Recruiting
Facility Name
Blama Massaquoi
City
Blama Massaquoi
State/Province
Southern
Country
Sierra Leone
Individual Site Status
Recruiting
Facility Name
Futa Peje
City
Futa Peje
State/Province
Southern
Country
Sierra Leone
Individual Site Status
Recruiting
Facility Name
Gbondapi
City
Gbondapi
State/Province
Southern
Country
Sierra Leone
Individual Site Status
Recruiting
Facility Name
Nyandehun Malen
City
Nyandehun
State/Province
Southern
Country
Sierra Leone
Individual Site Status
Recruiting
Facility Name
Potoru
City
Potoru
State/Province
Southern
Country
Sierra Leone
Individual Site Status
Recruiting
Facility Name
Pujehun Static
City
Pujehun
State/Province
Southern
Country
Sierra Leone
Individual Site Status
Recruiting
Facility Name
Sahn Malen
City
Sahn
State/Province
Southern
Country
Sierra Leone
Individual Site Status
Recruiting
Facility Name
Zimmi
City
Zimmi
State/Province
Southern
Country
Sierra Leone
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected Individual; Patient Data (IPD).
IPD Sharing Time Frame
Within 12 months of primary publication

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Improving Cognition and Gestational Duration With Targeted Nutrition

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