Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202306540202462 Date of Registration: 06/06/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Improving Cognition and Gestational Duration with Targeted Nutrition (COGENT)
Official scientific title Improving Cognition and Gestational Duration with Targeted Nutrition (COGENT)
Brief summary describing the background and objectives of the trial 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. Studies in well-nourished pregnant women suggest antenatal supplementation with docosahexaenoic acid (DHA) prolongs gestation and reduces early preterm birth, but its effects in undernourished populations are unclear. There is also evidence that antenatal DHA supplementation might promote offspring cognitive development in certain settings. In addition, ante- and postpartum depression are underrecognized and undertreated in rural Sub-Saharan Africa. Cognitive behavioral therapy (CBT) has been shown to improve ante- and postpartum depression, but existing programs require literacy. Our group developed an adapted protocol for CBT designed for illiterate end-users, but its efficacy is unknown. The trials objectives are threefold. 1. To determine whether the addition of the 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 (called M-RUSF+) will prolong gestation when compared with a similar supplementary food except that it lacks DHA, EPA, and choline (called M-RUSF). 2. To determine whether M-RUSF+ will improve infant cognitive development at 9 months of age when compared with M-RUSF. 3. To determine whether a novel CBT program will improve ante- and post-partum depression?
Type of trial RCT
Acronym (If the trial has an acronym then please provide) COGENT
Disease(s) or condition(s) being studied Neonatal Diseases,Nutritional, Metabolic, Endocrine,Paediatrics,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 03/07/2023
Actual trial start date 18/08/2023
Anticipated date of last follow up 31/01/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 1600
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
007052023 Sierra Leone Ethics and Scientific Review Committee
202305139 Washington University Institutional Review Board
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Maternal Ready to Use Supplementary Food PLUS and Cognitive Behavioral Therapy Factorial 1. Maternal Ready-to-Use Supplementary Food+ (M-RUSF+) will be provided from enrollment until delivery. Factorial 2. Cognitive Behavioral Therapy (CBT) will be provided from enrollment until 6 months postpartum among participants who develop ante- or postpartum depression. Factorial 1. A daily dose of 500mg DHA, 500mg EPA, and 550mg choline will be added to the maternal balanced energy-protein Ready-to-Use Supplementary Food (M-RUSF+). One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the UNICEF/WHO/UN 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 receive 6 sessions of CBT adopted for use in illiterate populations will be provided. 400
Experimental Group Maternal Ready to Use Supplementary Food PLUS and no Cognitive Behavioral Therapy Factorial 1. Maternal Ready-to-Use Supplementary Food+ (M-RUSF+) will be provided from enrollment until delivery. Factorial 2. Cognitive Behavioral Therapy (CBT) will not be provided. Factorial 1. A daily dose of 500mg DHA, 500mg EPA, and 550mg choline will be added to the maternal balanced energy-protein Ready-to-Use Supplementary Food (M-RUSF+). One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the UNICEF/WHO/UN 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. 400
Experimental Group Maternal Ready to Use Supplementary Food and Cognitive Behavioral Therapy Factorial 1. Maternal Ready-to-Use Supplementary Food (M-RUSF) will be provided from enrollment until delivery. Factorial 2. Cognitive Behavioral Therapy (CBT) will be provided from enrollment until 6 months postpartum among participants who develop ante- or postpartum depression. Factorial 1. A balanced energy-protein maternal Ready-to-Use Supplementary Food (M-RUSF) without added DHA/EPA/choline. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the UNICEF/WHO/UN 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 receive 6 sessions of CBT adopted for use in illiterate populations will be provided. 400
Control Group Maternal Ready to Use Supplementary Food and no CBT Factorial 1. Maternal Ready-to-Use Supplementary Food (M-RUSF) will be provided from enrollment until delivery. Factorial 2. Cognitive Behavioral Therapy (CBT) will not be provided. Factorial 1. A balanced energy-protein maternal Ready-to-Use Supplementary Food (M-RUSF) without added DHA/EPA/choline. One sachet (daily dose) will provide 520 Kcal, 18g protein, and the same quantities of micronutrients as the UNICEF/WHO/UN 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. 400 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 ≥ 16 years of age will be allowed to consent for themselves 1b. Women < 16 years of age 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 within planned study timeframe 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 ≥ 16 years of age will be allowed to consent for themselves 1b. Women < 16 years of age 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 within planned study timeframe 3. Patient Health Questionnaire-9 score ≥ 9 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 Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 13 Year(s) 50 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/05/2023 Sierra Leone Ethics and Scientific Review Committee
Ethics Committee Address
Street address City Postal code Country
Directorate of Training and Research, 5th Floor, East Wing, Youyi Building, Brookfields, Freetown Freetown NA Sierra Leone
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Gestational Duration. This will be determined by 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 with singleton pregnancies. Enrollment to birth
Primary Outcome Infant Malawi Developmental Assessment Tool global z-score 9 months post-birth
Primary Outcome Adapted Patient Health Questionnaire-9 score 8 weeks after diagnosis of ante- or postpartum depression
Secondary Outcome Early preterm birth. This is defined as birth before 34 weeks gestational age. Enrollment to 34 weeks gestational age
Secondary Outcome Infant birth weight Birth
Secondary Outcome Infant birth length Birth
Secondary Outcome Low birth weight, defined as birth weight under 2.5 kg Birth
Secondary Outcome Preterm birth, defined as birth before 37 weeks gestational age Enrollment to 37 weeks gestational age
Secondary Outcome Neonatal mortality, defined as infant death within the first 28 days of life Birth to 28 days of age
Secondary Outcome Infant death Birth to end of follow up, 9 months
Secondary Outcome Maternal depressive symptoms, defined by adapted PHQ-9 score Enrollment to end of follow-up, up to 9 months after delivery
Secondary Outcome Maternal and infant DHA status Enrollment to delivery
Secondary Outcome Maternal and infant choline status Enrollment to delivery
Secondary Outcome Maternal weight gain, defined as average weekly weight gain Enrollment to delivery
Secondary Outcome Depression incidence, defined as adapted PHQ-9 score greater than or equal to 9 Enrollment to end of follow up, up to 9 months after delivery
Secondary Outcome Birth infant chest circumference Birth
Secondary Outcome Birth infant thigh circumference Birth
Secondary Outcome Birth infant head circumference Birth
Secondary Outcome Malawi Developmental Assessment Tool sub-domain z scores, gross motor, fine motor, language, and social domains 9 months after birth
Secondary Outcome Infant weight at 6 weeks, 3 months, 6 months, and 9 months Birth to 9 months
Secondary Outcome Infant length at 6 weeks, 3 months, 6 months, and 9 months Birth to 9 months
Secondary Outcome Gestational duration. For this secondary, all enrolled mothers who have singleton births will be included. Enrollment to birth
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sahn Malen N/A NA Sierra Leone
Static Pujehun NA NA Sierra Leone
Bendu Malen NA NA Sierra Leone
Potoru NA NA Sierra Leone
Bandajuma NA NA Sierra Leone
Zimmi NA NA Sierra Leone
Gbondapi NA NA Sierra Leone
Futa Peje NA NA Sierra Leone
Nyandehun NA NA Sierra Leone
Blama Massaqoui NA NA Sierra Leone
FUNDING SOURCES
Name of source Street address City Postal code Country
Open Philanthropy 182 Howard Street, 225 San Francisco 94105 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Washington University in St. Louis 1 Brookings Drive Saint Louis 63130 United States of America University
COLLABORATORS
Name Street address City Postal code Country
University of Texas at Austin 110 Inner Campus Drive Austin 78712 United States of America
Sierra Leone Ministry of Health and Sanitation 4th and 5th floors, Youyi Building Freetown Sierra Leone
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mark Manary manarymj@wustl.edu +13144542341 600 South Euclid Avenue
City Postal code Country Position/Affiliation
St. Louis 63110 United States of America Professor of Pediatrics
Role Name Email Phone Street address
Public Enquiries Donna Wegner donnarwegner@wustl.edu +13144547162 600 South Euclid Avenue
City Postal code Country Position/Affiliation
St. Louis United States of America Project Manager in the Department of Pediatrics
Role Name Email Phone Street address
Scientific Enquiries Kevin Stephenson k.stephenson@wustl.edu +13144545685 600 South Taylor Avenue, Suite 155
City Postal code Country Position/Affiliation
St. Louis United States of America Instructor of Medicine
Role Name Email Phone Street address
Scientific Enquiries Aminata Koroma shamitamin@gmail.com +23276300770 Jomo Kenyatta Road
City Postal code Country Position/Affiliation
Freetown Sierra Leone Director of Food and Nutrition in the Sierra Leone Ministry of Health and Sanitation
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual patient data will be available. All of the individual participant data collected during the trial will be shared, after deidentification. The study protocol, statistical analysis plan, informed consent form, and analytic code will be shared. The data will be available within 12 months of the primary trial publication. Anyone who wishes to access the data will have access, for any type of analysis purpose. The data will be posted on a public repository. Analytic Code,Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 12 months of primary trial publication None
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information