Neonatal Diseases Nutritional, Metabolic, Endocrine Pregnancy and Childbirth Paediatrics
Conditions
Interventions
Maternal Ready to Use Supplementary Food PLUS and Cognitive Behavioral Therapy
Maternal Ready to Use Supplementary Food PLUS and no Cognitive Behavioral Therapy
Maternal Ready to Use Supplementary Food and Cognitive Behavioral Therapy
Maternal Ready to Use Supplementary Food and no CBT
Sponsors
Washington University in St. Louis
Eligibility
Sex/Gender
Female
Inclusion 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: 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;Infant Malawi Developmental Assessment Tool global z-score ;Adapted Patient Health Questionnaire-9 score | — |
Secondary
| Measure | Time frame |
|---|---|
| Early preterm birth. This is defined as birth before 34 weeks gestational age. ;Infant birth weight;Infant birth length;Low birth weight, defined as birth weight under 2.5 kg;Preterm birth, defined as birth before 37 weeks gestational age;Neonatal mortality, defined as infant death within the first 28 days of life;Infant death;Maternal depressive symptoms, defined by adapted PHQ-9 score;Maternal and infant DHA status;Maternal and infant choline status;Maternal weight gain, defined as average weekly weight gain;Depression incidence, defined as adapted PHQ-9 score greater than or equal to 9;Birth infant chest circumference;Birth infant thigh circumference;Birth infant head circumference;Malawi Developmental Assessment Tool sub-domain z scores, gross motor, fine motor, language, and social domains;Infant weight at 6 weeks, 3 months, 6 months, and 9 months;Infant length at 6 weeks, 3 months, 6 months, and 9 months ;Gestational duration. For this secondary, all enrolled mothers who have singleton births will be included. | — |
Countries
Sierra Leone
Contacts
Public ContactDonna Wegner
Project Manager in the Department of Pediatrics
Outcome results
None listed