Development, Child
Conditions
Keywords
Nutritional intervention, Microbiome, Caregiving, Rice bran, Bean flour
Brief summary
The goal of this randomized controlled trial (RCT) is to evaluate an intestinal health-targeted nutritional intervention and a caregiver training program, individually and combined, on childhood neurodevelopment (ND) in rural southwest Guatemala. The main questions it aims to answer are: what is the impact of an intestinal-targeted nutritional intervention on child ND and what is the added benefit of a caregiver intervention on child ND. The primary endpoint is the Mullen Scales of Early Learning (MSEL) Early Learning Composite (ELC) Score at 24 months. Secondary endpoints include MSEL subdomain scores (gross motor, fine motor, expressive language, receptive language, visual reception). Researchers will compare child ND between the four study arms using a factorial design: (1) intestinal health-targeted nutritional intervention, (2) caregiving training program, (3) combined intestinal health-targeted nutritional intervention and caregiving training program, and (4) active control. Participants will be randomized as mother-child dyads at 6 months of age and followed until 24 months of age.
Detailed description
The investigators plan to enroll 400 pregnant women during the second trimester of pregnancy; randomization of mother-child dyads into the four study groups will occur at 6 months of infant age; infants will be followed through 24 months of age. Randomization will occur using a 2×2 factorial design into the four groups. The nutritional intervention, Nutri-INICIO, is a fortified maize-bean-rice bran porridge intended to improve intestinal health and growth. The caregiver intervention, the Mediational Intervention for Sensitizing Caregivers (MISC), consists of twice-monthly, video-feedback-based training sessions from 12-24 months to enhance responsive caregiving.
Interventions
DIETARY_SUPPLEMENTNutri-INICIO
Nutri-INICIO, is a fortified maize-bean-rice bran porridge intended to improve intestinal health and growth. Caregivers will be instructed on Nutri-INICIO preparation methods. Children 6-11 months old will receive a 20 gram daily serving, children 12-17 months old will receive a 30 gram daily serving, children 18-24 months old will receive a 40 gram daily serving. The investigators will ensure receipt of the essential components of the ministry of health childcare package including micronutrient supplementation and anti-parasite prophylaxis. Participants will also receive anemia screening and treatment as appropriate.
BEHAVIORALMediational Intervention for Sensitizing Caregivers (MISC
The Mediational Intervention for Sensitizing Caregivers (MISC) consists of twice-monthly, video-feedback-based training sessions from 12-24 months to enhance responsive caregiving. The investigators will ensure receipt of the essential components of the ministry of health childcare package including micronutrient supplementation and anti-parasite prophylaxis. Participants will also receive anemia screening and treatment as appropriate.
OTHERActive Control
The control group will receive the same number of visits as the experimental groups and the investigators will ensure receipt of the essential components of the ministry of health childcare package including micronutrient supplementation and anti-parasite prophylaxis. Participants will also receive anemia screening and treatment as appropriate.
Sponsors
University of North Carolina, Chapel Hill
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
2x2
Eligibility
Sex/Gender
ALL
Age
0 Days to 50 Years
Healthy volunteers
Yes
Inclusion criteria
The investigators will offer enrollment to pregnant in the Trifinio region of southwest Guatemala and will enroll their newborns after birth. Inclusion Criteria: * Pregnant woman in the second trimester of pregnancy * Pregnant woman =\>15 years of age * Plan to live in the study area during pregnancy and up to 24 months after giving birth * Newborns born to enrolled women will join the study at birth
Exclusion criteria
* Pregnant woman less than 15 years of age * Planning to move during the study * Not willing or able to participate in the interventions, including following instructions for preparing the food, completing the adherence forms, participating in the caregiving sessions * Women who do not sign the consent form for their or their child's participation * Infants who require a hospital stay after birth of 21 days or longer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mullen Scales of Early Learning (MSEL) Early Learning Composite Score (ELC) | 24 months of age | Comprehensive neurodevelopment score, combining scores from the four "cognitive" domains of fine motor, visual reception, receptive language, and expressive language. Z-scores for each of the 4 domains will be calculated by regressing raw score for age. The mean of those four Z-scores will make up the Early Learning Composite Z-score. The score will range from -3 to +3, with the higher score indicating more advanced neurodevelopment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mullen Scales of Early Learning Gross Motor Domain | 24 months | The MSEL gross motor domain measures the child's gross motor development. A Z-score will calculated by regressing raw score for age. The score will range from -3 to +3, with the higher score indicating more advanced gross motor development. |
| Mullen Scales of Early Learning Fine Motor Domain | 24 months | The MSEL fine motor domain measures the child's find motor development. A Z-score will calculated by regressing raw score for age. The score will range from -3 to +3, with the higher score indicating more advanced fine motor development. |
| Mullen Scales of Early Learning Visual Reception Domain | 24 months | The MSEL visual reception domain measures the child's find motor development. A Z-score will calculated by regressing raw score for age. The score will range from -3 to +3, with the higher score indicating more advanced fine motor development. |
| Mullen Scales of Early Learning Receptive Language Domain | 24 months | The MSEL receptive language domain measures the child's find motor development. A Z-score will calculated by regressing raw score for age. The score will range from -3 to +3, with the higher score indicating more advanced receptive language development. |
| Mullen Scales of Early Learning Expressive Language Domain | 24 months | The MSEL expressive language domain measures the child's find motor development. A Z-score will calculated by regressing raw score for age. The score will range from -3 to +3, with the higher score indicating more advanced expressive language development. |
Countries
Guatemala
Contacts
CONTACTNeudy Rojop, MPH
PRINCIPAL_INVESTIGATORSylvia Becker-Dreps, MD, MPH
University of North Carolina, Chapel Hill
PRINCIPAL_INVESTIGATORAmy K Connery, PsyD
University of Colorado School of Medicine
PRINCIPAL_INVESTIGATORDiva Mirella Barrientos Giron, MD
Fundacion para la Salud Integral de los Guatemaltecos
Outcome results
None listed