The INICIO-Guatemala Study
ConditionDevelopment, Child
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-50
SponsorUniversity of North Carolina, Chapel Hill
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Factorial
Treatments tested in this trial
Nutri-INICIO
Dietary supplementNutri-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.
Mediational Intervention for Sensitizing Caregivers (MISC
BehavioralThe 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.
Active Control
Other interventionThe 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.
Treatment groups
400 Participants
are divided into 4 treatment groupsGroup A: Nutritional InterventionExperimental treatment 1 intervention
Group B: Caregiver InterventionExperimental treatment 1 intervention
Group C: Nutritional Intervention and Caregiver InterventionExperimental treatment 2 interventions
Group D: Active ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mullen Scales of Early Learning (MSEL) Early Learning Composite Score (ELC)
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.
Time frame
24 months of ageSecondary outcomes
1
Mullen Scales of Early Learning Gross Motor Domain
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.
Time frame
24 months2
Mullen Scales of Early Learning Fine Motor Domain
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.
Time frame
24 months3
Mullen Scales of Early Learning Visual Reception Domain
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.
Time frame
24 months4
Mullen Scales of Early Learning Receptive Language Domain
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.
Time frame
24 monthsSponsors and contacts
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University of North Carolina, Chapel Hill
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov