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Grandi Byen: Test of an Integrated Parenting and Nutrition Intervention

NCT04785352 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2024-10-15

No results posted yet for this study

Summary

The premise of this trial is that a combined nutrition (eggs) and parenting behavior intervention (responsive parenting combined with the reinforcement of animal source foods and improved WASH) will synergistically result in improved child growth, development, and reduced enteric disease outcomes over and above a nutrition only intervention and standard well baby care.

This study is a 3-arm longitudinal randomized controlled trial (RCT) to compare the following groups for effectiveness in reducing young child stunted growth and enhancing overall development:1) standard well-baby care, (n=200); 2) nutrition intervention (one egg per day for 6 months), (n=200); and 3) multicomponent Grandi Byen intervention (responsive parenting, nutrition, hygiene + one egg per day for 6 months), (n=200).

Infants will be enrolled between 6-8 months of age and followed longitudinally for one year.

Conditions

  • Malnutrition, Child
  • Development, Child
  • Parenting

Interventions

DIETARY_SUPPLEMENT

Nutrition Intervention

One egg per day for six months

BEHAVIORAL

Grandi Byen

Multicomponent intervention on responsive parenting, nutrition, hygiene + one egg per day for 6 months

Sponsors & Collaborators

  • Hôpital Universitaire Justinien

    collaborator UNKNOWN

  • Université Publique du Nord au Cap-Haïtien

    collaborator UNKNOWN

  • Konbit Sante

    collaborator UNKNOWN

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Lora L Iannotti, PhD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
6 Months
Max Age
8 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Haiti

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04785352 on ClinicalTrials.gov