CompletedNot Applicable

Grandi Byen: Test of an Integrated Parenting and Nutrition Intervention

Haiti600 participantsStarted 2021-07-01

Plain-language 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.

Who can participate

Age range

6 Months – 8 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Mothers/Caregivers 18 years or older of infants ages 6-8 months * Infants ages 6-8 months * Living in Petite Anse, Fort Saint Michel, Madeline, or similiar communities (Cap-Haitien, Haiti) Exclusion Criteria: * Multi-birth infant (twin, triplet, etc.) * congenital health condition * severe disabilities * severely malnourished (WLZ\<-3) * child has an allergy to animal-source foods (specifically eggs, milk, or fish).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Child Growth: Changes in length-for-age Z-score (LAZ)

Timeframe: Baseline and months 3, 6, 9, and 12

Child Growth: Changes in weight-for-age Z-score (WAZ)

Timeframe: Baseline and months 3, 6, 9, and 12

Child Growth: Changes in head circumference-for-age Z-score (HCZ)

Timeframe: Baseline and months 3, 6, 9, and 12

Child Development: Changes in ASQ- Socio-Emotional (ASQ-SE) score

Timeframe: Baseline and months 6 and 12

Child Development: Changes in ASQ Communication score

Timeframe: Baseline and months 6 and 12

Child Development: Changes in ASQ Gross Motor score

Timeframe: Baseline and months 6 and 12

Child Development: Changes in ASQ Fine Motor score

Timeframe: Baseline and months 6 and 12

Trial details

NCT IDNCT04785352

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-01

View on ClinicalTrials.gov More Malnutrition, Child trials

Plain-language summary

Who can participate

Age range

6 Months – 8 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Child Growth: Changes in length-for-age Z-score (LAZ)

Timeframe: Baseline and months 3, 6, 9, and 12

Child Growth: Changes in weight-for-age Z-score (WAZ)

Timeframe: Baseline and months 3, 6, 9, and 12

Child Growth: Changes in head circumference-for-age Z-score (HCZ)

Timeframe: Baseline and months 3, 6, 9, and 12

Child Development: Changes in ASQ- Socio-Emotional (ASQ-SE) score

Timeframe: Baseline and months 6 and 12

Child Development: Changes in ASQ Communication score

Timeframe: Baseline and months 6 and 12

Child Development: Changes in ASQ Gross Motor score

Timeframe: Baseline and months 6 and 12

Child Development: Changes in ASQ Fine Motor score

Timeframe: Baseline and months 6 and 12