Ignite Creation Date:
2024-05-06 @ 3:30 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02302729
Status:
COMPLETED
Last Update Posted:
2019-08-16
First Post:
2014-10-31
Brief Title:
Early Child Development and Nutrition in Guatemala
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Professor Department of Pediatrics University of Maryland School of Medicine
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Over 200 million children under the age of 5 years in low and middle-income countries do not reach their developmental potential largely due to lack of adequate nutrients and lack of psychosocial stimulation Stunting length-for-age -2 z-scores is an indication of chronic undernutrition Guatemala has the high rates of stunting in the Western Hemisphere over 40 This trial examines the effect of providing a micronutrient powder manufactured in Guatemala vs placebo and an early learning environment vs no early learning environment on the growth health and development of young children in Guatemala
Detailed Description:
The plan is to implement a clustered randomized placebo controlled trial with an infant phase 6-12 months of age and a preschool phase 36-48 months of age For the infant phase the investigators will use ProPAN Process for the Promotion of Child Feeding in the development of the evaluation and intervention with modifications as necessary for the Guatemalan context ProPAN is a tool developed and distributed by the Pan American Health Organization to develop implement and evaluate interventions and programs to improve infant and young child diet and feeding ProPAN includes four modules
Module 1 Assessment Module 2 Testing Recipes and Recommendations Module 3 Intervention Module 4 Monitoring and Evaluation
For the preschool phase the investigators will use an evidence-based school readiness intervention Little By Little that has been shown to be effective with Hispanic preschoolers The intervention will be implemented through the Association for the Prevention and Study of HIVAIDS who will train and supervise the community health workers By working directly with a local non-profit organization the project will be well positioned to inform strategies to scale up the intervention on a community wide basis if beneficial effects are shown
The project examines the effects of an integrated intervention that includes both micronutrient powder added to food and responsive feeding for infants or school readiness for preschoolers The primary aim is to examine how an integrated micronutrients responsive feedingschool readiness intervention changes the development primary outcome growth and micronutrient status secondary outcomes of young children The investigators will focus on infants 6-12 months when the risk for micronutrient deficiencies is high as they transition from breast feeding to complementary feeding and the family diet The investigators will focus on preschoolers 36-48 months to examine if micronutrients a school readiness intervention can improve childrens school readiness skills The design includes neighborhood clusters randomized into four groups 1 micronutrients plus responsive feedingschool readiness 2 micronutrients only 3 placebo plus responsive feedingschool readiness and 4 placebo only
The investigators will test the following hypotheses
1 Children in the two micronutrients groups have better change from baseline in development primary outcome growth and micronutrient status secondary oitcomes than children in the two placebo groups
2 Mothers and children in the two responsive feedingschool readiness groups have better change from baseline measures of child development than those in the two control groups
3 The impact of the responsive feedingschool readiness intervention is greater in the micronutrient groups than in the placebo groups Children in the micronutrients plus responsive feedingschool readiness group have better change from baseline in development than children in any of the other three groups
Module 1 Assessment Module 2 Testing Recipes and Recommendations Module 3 Intervention Module 4 Monitoring and Evaluation
For the preschool phase the investigators will use an evidence-based school readiness intervention Little By Little that has been shown to be effective with Hispanic preschoolers The intervention will be implemented through the Association for the Prevention and Study of HIVAIDS who will train and supervise the community health workers By working directly with a local non-profit organization the project will be well positioned to inform strategies to scale up the intervention on a community wide basis if beneficial effects are shown
The project examines the effects of an integrated intervention that includes both micronutrient powder added to food and responsive feeding for infants or school readiness for preschoolers The primary aim is to examine how an integrated micronutrients responsive feedingschool readiness intervention changes the development primary outcome growth and micronutrient status secondary outcomes of young children The investigators will focus on infants 6-12 months when the risk for micronutrient deficiencies is high as they transition from breast feeding to complementary feeding and the family diet The investigators will focus on preschoolers 36-48 months to examine if micronutrients a school readiness intervention can improve childrens school readiness skills The design includes neighborhood clusters randomized into four groups 1 micronutrients plus responsive feedingschool readiness 2 micronutrients only 3 placebo plus responsive feedingschool readiness and 4 placebo only
The investigators will test the following hypotheses
1 Children in the two micronutrients groups have better change from baseline in development primary outcome growth and micronutrient status secondary oitcomes than children in the two placebo groups
2 Mothers and children in the two responsive feedingschool readiness groups have better change from baseline measures of child development than those in the two control groups
3 The impact of the responsive feedingschool readiness intervention is greater in the micronutrient groups than in the placebo groups Children in the micronutrients plus responsive feedingschool readiness group have better change from baseline in development than children in any of the other three groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None