Overview

This trial has been completed.

Conditions malnutrition, developmental disabilities
Treatments home-based nutrition education, standard-of-care nutrition support
Sponsor Wuqu' Kawoq, Maya Health Alliance
Collaborator Universidad del Valle, Guatemala
Start date August 2015
End date October 2016
Trial size 324 participants
Trial identifier NCT02509936, WK-2015-003

Summary

This study seeks to evaluate the impact of an intensive home-based education intervention targeting severely stunted Guatemalan children for catch up growth and improved development. Half of the children in the study will receive standard of care, which includes micronutrient supplementation and a food ration. The other half of children in the study will receive, in addition to the above, home-based dietary assessment and individualized parental nutrition education.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
In this arm enrolled children will receive the national standard of care for growth support, which includes growth monitoring, a food ration, and a multiple micronutrient powder supplement.
standard-of-care nutrition support
Subjects will be provided with a standard food ration and with a multiple micronutrient powder dietary supplement (Chispitas)
(Experimental)
In the intervention arm, children will receive the national standard of care for growth support, which includes growth monitoring, a food ration, and a multiple micronutrient powder supplement. In addition, they will receive monthly home visits from a community health promoter who will provide detailed dietary assessments and individualized dietary coaching and education to parents.
home-based nutrition education
Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
standard-of-care nutrition support
Subjects will be provided with a standard food ration and with a multiple micronutrient powder dietary supplement (Chispitas)

Primary Outcomes

Measure
Height/length for age Z score
time frame: Baseline, 6 months

Secondary Outcomes

Measure
Cognitive Development
time frame: Baseline, 6 months
Socioemotional development
time frame: Baseline, 6 months
Gross motor development
time frame: Baseline, 6 months
Fine motor development
time frame: Baseline, 6 months
Receptive Language Development
time frame: Baseline, 6 months
Expressive Language Development
time frame: Baseline, 6 months

Eligibility Criteria

Male or female participants from 6 months up to 24 months old.

Inclusion Criteria: - Child aged 6-24 months at time of enrollment - Height/length for age Z score of less than -2.5 - Child lives with parent/legal guardian Exclusion Criteria: - Presence of acute malnutrition (weight for length/height Z score of less than -2) - Presence of other severe medical illness (e.g. congenital heart disease, genetic abnormality)

Additional Information

Official title Crowd Funding and Social Networks as a Novel Mechanism to Promote Sustainable Physical Growth and Positive Psychosocial and Neurodevelopmental Outcomes in Severely Stunted Guatemalan Children
Principal investigator Peter Rohloff, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Wuqu' Kawoq, Maya Health Alliance.