Promoting Physical Growth and Positive Development in Severely Stunted Guatemalan Children

NCT02509936 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2019-11-26

Study results available
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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.

Conditions

  • Malnutrition
  • Developmental Disabilities

Interventions

BEHAVIORAL

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.

DIETARY_SUPPLEMENT

Standard-of-care nutrition support

Subjects will be provided with a standard food ration and with a multiple micronutrient powder dietary supplement (Chispitas)

Sponsors & Collaborators

  • Universidad del Valle, Guatemala

    collaborator OTHER
  • Grand Challenges Canada

    collaborator OTHER
  • Wuqu' Kawoq, Maya Health Alliance

    lead OTHER

Principal Investigators

  • Peter Rohloff, MD PhD · Wuqu' Kawoq

  • Maria Grazioso, PhD · Universidad del Valle, Guatemala

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • Guatemala

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 NCT02509936 on ClinicalTrials.gov