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Promoting Physical Growth and Positive Development in Severely Stunted Guatemalan Children

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ClinicalTrials.gov Identifier: NCT02509936
Recruitment Status : Completed
First Posted : July 28, 2015
Last Update Posted : December 6, 2016
Sponsor:
Collaborators:
Universidad del Valle, Guatemala
Grand Challenges Canada
Information provided by (Responsible Party):
Wuqu' Kawoq, Maya Health Alliance

Brief 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.

Condition or disease Intervention/treatment Phase
Malnutrition Developmental Disabilities Behavioral: Home-based nutrition education Dietary Supplement: Standard-of-care nutrition support Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : August 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Arm Intervention/treatment
Active Comparator: Standard of Care Arm
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.
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)
Experimental: Home-based Education
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.
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)



Primary Outcome Measures :
  1. Height/length for age Z score [ Time Frame: Baseline, 6 months ]
    Change in height/length over 6 months. Tool used is the WHO Child Growth Reference Standards.


Secondary Outcome Measures :
  1. Cognitive Development [ Time Frame: Baseline, 6 months ]
    Change in cognitive development score over 6 months. Tool used: Bayley III Cognitive Development Observational Checklist

  2. Socioemotional development [ Time Frame: Baseline, 6 months ]
    Change in socioemotional development score over 6 months. Tool used: Bayley III Socioemotional Development Parent Questionnaire

  3. Gross motor development [ Time Frame: Baseline, 6 months ]
    Change in gross motor development score over 6 months. Tool used: Bayley III Gross Motor Observational Checklist

  4. Fine motor development [ Time Frame: Baseline, 6 months ]
    Change in fine motor development score over 6 months. Tool used: Bayley III Fine Motor Observational Checklist

  5. Receptive Language Development [ Time Frame: Baseline, 6 months ]
    Change in receptive language development score over 6 months. Tool used: Bayley III Receptive Language Observational Checklist

  6. Expressive Language Development [ Time Frame: Baseline, 6 months ]
    Change in expressive language development score over 6 months. Tool used: Bayley III Expressive Language Observational Checklist



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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02509936


Locations
Guatemala
Wuqu' Kawoq
Tecpan, Chimaltenango, Guatemala
Sponsors and Collaborators
Wuqu' Kawoq, Maya Health Alliance
Universidad del Valle, Guatemala
Grand Challenges Canada
Investigators
Principal Investigator: Peter Rohloff, MD PhD Wuqu' Kawoq
Principal Investigator: Maria Grazioso, PhD Universidad del Valle, Guatemala

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wuqu' Kawoq, Maya Health Alliance
ClinicalTrials.gov Identifier: NCT02509936     History of Changes
Other Study ID Numbers: WK-2015-003
First Posted: July 28, 2015    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Malnutrition
Developmental Disabilities
Nutrition Disorders
Neurodevelopmental Disorders
Mental Disorders
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs