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Promoting Physical Growth and Positive Development in Severely Stunted Guatemalan Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02509936
Recruitment Status : Completed
First Posted : July 28, 2015
Results First Posted : November 26, 2019
Last Update Posted : November 26, 2019
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

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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. Change in 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. Change values calculated as: 6 month (z-score) minus Baseline (z-score).


Secondary Outcome Measures :
  1. Cognitive Development [ Time Frame: Baseline, 6 months ]
    Change in cognitive development Z score over 6 months. Tool used: Bayley III Cognitive Development Observational Checklist. Z-scores derived internally from the entire baseline measurement data set for the study. A z-score of 0 is equal to the mean cognitive score for the study population at baseline. Lower numbers indicate values lower than the baseline study population mean mean and higher numbers indicate values higher than this mean. Higher values above zero are indicative of cognitive scores higher than mean baseline score for the study population. Lower values below zero are indicative of cognitive scores lower than mean baseline score for the study population. For outcomes, change values are calculated as 6 month (z-score) minus Baseline (z-score)

  2. Socioemotional Development [ Time Frame: Baseline, 6 months ]
    Change in socioemotional development score over 6 months. Tool used: Bayley III Socioemotional Development Parent Questionnaire. Z-scores derived internally from the entire baseline measurement data set for the study. A z-score of 0 is equal to the mean socioemotional score for the study population at baseline. Lower numbers indicate values lower than the baseline study population mean mean and higher numbers indicate values higher than this mean. Higher values above zero are indicative of socioemotional scores higher than mean baseline score for the study population. Lower values below zero are indicative of socioemotional scores lower than mean baseline score for the study population. For outcomes, change values are calculated as 6 month (z-score) minus Baseline (z-score)

  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. Z-scores derived internally from the entire baseline measurement data set for the study. A z-score of 0 is equal to the mean gross motor score for the study population at baseline. Lower numbers indicate values lower than the baseline study population mean mean and higher numbers indicate values higher than this mean. Higher values above zero are indicative of gross motor scores higher than mean baseline score for the study population. Lower values below zero are indicative of gross motor scores lower than mean baseline score for the study population. For outcomes, change values are calculated as 6 month (z-score) minus Baseline (z-score)

  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. Z-scores derived internally from the entire baseline measurement data set for the study. A z-score of 0 is equal to the mean fine motor score for the study population at baseline. Lower numbers indicate values lower than the baseline study population mean mean and higher numbers indicate values higher than this mean. Higher values above zero are indicative of fine motor scores higher than mean baseline score for the study population. Lower values below zero are indicative of fine motor scores lower than mean baseline score for the study population. For outcomes, change values are calculated as 6 month (z-score) minus Baseline (z-score)

  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. Z-scores derived internally from the entire baseline measurement data set for the study. A z-score of 0 is equal to the mean receptive language score for the study population at baseline. Lower numbers indicate values lower than the baseline study population mean mean and higher numbers indicate values higher than this mean. Higher values above zero are indicative of receptive language scores higher than mean baseline score for the study population. Lower values below zero are indicative of receptive language scores lower than mean baseline score for the study population. For outcomes, change values are calculated as 6 month (z-score) minus Baseline (z-score)

  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. Z-scores derived internally from the entire baseline measurement data set for the study. A z-score of 0 is equal to the mean expressive language score for the study population at baseline. Lower numbers indicate values lower than the baseline study population mean mean and higher numbers indicate values higher than this mean. Higher values above zero are indicative of expressive language scores higher than mean baseline score for the study population. Lower values below zero are indicative of expressive language scores lower than mean baseline score for the study population. For outcomes, change values are calculated as 6 month (z-score) minus Baseline (z-score)

  7. Minimum Diet Diversity [ Time Frame: 0 months, 6 months ]
    Number of participants meeting the age appropriate minimum number of food groups consumed per day. This is defined according to the WHO's Infant and Young Child Feeding Indicators guidelines as greater or equal to 4 food groups consumed in the last 24 - hour period. The 7 possible food groups are: (1) grains, roots, tubers; (2) legumes, nuts; (3) dairy products; (4) flesh foods; (5) eggs; (6) vitamin A-rich fruits and vegetables; (7) other fruits and vegetables.

  8. Minimum Meal Frequency [ Time Frame: 0 months, 6 months ]
    Number of participants meetings the age-appropriate number of solid meals per day. This is defined according to the WHO's Infant and Young Child Feeding Indicators guidelines as 2 solid meals in the last 24-hour period for breastfed infants 6-8 months old; 3 solid meals in the last 24-hour period for breastfed infants 9 months or older; 4 solid meals in the last 24-hour period for non-breastfed infants.

  9. Minimum Acceptable Diet [ Time Frame: 0 months, 6 months ]
    Number of participants who meet both minimum diet diversity and minimum meal frequency indicators. Minimum diet diversity and minimum meal frequency are both defined according to the WHO's Infant and Young Child Feeding Indicators guidelines. See the entries for minimum diet diversity and minimum meal frequency in this record for more details.



Information from the National Library of Medicine

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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
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Guatemala
Wuqu' Kawoq
Tecpan, Chimaltenango, Guatemala
Sponsors and Collaborators
Wuqu' Kawoq, Maya Health Alliance
Universidad del Valle, Guatemala
Grand Challenges Canada
Investigators
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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):
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Responsible Party: Wuqu' Kawoq, Maya Health Alliance
ClinicalTrials.gov Identifier: NCT02509936    
Other Study ID Numbers: WK-2015-003
First Posted: July 28, 2015    Key Record Dates
Results First Posted: November 26, 2019
Last Update Posted: November 26, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Malnutrition
Developmental Disabilities
Nutrition Disorders
Neurodevelopmental Disorders
Mental Disorders