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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
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

Tracking Information
First Submitted Date  ICMJE July 17, 2015
First Posted Date  ICMJE July 28, 2015
Results First Submitted Date  ICMJE August 19, 2019
Results First Posted Date  ICMJE November 26, 2019
Last Update Posted Date November 26, 2019
Study Start Date  ICMJE August 2015
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2019)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 24, 2015)
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 History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2019)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2015)
  • Cognitive Development [ Time Frame: Baseline, 6 months ]
    Change in cognitive development score over 6 months. Tool used: Bayley III Cognitive Development Observational Checklist
  • Socioemotional development [ Time Frame: Baseline, 6 months ]
    Change in socioemotional development score over 6 months. Tool used: Bayley III Socioemotional Development Parent Questionnaire
  • 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
  • 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
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Promoting Physical Growth and Positive Development in Severely Stunted Guatemalan Children
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Malnutrition
  • Developmental Disabilities
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: Standard-of-care nutrition support
  • 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.
    Interventions:
    • Behavioral: Home-based nutrition education
    • Dietary Supplement: Standard-of-care nutrition support
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2016)
324
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2015)
322
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 24 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Guatemala
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02509936
Other Study ID Numbers  ICMJE WK-2015-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wuqu' Kawoq, Maya Health Alliance
Study Sponsor  ICMJE Wuqu' Kawoq, Maya Health Alliance
Collaborators  ICMJE
  • Universidad del Valle, Guatemala
  • Grand Challenges Canada
Investigators  ICMJE
Principal Investigator: Peter Rohloff, MD PhD Wuqu' Kawoq
Principal Investigator: Maria Grazioso, PhD Universidad del Valle, Guatemala
PRS Account Wuqu' Kawoq, Maya Health Alliance
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP