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Promoting Physical Growth and Positive Development in Severely Stunted Guatemalan Children

Primary Purpose

Malnutrition, Developmental Disabilities

Status
Completed
Phase
Not Applicable
Locations
Guatemala
Study Type
Interventional
Intervention
Home-based nutrition education
Standard-of-care nutrition support
Sponsored by
Wuqu' Kawoq, Maya Health Alliance
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition

Eligibility Criteria

6 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Wuqu' Kawoq

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care Arm

Home-based Education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Height/Length for Age Z Score
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

Cognitive Development
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
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
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
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
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
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
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
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
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.

Full Information

First Posted
July 17, 2015
Last Updated
November 6, 2019
Sponsor
Wuqu' Kawoq, Maya Health Alliance
Collaborators
Universidad del Valle, Guatemala, Grand Challenges Canada
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1. Study Identification

Unique Protocol Identification Number
NCT02509936
Brief Title
Promoting Physical Growth and Positive Development in Severely Stunted Guatemalan Children
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 Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuqu' Kawoq, Maya Health Alliance
Collaborators
Universidad del Valle, Guatemala, Grand Challenges Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Developmental Disabilities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
324 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care Arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Home-based Education
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Home-based nutrition education
Intervention Description
Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard-of-care nutrition support
Intervention Description
Subjects will be provided with a standard food ration and with a multiple micronutrient powder dietary supplement (Chispitas)
Primary Outcome Measure Information:
Title
Change in Height/Length for Age Z Score
Description
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).
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Cognitive Development
Description
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)
Time Frame
Baseline, 6 months
Title
Socioemotional Development
Description
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)
Time Frame
Baseline, 6 months
Title
Gross Motor Development
Description
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)
Time Frame
Baseline, 6 months
Title
Fine Motor Development
Description
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)
Time Frame
Baseline, 6 months
Title
Receptive Language Development
Description
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)
Time Frame
Baseline, 6 months
Title
Expressive Language Development
Description
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)
Time Frame
Baseline, 6 months
Title
Minimum Diet Diversity
Description
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.
Time Frame
0 months, 6 months
Title
Minimum Meal Frequency
Description
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.
Time Frame
0 months, 6 months
Title
Minimum Acceptable Diet
Description
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.
Time Frame
0 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Rohloff, MD PhD
Organizational Affiliation
Wuqu' Kawoq
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria Grazioso, PhD
Organizational Affiliation
Universidad del Valle, Guatemala
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wuqu' Kawoq
City
Tecpan
State/Province
Chimaltenango
Country
Guatemala

12. IPD Sharing Statement

Citations:
PubMed Identifier
30306144
Citation
Martinez B, Cardona S, Rodas P, Lubina M, Gonzalez A, Farley Webb M, Grazioso MDP, Rohloff P. Developmental outcomes of an individualised complementary feeding intervention for stunted children: a substudy from a larger randomised controlled trial in Guatemala. BMJ Paediatr Open. 2018 Oct 3;2(1):e000314. doi: 10.1136/bmjpo-2018-000314. eCollection 2018.
Results Reference
derived
PubMed Identifier
29719876
Citation
Martinez B, Webb MF, Gonzalez A, Douglas K, Grazioso MDP, Rohloff P. Complementary feeding intervention on stunted Guatemalan children: a randomised controlled trial. BMJ Paediatr Open. 2018 Apr 27;2(1):e000213. doi: 10.1136/bmjpo-2017-000213. eCollection 2018.
Results Reference
derived

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Promoting Physical Growth and Positive Development in Severely Stunted Guatemalan Children

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