Promoting Physical Growth and Positive Development in Severely Stunted Guatemalan Children

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

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition; Developmental Disabilities
• Intervention / Treatment: Behavioral: Home-based nutrition education; Dietary supplement: Standard-of-care nutrition support

• Study Type: Interventional
• Enrollment (Actual): 324
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Guatemala
  • Chimaltenango
    • Tecpan, Chimaltenango, Guatemala
      • Wuqu' Kawoq

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 2 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline, 6 months
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)	Baseline, 6 months
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)	Baseline, 6 months
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)	Baseline, 6 months
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)	Baseline, 6 months
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)	Baseline, 6 months
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.	0 months, 6 months
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.	0 months, 6 months
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.	0 months, 6 months

Collaborators and Investigators

• Sponsor: Wuqu' Kawoq, Maya Health Alliance
• Collaborators: Grand Challenges Canada; Universidad del Valle, Guatemala
• Investigators: Principal Investigator: Maria Grazioso, PhD, Universidad del Valle, Guatemala

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (ACTUAL): October 1, 2016
• Study Completion (ACTUAL): October 1, 2016

Study Registration Dates

• First Submitted: July 17, 2015
• First Submitted That Met QC Criteria: July 24, 2015
• First Posted (ESTIMATE): July 28, 2015

Study Record Updates

• Last Update Posted (ACTUAL): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 6, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nutrition Disorders; Neurodevelopmental Disorders; Malnutrition; Developmental Disabilities
• Other Study ID Numbers: WK-2015-003