Promoting Physical Growth and Positive Development in Severely Stunted Guatemalan Children

• 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: Wuqu' Kawoq, Maya Health Alliance
• Collaborators: Universidad del Valle, Guatemala; Grand Challenges Canada
• Information provided by (Responsible Party): Wuqu' Kawoq, Maya Health Alliance

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.

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

Study Design

• 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

Arms and Interventions

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)

Outcome Measures

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.

Eligibility Criteria

• 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)

Contacts and Locations

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Wuqu' Kawoq, Maya Health Alliance
• ClinicalTrials.gov Identifier: NCT02509936
• Other Study ID Numbers: WK-2015-003
• First Posted: July 28, 2015
• Results First Posted: November 26, 2019
• Last Update Posted: November 26, 2019
• Last Verified: November 2019

Additional relevant MeSH terms:

Malnutrition; Developmental Disabilities; Nutrition Disorders; Neurodevelopmental Disorders; Mental Disorders