N/A
N=324
Promoting Physical Growth and Positive Development in Severely Stunted Guatemalan Children
Malnutrition · Developmental Disabilities
Bottom Line
View on ClinicalTrials.gov: NCT02509936 ↗Enrolled (actual)
324
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Change in Height/Length for Age Z Score — -0.02; 0.05 Z scores
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Home-based nutrition education (Behavioral); Standard-of-care nutrition support (Dietary_supplement)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Wuqu' Kawoq, Maya Health Alliance
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Height/Length for Age Z Score |
-0.02; 0.05 | — |
| SECONDARY Cognitive Development |
0.38; 0.28 | — |
| SECONDARY Socioemotional Development |
0.44; 0.20 | — |
| SECONDARY Gross Motor Development |
0.51; 0.70 | — |
| SECONDARY Fine Motor Development |
0.27; 0.4 | — |
| SECONDARY Receptive Language Development |
0.56; 0.49 | — |
| SECONDARY Expressive Language Development |
0.63; 0.69 | — |
| SECONDARY Minimum Diet Diversity |
115; 135 | — |
| SECONDARY Minimum Meal Frequency |
131; 129 | — |
| SECONDARY Minimum Acceptable Diet |
104; 123 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT02509936). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.