Clinical trial NCT02509936: 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
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Developmental Disabilities
Lead sponsor: Wuqu' Kawoq, Maya Health Alliance
Sponsor class: OTHER
Collaborators: name: Universidad del Valle, Guatemala
name: Grand Challenges Canada
First posted: 2015-07-28
Enrollment: 324
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change in Height/Length for Age Z Score
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Cognitive Development
timeFrame: Baseline, 6 months
measure: Socioemotional Development
timeFrame: Baseline, 6 months
measure: Gross Motor Development
timeFrame: Baseline, 6 months
measure: Fine Motor Development
timeFrame: Baseline, 6 months
measure: Receptive Language Development
timeFrame: Baseline, 6 months
measure: Expressive Language Development
timeFrame: Baseline, 6 months
measure: Minimum Diet Diversity
timeFrame: 0 months, 6 months
measure: Minimum Meal Frequency
timeFrame: 0 months, 6 months
measure: Minimum Acceptable Diet
timeFrame: 0 months, 6 months
Other outcomes:
Locations:
city: Tecpan
country: Guatemala
facility: Wuqu' Kawoq
state: Chimaltenango
Study officials:
affiliation: Wuqu' Kawoq
name: Peter Rohloff, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad del Valle, Guatemala
name: Maria Grazioso, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.