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
1 other identifier
interventional
324
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2015
CompletedFirst Posted
Study publicly available on registry
July 28, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedResults Posted
Study results publicly available
November 26, 2019
CompletedNovember 26, 2019
November 1, 2019
1.2 years
July 17, 2015
August 19, 2019
November 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Cognitive Development
Baseline, 6 months
Socioemotional Development
Baseline, 6 months
Gross Motor Development
Baseline, 6 months
Fine Motor Development
Baseline, 6 months
Receptive Language Development
Baseline, 6 months
- +4 more secondary outcomes
Study Arms (2)
Standard of Care Arm
ACTIVE COMPARATORIn 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.
Home-based Education
EXPERIMENTALIn 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.
Interventions
Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
Subjects will be provided with a standard food ration and with a multiple micronutrient powder dietary supplement (Chispitas)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wuqu' Kawoq, Maya Health Alliancelead
- Universidad del Valle, Guatemalacollaborator
- Grand Challenges Canadacollaborator
Study Sites (1)
Wuqu' Kawoq
Tecpán Guatemala, Departamento de Chimaltenango, Guatemala
Related Publications (2)
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.
PMID: 30306144DERIVEDMartinez 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.
PMID: 29719876DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Peter Rohloff
- Organization
- Wuqu' Kawoq | Maya Health Alliance
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Rohloff, MD PhD
Wuqu' Kawoq
- PRINCIPAL INVESTIGATOR
Maria Grazioso, PhD
Universidad del Valle, Guatemala
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2015
First Posted
July 28, 2015
Study Start
August 1, 2015
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
November 26, 2019
Results First Posted
November 26, 2019
Record last verified: 2019-11