Evaluating a Family-based Nutrition and Garden Intervention in Rural Guatemala

Malnutrition Clinical Trial

Official title:

Evaluating a Family-based Nutrition and Garden Intervention in Rural Guatemala

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03689504
• Other study ID #: WK-2018-002
• Status: Completed
• Phase: N/A
• Start date: January 20, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: October 2021
• Source: Wuqu' Kawoq, Maya Health Alliance
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot quasi-experimental study to evaluate the impact of adding a family garden intervention to an existing wrap-around nutrition intervention for children with chronic malnutrition and their family. The existing nutrition intervention is provided by community health workers affiliated with Wuqu' Kawoq | Maya Health Alliance. A single community in rural Guatemala will participate in the intervention, with the goal to recruit approximately 70 families in the combined nutrition/garden intervention. A nearby community, also participating in the nutrition intervention, will serve as a nonrandom contemporaneous control.

Aims of the study include:

1. Evaluate the impact of the garden intervention on maternal and child dietary diversity, child growth and household food insecurity.

2. Use the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework to conduct a preliminary implementation analysis, to guide a future, well-controlled study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 31, 2020
• Est. primary completion date: May 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 24 Months

Eligibility

Inclusion Criteria:

• Children who are already scheduled to be enrolled in Maya Health Alliance's intensive home-based nutrition program (non-investigational, standard of care) who are 6-24 months of age at the time of enrollment with a height-for-age Z scores of <= -2.5

• At least one caregiver willing to provide written informed consent

• Caregiver of a child enrolled in the study (for caregiver/head of household outcomes), including women who may be pregnant

• Planned residence in the study area for the next 18 months

Exclusion Criteria:

• Children with acute malnutrition (weight for length Z scores of <= -2.0)

• Children with a severe medical illness that affects growth (e.g., heart disease, kidney disease, genetic condition) as determined by a Maya Health Alliance staff physician.

• Caregivers with cognitive impairments that prevent them from being able to provide informed consent

Related Conditions & MeSH terms

• Dietary Modification
• Malnutrition

Intervention

Dietary Supplement:
• Standard of care nutrition support
Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)

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.
• Home-based family gardening
Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.

Locations

Country	Name	City	State
Guatemala	Wuqu' Kawoq	Tecpán Guatemala	Chimaltenango

Sponsors (2)

Lead Sponsor	Collaborator
Wuqu' Kawoq, Maya Health Alliance	Academy of Nutrition and Dietetics

Country where clinical trial is conducted

Guatemala, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Child	Calculated from the World Health Organization Infant and Young Child Feeding Indicators 24 hour diet recall tool	Baseline, 6 months
Primary	Change From Baseline in Mean Number of Solid Meals Consumed Per Day at 6 Months - Child	Calculated from the World Health Organization Infant and Young Child Feeding Indicators 24 hour diet recall tool	Baseline, 6 months
Primary	Change From Baseline in Raw Household Food Insecurity Score at 6 Months	Standardized food insecurity score, using the Food and Agriculture Organization's Global Food Insecurity Experience Scale (possible score range 0-8), higher scores indicate more food insecurity	Baseline, 6 months
Primary	Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Female Head of Household	Calculated from the Food and Agriculture Organization's Minimum Dietary Diversity for Women dietary recall	Baseline, 6 months
Secondary	Change in Height/Length for Age Z Score From Baseline to 6 Months	These are differences from 0 to 6 months (baseline to 6 months of intervention) z-scores calculated against the World Health Organization pediatric growth reference population (https://www.who.int/tools/child-growth-standards/standards)	0 months (baseline), 6 months
Secondary	Change in Weight for Age Z Score From Baseline to 6 Months	These are differences from 0 to 6 months (baseline to 6 months of intervention) z-scores calculated against the World Health Organization pediatric growth reference population (https://www.who.int/tools/child-growth-standards/standards)	0 months (Baseline), 6 months
Secondary	Change in Weight for Height/Length Z Score From Baseline to 6 Months	These are differences from 0 to 6 months (baseline to 6 months of intervention) z-scores calculated against the World Health Organization pediatric growth reference population (https://www.who.int/tools/child-growth-standards/standards)	Baseline, 6 months
Secondary	Mean Change in Household Crop Species From Baseline to 6 Months Diversity Score	Raw count of total crop species cultivated in the home	Baseline, 6 months