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

Study Overview
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Brief Summary
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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: Evaluate the impact of the garden intervention on maternal and child dietary diversity, child growth and household food insecurity. Use the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework to conduct a preliminary implementation analysis, to guide a future, well-controlled study.

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

Conditions
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Malnutrition, Dietary Modification

Intervention / Treatment
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* Dietary Supplement: Standard of care nutrition support
* Behavioral: Home-based nutrition education
* Behavioral: Home-based family gardening


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>The standard of care is an intensive individualized home-based nutrition education program, together with a home food ration and micronutrient supplement, delivered by frontline workers for 6 months. | Dietary Supplement: Standard of care nutrition support<br>* Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)<br>Behavioral: Home-based nutrition education<br>* Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.<br>|
| Experimental: Home Garden Intervention<br>This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education) | Dietary Supplement: Standard of care nutrition support<br>* Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)<br>Behavioral: Home-based nutrition education<br>* Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.<br>Behavioral: Home-based family gardening<br>* Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Guatemala, indigenous, dietary diversity, chronic malnutrition, Maya, agriculture, behavior change, food insecurity