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

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition; Dietary Modification
• Intervention / Treatment: Dietary supplement: Standard of care nutrition support; Behavioral: Home-based nutrition education; Behavioral: Home-based family gardening

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Guatemala
  • Chimaltenango
    • Tecpán Guatemala, Chimaltenango, Guatemala
      • Wuqu' Kawoq

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; 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; 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.
Experimental: Home Garden Intervention; 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; 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.; Behavioral: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wuqu' Kawoq, Maya Health Alliance
• Collaborators: Academy of Nutrition and Dietetics
• Investigators: Principal Investigator: Beth Jimenez, RDN PhD, University of New Mexico; Study Director: Andrea Guzman, RDN, Wuqu' Kawoq

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2018
• Primary Completion (Actual): May 11, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: September 27, 2018
• First Posted (Actual): September 28, 2018

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Guatemala; behavior change; food insecurity; indigenous; dietary diversity; chronic malnutrition; Maya; agriculture
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: WK-2018-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Fully de-identified demographic, clinical, and outcomes will be made available on a public data repository after completion of primary analysis and at the time of publication of results manuscripts.
• IPD Sharing Time Frame: Supporting data will be shared indefinitely on public data repositories at the time of manuscript publication.
• IPD Sharing Access Criteria: Publicly available
• IPD Sharing Supporting Information Type: Study Protocol; Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No