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

NCT03689504 | Completed Results

• 1 other identifier: WK-2018-002
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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. 1.Evaluate the impact of the garden intervention on maternal and child dietary diversity, child growth and household food insecurity.
2. 2.Use the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework to conduct a preliminary implementation analysis, to guide a future, well-controlled study.

Conditions

Malnutrition; Dietary Modification

Keywords

Guatemala; indigenous; dietary diversity; chronic malnutrition; Maya; agriculture; behavior change; food insecurity

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Change in Height/Length for Age Z Score From Baseline to 6 Months

  0 months (baseline), 6 months

• Change in Weight for Age Z Score From Baseline to 6 Months

  0 months (Baseline), 6 months

• Change in Weight for Height/Length Z Score From Baseline to 6 Months

  Baseline, 6 months

• Mean Change in Household Crop Species From Baseline to 6 Months Diversity Score

  Baseline, 6 months

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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; Behavioral: Home-based nutrition education

Home Garden Intervention

EXPERIMENTAL

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; Behavioral: Home-based nutrition education; Behavioral: Home-based family gardening

Interventions

Standard of care nutrition support DIETARY_SUPPLEMENT

Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)

Home Garden Intervention; Standard of Care

Home-based nutrition education BEHAVIORAL

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 Garden Intervention; Standard of Care

Home-based family gardening BEHAVIORAL

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

Home Garden Intervention

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wuqu' Kawoq, Maya Health Alliance: lead
• Academy of Nutrition and Dietetics: collaborator

Study Sites (1)

Wuqu' Kawoq

Tecpán Guatemala, Departamento de Chimaltenango, Guatemala

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Peter Rohloff, Chief Medical Officer
• Organization: Wuqu' Kawoq

peter@wuqukawoq.org

011-502-4958-1253

Study Officials

• Peter Rohloff, MD PhD

  Wuqu' Kawoq

  PRINCIPAL INVESTIGATOR

• Beth Jimenez, RDN PhD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

• Andrea Guzman, RDN

  Wuqu' Kawoq

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 28, 2018
• Study Start: January 20, 2018
• Primary Completion: May 11, 2020
• Study Completion: July 31, 2020
• Last Updated: November 9, 2021
• Results First Posted: November 9, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Supporting data will be shared indefinitely on public data repositories at the time of manuscript publication.
• Access Criteria: Publicly available

Locations

GU (1)