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Completed

NCT Number: NCT03689504

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.

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Key information

Conditions

Malnutrition Dietary Modification Nutrition Disorders Nutritional and Metabolic Diseases

Age range

6 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wuqu' Kawoq

Tecpán Guatemala, Departamento de Chimaltenango, Guatemala

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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-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-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.

Primary outcomes

  1. Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Child

    Time frame: Baseline, 6 months

    Calculated from the World Health Organization Infant and Young Child Feeding Indicators 24 hour diet recall tool

  2. Change From Baseline in Mean Number of Solid Meals Consumed Per Day at 6 Months - Child

    Time frame: Baseline, 6 months

    Calculated from the World Health Organization Infant and Young Child Feeding Indicators 24 hour diet recall tool

  3. Change From Baseline in Raw Household Food Insecurity Score at 6 Months

    Time frame: Baseline, 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

  4. Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Female Head of Household

    Time frame: Baseline, 6 months

    Calculated from the Food and Agriculture Organization's Minimum Dietary Diversity for Women dietary recall

Secondary outcomes

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

    Time frame: 0 months (baseline), 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)

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

    Time frame: 0 months (Baseline), 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)

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

    Time frame: Baseline, 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)

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

    Time frame: Baseline, 6 months

    Raw count of total crop species cultivated in the home

Sponsors and collaborators

Lead sponsor

Wuqu' Kawoq, Maya Health Alliance

Other

Collaborators

  • Academy of Nutrition and Dietetics

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 28, 2018
Registry last updated
Nov 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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