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

Primary Purpose

Malnutrition, Dietary Modification

Status

Completed

Phase

Not Applicable

Locations

Guatemala

Study Type

Interventional

Intervention

Standard of care nutrition support

Home-based nutrition education

Home-based family gardening

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring Guatemala, indigenous, dietary diversity, chronic malnutrition, Maya, agriculture, behavior change, food insecurity

Eligibility Criteria

6 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Wuqu' Kawoq

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

Home Garden Intervention

Arm Description

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.

This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)

Outcomes

Primary Outcome Measures

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

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

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

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

Secondary Outcome Measures

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)

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

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

Full Information

NCT ID

NCT03689504

First Posted

September 26, 2018

Last Updated

October 11, 2021

Sponsor

Wuqu' Kawoq, Maya Health Alliance

Collaborators

Academy of Nutrition and Dietetics

1. Study Identification

Unique Protocol Identification Number

NCT03689504

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

January 20, 2018 (Actual)

Primary Completion Date

May 11, 2020 (Actual)

Study Completion Date

July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wuqu' Kawoq, Maya Health Alliance

Collaborators

Academy of Nutrition and Dietetics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malnutrition, Dietary Modification

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard of Care

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Home Garden Intervention

Arm Type

Experimental

Arm Description

This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education)

Intervention Type

Dietary Supplement

Intervention Name(s)

Standard of care nutrition support

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Home-based nutrition education

Intervention Description

Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.

Intervention Type

Behavioral

Intervention Name(s)

Home-based family gardening

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Baseline, 6 months

Title

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

Description

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

Time Frame

Baseline, 6 months

Title

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

Description

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

Time Frame

Baseline, 6 months

Title

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

Description

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

Time Frame

Baseline, 6 months

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

0 months (baseline), 6 months

Title

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

Description

Time Frame

0 months (Baseline), 6 months

Title

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

Description

Time Frame

Baseline, 6 months

Title

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

Description

Raw count of total crop species cultivated in the home

Time Frame

Baseline, 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

24 Months

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Rohloff, MD PhD

Organizational Affiliation

Wuqu' Kawoq

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Beth Jimenez, RDN PhD

Organizational Affiliation

University of New Mexico

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Andrea Guzman, RDN

Organizational Affiliation

Wuqu' Kawoq

Official's Role

Study Director

Facility Information:

Facility Name

Wuqu' Kawoq

City

Tecpán Guatemala

State/Province

Chimaltenango

Country

Guatemala

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

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

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