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

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ClinicalTrials.gov Identifier: NCT03689504
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : February 19, 2019
Sponsor:
Collaborator:
Academy of Nutrition and Dietetics
Information provided by (Responsible Party):
Wuqu' Kawoq, Maya Health Alliance

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. 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.

Condition or disease Intervention/treatment Phase
Malnutrition Dietary Modification Dietary Supplement: Standard of care nutrition support Behavioral: Home-based nutrition education Behavioral: Home-based family gardening Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating a Family-based Nutrition and Garden Intervention in Rural Guatemala
Actual Study Start Date : January 20, 2018
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

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.




Primary Outcome Measures :
  1. Change from baseline in mean number of food groups consumed per day at 18 months - child [ Time Frame: Baseline, 18 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 18 months - child [ Time Frame: Baseline, 18 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 18 months [ Time Frame: Baseline, 18 months ]
    Standardized food insecurity score, usng the FAO Global Food Insecurity Experience Scale (possible score range 0-8)

  4. Change from baseline in mean number of food groups consumed per day at 18 months - female head of household [ Time Frame: Baseline, 18 months ]
    Calculated from the FAO Minimum Dietary Diversity for Women dietary recall


Secondary Outcome Measures :
  1. Change in Height/length for age Z score from baseline to 18 months [ Time Frame: Baseline,18 months ]
    Z scores are derived from the WHO Child Growth Reference Standards

  2. Change in Weight for age Z score from baseline to 18 months [ Time Frame: Baseline, 18 months ]
    Z scores are derived from the WHO Child Growth Reference Standards

  3. Change in weight for /height/length Z score from baseline to 18 months [ Time Frame: Baseline, 18 months ]
    Z scores are derived from the WHO Child Growth Reference Standards

  4. Mean change in Household Crop Species from baseline to 18 months Diversity Score [ Time Frame: Baseline, 18 months ]
    Raw count of total crop species cultivated in the home



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689504


Contacts
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Contact: Anne Kraemer Diaz +011 502 7840 3112 anne@wuqukawoq.org

Locations
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Guatemala
Wuqu' Kawoq Recruiting
Tecpán Guatemala, Chimaltenango, Guatemala
Contact: Anne Kraemer Díaz, MA    502-3005-8042    anne@wuqukawoq.org   
Sponsors and Collaborators
Wuqu' Kawoq, Maya Health Alliance
Academy of Nutrition and Dietetics
Investigators
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Principal Investigator: Peter Rohloff, MD PhD Wuqu' Kawoq
Principal Investigator: Beth Jimenez, RDN PhD University of New Mexico
Study Director: Andrea Guzman, RDN Wuqu' Kawoq

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Responsible Party: Wuqu' Kawoq, Maya Health Alliance
ClinicalTrials.gov Identifier: NCT03689504     History of Changes
Other Study ID Numbers: WK-2018-002
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: 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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wuqu' Kawoq, Maya Health Alliance:
Guatemala
indigenous
dietary diversity
chronic malnutrition
Maya
agriculture
behavior change
food insecurity

Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders