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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 : November 7, 2019
Sponsor:
Collaborator:
Academy of Nutrition and Dietetics
Information provided by (Responsible Party):
Wuqu' Kawoq, Maya Health Alliance

Tracking Information
First Submitted Date  ICMJE September 26, 2018
First Posted Date  ICMJE September 28, 2018
Last Update Posted Date November 7, 2019
Actual Study Start Date  ICMJE January 20, 2018
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
  • 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
  • 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
  • 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)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating a Family-based Nutrition and Garden Intervention in Rural Guatemala
Official Title  ICMJE Evaluating a Family-based Nutrition and Garden Intervention in Rural Guatemala
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Malnutrition
  • Dietary Modification
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Dietary Supplement: Standard of care nutrition support
    • Behavioral: Home-based nutrition education
  • 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)
    Interventions:
    • Dietary Supplement: Standard of care nutrition support
    • Behavioral: Home-based nutrition education
    • Behavioral: Home-based family gardening
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 27, 2018)
280
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 24 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anne Kraemer Diaz +011 502 7840 3112 anne@wuqukawoq.org
Listed Location Countries  ICMJE Guatemala
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03689504
Other Study ID Numbers  ICMJE WK-2018-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Analytic Code
Time Frame: Supporting data will be shared indefinitely on public data repositories at the time of manuscript publication.
Access Criteria: Publicly available
Responsible Party Wuqu' Kawoq, Maya Health Alliance
Study Sponsor  ICMJE Wuqu' Kawoq, Maya Health Alliance
Collaborators  ICMJE Academy of Nutrition and Dietetics
Investigators  ICMJE
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
PRS Account Wuqu' Kawoq, Maya Health Alliance
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP