Clinical trial NCT03689504: 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
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Dietary Modification
Keywords: Guatemala
indigenous
dietary diversity
chronic malnutrition
Maya
agriculture
behavior change
food insecurity
Lead sponsor: Wuqu' Kawoq, Maya Health Alliance
Sponsor class: OTHER
Collaborators: name: Academy of Nutrition and Dietetics
First posted: 2018-09-28
Enrollment: 140
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Child
timeFrame: Baseline, 6 months
measure: Change From Baseline in Mean Number of Solid Meals Consumed Per Day at 6 Months - Child
timeFrame: Baseline, 6 months
measure: Change From Baseline in Raw Household Food Insecurity Score at 6 Months
timeFrame: Baseline, 6 months
measure: Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Female Head of Household
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change in Height/Length for Age Z Score From Baseline to 6 Months
timeFrame: 0 months (baseline), 6 months
measure: Change in Weight for Age Z Score From Baseline to 6 Months
timeFrame: 0 months (Baseline), 6 months
measure: Change in Weight for Height/Length Z Score From Baseline to 6 Months
timeFrame: Baseline, 6 months
measure: Mean Change in Household Crop Species From Baseline to 6 Months Diversity Score
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Tecpán Guatemala
country: Guatemala
facility: Wuqu' Kawoq
state: Chimaltenango
Study officials:
affiliation: Wuqu' Kawoq
name: Peter Rohloff, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of New Mexico
name: Beth Jimenez, RDN PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuqu' Kawoq
name: Andrea Guzman, RDN
role: STUDY_DIRECTOR
References: