Dietary Modification, Malnutrition
Conditions
Keywords
Guatemala, indigenous, dietary diversity, chronic malnutrition, Maya, agriculture, behavior change, food insecurity
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.
Interventions
DIETARY_SUPPLEMENTStandard 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)
BEHAVIORALHome-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.
BEHAVIORALHome-based family gardening
Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.
Sponsors
Academy of Nutrition and Dietetics
Wuqu' Kawoq, Maya Health Alliance
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 24 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Female Head of Household | Baseline, 6 months | Calculated from the Food and Agriculture Organization's Minimum Dietary Diversity for Women dietary recall |
| Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Child | Baseline, 6 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 6 Months - Child | Baseline, 6 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 6 Months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Height/Length for Age Z Score From Baseline to 6 Months | 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) |
| Change in Weight for Age Z Score From Baseline to 6 Months | 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) |
| Change in Weight for Height/Length Z Score From Baseline to 6 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) |
| Mean Change in Household Crop Species From Baseline to 6 Months Diversity Score | Baseline, 6 months | Raw count of total crop species cultivated in the home |
Countries
Guatemala
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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)
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. | 70 |
| 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)
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)
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.
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. | 70 |
| Total | 140 |
Baseline characteristics
| Characteristic | Home Garden Intervention | Total | Standard of Care |
|---|---|---|---|
| Age, Continuous | 343 days | 353 days | 376 days |
| Length for age Z score | -3.20 Z score | -3.15 Z score | -3.05 Z score |
| Minimum acceptable diet | 48 Participants | 82 Participants | 34 Participants |
| Race/Ethnicity, Customized Maya ethnicity/language preference | 68 Participants | 133 Participants | 65 Participants |
| Region of Enrollment Guatemala | 70 participants | 140 participants | 70 participants |
| Sex: Female, Male Female | 29 Participants | 61 Participants | 32 Participants |
| Sex: Female, Male Male | 41 Participants | 79 Participants | 38 Participants |
| Weight for age Z score | -1.58 Z score | -1.56 Z score | -1.55 Z score |
| Weight for length Z score | 0.32 Z score | 0.3 Z score | 0.18 Z score |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 70 |
| other Total, other adverse events | 0 / 70 | 0 / 70 |
| serious Total, serious adverse events | 0 / 70 | 0 / 70 |
Outcome results
Primary
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
Time frame: Baseline, 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Child | 0.6 food groups | Standard Deviation 1.84 |
| Home Garden Intervention | Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Child | 1.29 food groups | Standard Deviation 1.59 |
Primary
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
Time frame: Baseline, 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Female Head of Household | -0.01 food groups | Standard Deviation 1.88 |
| Home Garden Intervention | Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Female Head of Household | 0.42 food groups | Standard Deviation 1.75 |
Primary
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
Time frame: Baseline, 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Change From Baseline in Mean Number of Solid Meals Consumed Per Day at 6 Months - Child | 0.81 solid meals | Standard Deviation 1.61 |
| Home Garden Intervention | Change From Baseline in Mean Number of Solid Meals Consumed Per Day at 6 Months - Child | 1.11 solid meals | Standard Deviation 1.45 |
Primary
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
Time frame: Baseline, 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Change From Baseline in Raw Household Food Insecurity Score at 6 Months | -0.55 score on a scale | Standard Deviation 1.86 |
| Home Garden Intervention | Change From Baseline in Raw Household Food Insecurity Score at 6 Months | -0.84 score on a scale | Standard Deviation 2.1 |
Secondary
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)
Time frame: 0 months (baseline), 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Change in Height/Length for Age Z Score From Baseline to 6 Months | -0.21 change in Z score | Standard Deviation 0.49 |
| Home Garden Intervention | Change in Height/Length for Age Z Score From Baseline to 6 Months | -0.07 change in Z score | Standard Deviation 0.51 |
Secondary
Change in Weight 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)
Time frame: 0 months (Baseline), 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Change in Weight for Age Z Score From Baseline to 6 Months | -0.22 Change in Z score | Standard Deviation 0.39 |
| Home Garden Intervention | Change in Weight for Age Z Score From Baseline to 6 Months | -0.12 Change in Z score | Standard Deviation 0.29 |
Secondary
Change in Weight for Height/Length 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)
Time frame: Baseline, 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Change in Weight for Height/Length Z Score From Baseline to 6 Months | -0.38 Change in Z score | Standard Deviation 0.64 |
| Home Garden Intervention | Change in Weight for Height/Length Z Score From Baseline to 6 Months | -0.24 Change in Z score | Standard Deviation 0.54 |
Secondary
Mean Change in Household Crop Species From Baseline to 6 Months Diversity Score
Raw count of total crop species cultivated in the home
Time frame: Baseline, 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Mean Change in Household Crop Species From Baseline to 6 Months Diversity Score | -1.1 crop species | Standard Deviation 4.15 |
| Home Garden Intervention | Mean Change in Household Crop Species From Baseline to 6 Months Diversity Score | 4.62 crop species | Standard Deviation 4.66 |