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| Name | Class |
|---|---|
| Academy of Nutrition and Dietetics | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | 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. |
|
| Home Garden Intervention | Experimental | This arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of care nutrition support | Dietary Supplement | Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 6 months |
| 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 | Baseline, 6 months |
| 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 | Baseline, 6 months |
| 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 | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 0 months (baseline), 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Rohloff, MD PhD | Wuqu' Kawoq | Principal Investigator |
| Beth Jimenez, RDN PhD | University of New Mexico | Principal Investigator |
| Andrea Guzman, RDN | Wuqu' Kawoq | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuqu' Kawoq | Tecpán Guatemala | Departamento de Chimaltenango | Guatemala |
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 data will be shared indefinitely on public data repositories at the time of manuscript publication.
Publicly available
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | food groups | Baseline, 6 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Rohloff, Chief Medical Officer | Wuqu' Kawoq | 011-502-4958-1253 | peter@wuqukawoq.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2018 | Jul 14, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Home-based nutrition education | Behavioral | 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 | Behavioral | Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method. |
|
| 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) |
| 0 months (Baseline), 6 months |
| 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) | Baseline, 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 | Baseline, 6 months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | data missing | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Length for age Z score | These are z-scores calculated against the World Health Organization pediatric growth reference population (https://www.who.int/tools/child-growth-standards/standards) | Median | Inter-Quartile Range | Z score |
|
| Weight for age Z score | These are z-scores calculated against the World Health Organization pediatric growth reference population (https://www.who.int/tools/child-growth-standards/standards) | Median | Inter-Quartile Range | Z score |
|
| Weight for length Z score | These are z-scores calculated against the World Health Organization pediatric growth reference population (https://www.who.int/tools/child-growth-standards/standards) | Median | Inter-Quartile Range | Z score |
|
| Minimum acceptable diet | This is a composite diet quality measure developed by the World Health Organization in the technical manual Infant and Young Child Feeding Indicators. It references achieving both minimum recommended food group consumption and solid meal consumption within a 24 hour recall period, with adjustments for age and breastfeeding status. Full details: https://www.who.int/publications/i/item/9789240018389 | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| 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 | Posted | Mean | Standard Deviation | solid meals | Baseline, 6 months |
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months |
|
|
|
| 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 | Posted | Mean | Standard Deviation | food groups | Baseline, 6 months |
|
|
|
| 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) | Posted | Mean | Standard Deviation | change in Z score | 0 months (baseline), 6 months |
|
|
|
| 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) | Posted | Mean | Standard Deviation | Change in Z score | 0 months (Baseline), 6 months |
|
|
|
| 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) | Posted | Mean | Standard Deviation | Change in Z score | Baseline, 6 months |
|
|
|
| Secondary | Mean Change in Household Crop Species From Baseline to 6 Months Diversity Score | Raw count of total crop species cultivated in the home | Posted | Mean | Standard Deviation | crop species | Baseline, 6 months |
|
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|
| 0 |
| 70 |
| 0 |
| 70 |
| 0 |
| 70 |
| EG001 | 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. | 0 | 70 | 0 | 70 | 0 | 70 |
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