An interventional study of Standard of care nutrition support and Home-based nutrition education in Malnutrition and Dietary Modification, sponsored by Wuqu' Kawoq, Maya Health Alliance. Completed at 1 site in Guatemala. Open to participants aged 6 Months to 24 Months. Per ClinicalTrials.gov, last updated 2021-11-09.
Sponsored by Wuqu' Kawoq, Maya Health Alliance · Not applicable, Interventional, and Treatment
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:
1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.
This study's enrollment of 140 is above the median of 118 across 843 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →Wuqu' Kawoq, Maya Health Alliance is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Behavioral: Home-based nutrition education
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 · Behavioral: Home-based nutrition education · Behavioral: Home-based family gardening
Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)
Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.
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
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
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
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
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
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
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
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
| Milestone | Standard of Care | Home Garden Intervention |
|---|---|---|
| Started | 70 | 70 |
| Completed | 65 | 70 |
| Not completed | 5 | 0 |
Calculated from the World Health Organization Infant and Young Child Feeding Indicators 24 hour diet recall tool
| food groups | Standard of Care | Home Garden Intervention |
|---|---|---|
| Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Child | 0.6 ± 1.84 | 1.29 ± 1.59 |
Calculated from the World Health Organization Infant and Young Child Feeding Indicators 24 hour diet recall tool
| solid meals | Standard of Care | Home Garden Intervention |
|---|---|---|
| Change From Baseline in Mean Number of Solid Meals Consumed Per Day at 6 Months - Child | 0.81 ± 1.61 | 1.11 ± 1.45 |
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
| score on a scale | Standard of Care | Home Garden Intervention |
|---|---|---|
| Change From Baseline in Raw Household Food Insecurity Score at 6 Months | -0.55 ± 1.86 | -0.84 ± 2.1 |
Calculated from the Food and Agriculture Organization's Minimum Dietary Diversity for Women dietary recall
| food groups | Standard of Care | Home Garden Intervention |
|---|---|---|
| Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Female Head of Household | -0.01 ± 1.88 | 0.42 ± 1.75 |
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 Z score | Standard of Care | Home Garden Intervention |
|---|---|---|
| Change in Height/Length for Age Z Score From Baseline to 6 Months | -0.21 ± 0.49 | -0.07 ± 0.51 |
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 Z score | Standard of Care | Home Garden Intervention |
|---|---|---|
| Change in Weight for Age Z Score From Baseline to 6 Months | -0.22 ± 0.39 | -0.12 ± 0.29 |
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 Z score | Standard of Care | Home Garden Intervention |
|---|---|---|
| Change in Weight for Height/Length Z Score From Baseline to 6 Months | -0.38 ± 0.64 | -0.24 ± 0.54 |
Raw count of total crop species cultivated in the home
| crop species | Standard of Care | Home Garden Intervention |
|---|---|---|
| Mean Change in Household Crop Species From Baseline to 6 Months Diversity Score | -1.1 ± 4.15 | 4.62 ± 4.66 |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard of Care | 0/70 (0%) | 0/70 (0%) | 0/70 (0%) |
| Home Garden Intervention | 0/70 (0%) | 0/70 (0%) | 0/70 (0%) |
| Age, Continuous(days) | Standard of Care | Home Garden Intervention | Total |
|---|---|---|---|
| Median | 376 (265 to 524) | 343 (259 to 471) | 353 (262 to 502) |
| Sex: Female, Male(Participants) | Standard of Care | Home Garden Intervention | Total |
|---|---|---|---|
| Female | 32 | 29 | 61 |
| Male | 38 | 41 | 79 |
| Race/Ethnicity, Customized(Participants) | Standard of Care | Home Garden Intervention | Total |
|---|---|---|---|
| Maya ethnicity/language preference | 65 | 68 | 133 |
| Region of Enrollment(participants) | Standard of Care | Home Garden Intervention | Total |
|---|---|---|---|
| Guatemala | 70 | 70 | 140 |
| Length for age Z score(Z score) | Standard of Care | Home Garden Intervention | Total |
|---|---|---|---|
| Median | -3.05 (-3.57 to -2.68) | -3.20 (-3.7 to -2.68) | -3.15 (-3.64 to -2.68) |
| Weight for age Z score(Z score) | Standard of Care | Home Garden Intervention | Total |
|---|---|---|---|
| Median | -1.55 (-2.07 to -1.25) | -1.58 (-2.23 to -1.07) | -1.56 (-2.14 to -1.07) |
| Weight for length Z score(Z score) | Standard of Care | Home Garden Intervention | Total |
|---|---|---|---|
| Median | 0.18 (-0.30 to 0.75) | 0.32 (-0.18 to 0.86) | 0.3 (-0.28 to 0.79) |
| Minimum acceptable diet(Participants) | Standard of Care | Home Garden Intervention | Total |
|---|---|---|---|
| Count of participants | 34 | 48 | 82 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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 information: 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
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Wuqu' Kawoq, Maya Health Alliance