MalnutritionNCT03689504
Evaluating a Family-based Nutrition and Garden Intervention in Rural Guatemala
A study testing Home-based nutrition education and Home-based family gardening in people with Malnutrition and Dietary Modification, run by Wuqu' Kawoq, Maya Health Alliance at 1 site in Guatemala.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 24 months
- Conditions the study is for
- Malnutrition, Dietary Modification
- What is being tested?
- Home-based nutrition education and Home-based family gardening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteGuatemala
- Study dates
- 20 Jan 2018to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
- Evaluate the impact of the garden intervention on maternal and child dietary diversity, child growth and household food insecurity.
- Use the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework to conduct a preliminary implementation analysis, to guide a future, well-controlled study.
- Conditions
- Malnutrition, Dietary Modification
- Being tested
- Standard of care nutrition support, Home-based nutrition education, Home-based family gardening
- Keywords
- Guatemala, indigenous, dietary diversity, chronic malnutrition, Maya, agriculture, behavior change, food insecurity
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care nutrition supportDietary supplement
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 educationBehavioural
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 gardeningBehavioural
Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Standard of care nutrition support; Behavioral: Home-based nutrition education |
| 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) Receives: Dietary Supplement: Standard of care nutrition support; Behavioral: Home-based nutrition education; Behavioral: Home-based family gardening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 6 months
Secondary outcomes (4)
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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start20 Jan 2018
- Primary completion11 May 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuqu' Kawoq, Maya Health Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- Academy of Nutrition and Dietetics
- Responsible party
- Sponsor
- Investigators
- Peter Rohloff, MD PhD, Principal investigator, Wuqu' KawoqBeth Jimenez, RDN PhD, Principal investigator, University of New MexicoAndrea Guzman, RDN, Study director, Wuqu' Kawoq
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689504
- Sponsor's protocol ID
- WK-2018-002
- Status last verified
- Oct 2021
- First submitted
- 26 Sep 2018
- Last updated
- 9 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Family-based Nutrition and Garden Intervention in Rural Guatemala
- ClinicalTrials.gov ID
- NCT03689504
- Acronym / sponsor ID
- WK-2018-002
- Conditions
- Malnutrition, Dietary Modification
- Keywords
- Guatemala, indigenous, dietary diversity, chronic malnutrition, Maya, agriculture, behavior change, food insecurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Wuqu' Kawoq, Maya Health AllianceUniversity, hospital or other
- Collaborators
- Academy of Nutrition and Dietetics
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 11 May 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 28 Sep 2018 (actual)
- Results
- Posted 9 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Evaluate the impact of the garden intervention on maternal and child dietary diversity, child growth and household food insecurity.
- Use the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework to conduct a preliminary implementation analysis, to guide a future, well-controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Dietary Supplement: Standard of care nutrition support, Behavioral: Home-based nutrition educationThe 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 | Dietary Supplement: Standard of care nutrition support, Behavioral: Home-based nutrition education, Behavioral: Home-based family gardeningThis arm adds an 8 month individualized home-based family garden intervention to the existing standard of care (home-based nutrition education) |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care nutrition supportSubjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter) | Dietary supplement | Home Garden Intervention, Standard of Care |
| Home-based nutrition educationHealth promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents. | Behavioural | Home Garden Intervention, Standard of Care |
| Home-based family gardeningHealth promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method. | Behavioural | Home Garden Intervention |
Primary outcome
Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Child
Time frame: 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
Time frame: 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
Time frame: 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
Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Female Head of Household
Time frame: Baseline, 6 months
Calculated from the Food and Agriculture Organization's Minimum Dietary Diversity for Women dietary recall
4 secondary outcomes
Change in Height/Length for Age Z Score From Baseline to 6 Months
Time frame: 0 months (baseline), 6 months
Change in Weight for Age Z Score From Baseline to 6 Months
Time frame: 0 months (Baseline), 6 months
Change in Weight for Height/Length Z Score From Baseline to 6 Months
Time frame: Baseline, 6 months
Mean Change in Household Crop Species From Baseline to 6 Months Diversity Score
Time frame: Baseline, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Rohloff, MD PhD principal investigator
Wuqu' Kawoq
Beth Jimenez, RDN PhD principal investigator
University of New Mexico
Andrea Guzman, RDN study director
Wuqu' Kawoq
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based nutrition education and Home-based family gardening in people with Malnutrition and Dietary Modification, run by Wuqu' Kawoq, Maya Health Alliance at 1 site in Guatemala.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guatemala. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Mean Number of Food Groups Consumed Per Day at 6 Months - Child (time frame: Baseline, 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.