Evaluating a Family-based Nutrition and Garden Intervention in Rural Guatemala
Phase: NA
Conditions: Malnutrition, Dietary Modification
Sponsor: Wuqu' Kawoq, Maya Health Alliance

PROTOCOL TITLE: 
Evaluating a family-based nutrition and garden intervention in rural Guatemala 
 
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COVER PAGE: Clinicaltrials.gov results submission 
 
Title: Pilot project: Evaluating a family-based nutrition and garden intervention in rural 
Guatemala 
 
NCT number: 03689504  
 
Version date: December 20, 2018 
 
 

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PROTOCOL TITLE: 
Pilot project: Evaluating a family-based nutrition and garden intervention in rural Guatemala 
 
PRINCIPAL INVESTIGATORS: 
 
Study PI and contact information: 
 
Peter Rohloff, MD, PhD  
Chief Medical Officer, Wuqu’ Kawoq  
617-447-3034  
peter@wuqukawoq.org  
 
Site PI and contact information: 
 
Elizabeth Yakes Jimenez, PhD, RDN, LD (UNM IRB) 
Research Associate Professor, Departments of Pediatrics and Internal Medicine, UNM 
Director, Nutrition Research Network, Academy of Nutrition and Dietetics 
505-688-0718 
eyjimenez@salud.unm.edu  
 
VERSION NUMBER: 2.0 
 
DATE: December 20, 2018 
 
REGULATORY FRAMEWORK: 
Please indicate all that apply: 
☐ 
DOD (Department of Defense) 
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DOE (Department of Energy) 
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DOJ (Department of Justice) 
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ED (Department of Education) 
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EPA (Environmental Protection Agency) 
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FDA (Food and Drug Administration) 
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HHS (Department of Health and Human Services) 
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VA 
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Other: Rotary International      
 
Is this a clinical trial under ICH-GCP E6?   ☐ Yes   X No 

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Evaluating a family-based nutrition and garden intervention in rural Guatemala 
 
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If yes, please confirm that the research team is familiar with and agrees to comply with the 
investigator requirements cited in ICH-GCP E6.  ☐ Yes   ☐ No  
ICH-GCP E6 can be accessed by copying and pasting this URL into your browser: 
http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf 
 
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1. Objectives 
       The specific paaims of this pilot project are:  
1) To evaluate the feasibility of studying whether implementation of family 
gardens paired with a nutrition intervention program in rural Guatemala will lead 
to improvements in maternal and child dietary diversity, child growth and 
household food insecurity compared to a nutrition intervention program alone.  
2) Evaluate the implementation of the intervention through the Reach 
Effectiveness Adoption Implementation Maintenance (RE-AIM) framework. 
We hypothesize that by augmenting a standard nutrition intervention with improved 
household food access through a garden intervention, child growth, dietary diversity and 
food security will improve compared to outcomes with the nutrition intervention alone. 
2. Background 
Children in Guatemala are at high nutritional risk, with a 47% prevalence of stunting 
(chronic malnutrition) and low full coverage with vitamin A supplements (UNICEF 
2016). Only half of Guatemalan children receive a minimum acceptable diet (according 
to World Health Organization criteria measuring dietary diversity and meal frequency) 
from 6-23 months (UNICEF 2016). The indigenous Mayan population is  
disproportionately affected by poverty, food insecurity and malnutrition, with the 
prevalence of chronic malnutrition reaching as high as 70% in rural areas.  
Wuqu’ Kawoq/Maya Health Alliance (MHA) has conducted several studies to determine 
what nutrition interventions really work to prevent and treat chronic malnutrition. As a 
result of these studies, MHA established a home-based nutrition program whose goal is 
catch-up growth, improvement of minimum dietary diversity, minimum meal frequency, 
and minimum acceptable diet and increased caregiver knowledge. In a 50-child pilot, this 
intervention resulted in a mean change in height for age Z score (HAZ) from -3.67 ± 0.99 
to -3.37 ± 0.89 over 6 months and an increase from 15-21% on minimum acceptable diet. 
of families In a subsequent RCT of this intervention, a trend toward improved growth at 6 
months was observed, although the change was not statistically significant. However, 
minimum dietary diversity and minimum acceptable diet both improved significantly 
(risk difference 16.9 and 15.9%, respectively). The intervention also resulted in improved 
daily intake of legumes, eggs, and vitamin A rich fruits and vegetables (risk difference 
16.5, 10.4, 12.7% respectively) (Martinez et al, 2018). 
Agriculture is a major economic activity in Guatemala, with 70% of families working in 
this sector. Family agriculture has many obstacles, including lack of access to land and 
the expansion of cash crop (e.g., sugar cane, African palm) plantations. Most of the food 
that is grown locally is exported, rather than being used for local consumption.  
Public and private organizations in Guatemala have worked to promote the production of 
food for consumption. However, very few of them have measured the impact of 
agricultural initiatives on nutritional status. Moreover, this is the first study in North 
Tecpán to evaluate the potential impact that adding a home food production (for 

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consumption) component to a health-oriented nutrition program can have on maternal 
and child diet quality and nutritional status and household food security. 
3. Study Design 
This is a quasi-experimental study with an intervention group and a nonrandomly selected 
control (standard care) group.  
• The standard-of-care group will consist of subjects recruited from Maya Health 
Alliance’s nutrition program in prioritized communities of North Tecpán, 
Chimaltenango, Guatemala. Subjects in the standard care group will receive the 
current standard child nutrition care (growth monitoring, deworming medication, 
micronutrient supplementation, nutrition education classes and home visits).  
• The intervention group will consist of subjects recruited from MHA’s nutrition 
program in prioritized communities of San Andrés Semetabaj, Sololá, Guatemala. 
Subjects in the intervention group will receive the standard child nutrition care plus 
an additional agriculture component (agriculture education classes, supplies to build a 
home garden near the family home and on-going agricultural support). 
A quasi-experimental design was selected because it was determined that household level 
randomization would be culturally and logistically difficult. 
Both sites are rural. The intervention and control communities are 90 minutes apart by car 
and have similar prevalence of chronic malnutrition in children and similar 
sociodemographic characteristics (education levels, economic activity, health services, 
school access and food access). 
In addition to the primary study endpoints (defined below), we will use the RE-AIM 
framework (Glasglow 1999) to evaluate the implementation of the intervention at the 
caregiver, provider and community levels. Broadly, the five elements of RE-AIM are: reach, 
effectiveness, adoption, implementation and maintenance. For each element, a variety of 
factors affecting implementation will be assessed. A select number of constructs from the 
Consolidated Framework for Implementation Research (CFIR) (Damschroder 2013) will also 
be considered as implementation factors within the RE-AIM framework. Data for this 
implementation analysis will be gathered through program documentation and auditing, 
home visit surveys, focus groups with participants, key informant interviews and semi-
structured community interviews. More details about the RE-AIM framework for this study, 
the implementation factors to be assessed and the instruments for assessing them are outlined 
in Appendix J. 
 
4. Inclusion and Exclusion Criteria 
The study involves enrollment of subjects into an add-on gardening intervention who are 
already participating in an intensive standard-of-care nutrition intervention by MHA staff. 
Therefore, clinical staff (community health workers) at MHA who run that nutrition 
intervention will ascertain initial interest in participation in this study from their clients 
enrolled in the nutrition intervention. Subjects will be approached in their homes to discuss 
potential participation in the study.  
 

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If clients express initial interest, the community health worker will provide that family’s 
contact information to a study nurse, who is trained in human subject’s research ethics and is 
a native speaker of Kaqchikel, the language spoken by the majority of the potential research 
subjects. This nurse will then conduct a home visit to potential subjects to explain the 
proposed research activities in more detail. If the family agrees to participate, then the nurse 
will administer the consent process and enroll them in the study. 
 
Inclusion criteria are: 
• Children who are already scheduled to be enrolled in MHA´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 – 
Households of children with height-for-age Z scores of <= -2.5 will be 
prioritized. 
• At least one caregiver willing to provide written informed consent 
• Caregiver of a child enrolled in the study, including women who may be 
pregnant 
• Planned residence in the study area for the next 18 months 
Exclusion criteria are: 
• 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 MHA/Wuqu’ Kawoq 
staff physician.  
• Caregivers with cognitive impairments that prevent them from being able to 
provide informed consent 
 
Children who are ineligible for enrollment in the research study will receive standard care 
(the home-based nutrition intervention) from MHA. 
        
5. Number of Subjects 
The study will enroll 140 children and their primary caregivers into two study groups: 
standard-of-care (n=70 children and 70 caregivers) and intervention (n=70 children and 
70 caregivers).  
 
6. Study Timelines 
Five to ten families per month will be enrolled into the study from each study 
community. We anticipate that recruitment will take ~7-14 months. 
The research team will have contact with enrolled participants over the course of 18 
months. The primary study data collection time points will be at 0 months (enrollment), 6 
months (end of standard of care/nutrition intervention), 12 months, and 18 months. It is 
anticipated that each of these study data collection visits will last approximately 1 hour, 

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for a total of 4 hours. In addition to that, for the intervention group only, data will be 
collected at the first monthly agricultural home visit and at one additional agricultural 
home visit approximately 4 months thereafter. Each of these agricultural home visits will 
last approximately 1 hour for a total of an additional 2 hours. Combined, the total data 
collection time for the participant in the intervention group will be 6 hours. 
 
The duration of the study interactions with the children and their caregivers is as follows: 
• Standard child nutrition care (received by both groups) will last 6 months and will 
include nutrition classes for 5 weeks and one home visit a month. Standard 
nutrition care will involve approximately 16 hours of contact with MHA clinical 
personnel. 
• The add-on agricultural/garden intervention (received by the intervention group 
only) will last 8 months and will include monthly agricultural classes and monthly 
home visits. The agricultural/garden intervention will involve approximately 16 
hours of contact with MHA agricultural personnel, in addition to the time 
dedicated to the standard nutrition intervention.  
 
A select number of participants (approximately 10) in the intervention group only will be 
asked to participate in one of two focus groups, approximately 90 minutes in length, 
between 6 and 9 months after the first enrollment. Participation in the focus groups will 
be fully voluntary and will not have any impact on the services or benefits received by 
the participants.  
A small number of community leaders and Wuqu’ Kawoq staff will be asked to 
participate in interviews, approximately 90 minutes in length, between 6 and 9 months 
after the first enrollment. Participation in the interviews will be fully voluntary. 
 
The expected total duration of the study is approximately 3 years from the date of IRB 
approval. 
 
 
7. Study Endpoints 
The primary endpoints of this study are changes in the prevalence of: 
• Adequate diet quality, as assessed by the World Health Organization (WHO) 
Infant and Young Child Feeding Indicators (IYCFI) (WHO, 2007) 
minimum dietary diversity, minimum meal frequency, minimum acceptable diet) 
for children and the Minimum Dietary Diversity for Women (MDD-W) indicator 
for caregivers. (FAO 2016) 
• Household food insecurity, as assessed by the Global Food Insecurity Experience 
Scale (household referenced) (FAO 2017) 
Secondary endpoints of the study include changes in: child length-for-age Z-score; child 
weight-for-age Z-score; child weight-for-length Z-score; child prevalence of stunting, 
wasting and underweight; and household total crop species diversity. 

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This study involved no more than minimal risk, so no safety endpoints are specified. 
8. Research Setting 
The study will be conducted in prioritized communities of North Tecpán, Chimaltenango and 
San Andrés Semetabaj, Sololá (see additional details in Section 3. Study Design). These are 
rural Mayan language speaking communities where MHA has been working providing primary 
care and nutrition services for several years. MHA collaborates closely with multiple other 
NGOs as well as Ministry of Health staff in the region.  
All subjects will be recruited via MHAs existing nutrition care program, as described in Section 
4. Inclusion and Exclusion Criteria. All recruitment, enrollment and study-related procedures 
will be conducted in the homes of the subjects. All study procedures will be conducted by MHA 
research staff. The study will be locally overseen and approved by MHA’s IRB. 
 
9. Resources Available 
 
The study will be overseen by:  
 
Elizabeth Yakes Jimenez, PhD, RDN, LD for the University of New Mexico/Academy of 
Nutrition and Dietetics. Elizabeth is a pediatric registered dietitian with a master’s degree in 
public health nutrition and a PhD in epidemiology. She has worked in community and 
clinical settings conducting nutrition research and evaluation projects for approximately 15 
years. She is the Director of Dietetics Practice-Based Research Network (DPBRN) for the 
Academy of Nutrition and Dietetics and a Research Associate Professor in the Departments 
of Pediatrics and Internal Medicine at the University of New Mexico Health Sciences Center.  
Peter Rohloff, MD, PhD for MHA. Peter is the Chief Medical Officer at MHA and an 
Assistant Professor in Medicine at Harvard Medical School. He has 15 years of research 
experience in rural Guatemala, leads a core research team at MHA of 15 staff members, and 
speaks the relevant Mayan languages.  
Research staff at MHA who will participate in the project include Andrea Paola Guzman 
Abril, a Licensed Nutritionist who will serve as the primary research coordinator; and a study 
nurse who will conduct research visits and collect research related data. Two MHA 
community health workers and a MHA agronomist will deliver the study interventions. 
These staff will work full-time on the project, except for the Nutritionist, who will devote 
50% of her time. 
 
Study staff will be employed for the entire timeline of the project, which includes sufficient 
time for data analysis after study completion. All personnel will complete Collaborative 
Institutional Training Initiative’s International Modules (CITI) or the NIH’s Human Subjects 
Training course before doing research in the field. A standard operating procedures manual 
for the study will be developed, and all study staff will receive training on study procedures. 
 
MHA has a dedicated research office located in Tecpán, close to the study communities. The 
office has dedicated file storage cabinets for research documents, high-velocity internet, 
dedicated full-disc encrypted phones and computers, statistical software (STATA), and 

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online HIPAA-compliant file servers and a REDcap server. The study budget includes the 
purchase of a new vehicle for use by the study team. An IT technician and comptroller will 
provide support to the project as needed. 
 
MHA will provide usual care for treatment of severe medical illness identified during the 
screening/recruitment phase. 
 
10. Prior Approvals 
The protocol is approved by the MHA IRB.  
 
11. Multi-Site Research  
 
N/A – this is not a multi-site study 
 
12. Study Procedures  
This study will be conducted in two different sites. These are rural, Mayan language-speaking 
areas where MHA has been working for several years to provide primary care and child nutrition 
services.  
This is a quasi-experimental study with an intervention group and a non-randomly selected 
control (standard-of-care) group.  
The standard-of-care group will consist of subjects recruited from Maya Health Alliance’s 
nutrition program in prioritized communities of North Tecpán, Chimaltenango. 
The standard-of-care child nutrition services include:  
• Intake visit with research nurse to assess basic health history, demographics, WHO IYCFI, 
FIES and MDD-W for women 
• Monthly growth monitoring  
• Monthly micronutrient supplementation  
• Deworming medication (every 6 months)  
• Monthly home visits by community health worker (CHW) to provide individualized growth 
assessment to mothers 
• Nutrition education classes with CHW (nutrition during pregnancy, breastfeeding, 
complementary feeding, chronic and acute malnutrition, hygiene and nutritious recipes)  
The intervention group will consist of subjects recruited from MHA’s nutrition program in 
prioritized communities of San Andrés Semetabaj, Sololá. The intervention group will receive all 
standard-of-care child nutrition services as described above, plus: 
• Agriculture education classes with the study agronomist (home garden package, assessment 
of plant production, weed and pest control, water access, etc.) 
• Home garden supplies including seeds and/or seedlings  
• Monthly home visits from a study agronomist to provide assistance to build a garden near the 
family home and on-going support throughout the study 

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Study data will be independently collected by a study nurse for all enrolled subjects at 0, 6, 12 
and 18 months: 
• Basic health history and demographics Appendix A 
• Child weight and length/height Appendix B 
• Household Quick Poverty Score (QPS) Appendix C 
• Food Insecurity Experience Scale (household) Appendix D 
• WHO Infant and Young Child Feeding indicators (child) Appendix E 
• MDD-W Indicators (caregiver) Appendix F 
• Agriculture Inventory Survey (household) to measure crop diversity and crop utilization 
Appendix G 
Note that child weight and length and WHO IYCFI are already routinely collected as part of 
evaluation data for the standard-of-care nutrition services. 
Additional data will be collected by the study agronomist for the intervention group only during 
the first agricultural home visit and at one additional agricultural home visit approximately 4 
months thereafter: 
• Agricultural Home Visit Baseline Survey (Baseline Agricultural Practices; Gardening 
Experience and Motivation) Appendix H 
• Agricultural Home Visit Follow-up Survey (Adoption of Methods; Level of Home Garden 
Maintenance; Hours Worked in Home Garden) Appendix I 
 
13. Data Analysis 
Descriptive statistics for each group will be calculated using Stata (StataCorp, College Station, 
Texas). Family poverty scores will be calculated with a validated numerical scoring system 
commonly used in Guatemala. Changes in primary and secondary study outcomes will compared 
between study groups using the chi-square test, paired t-tests (or the non-parametric equivalent) 
and linear and logistic regression as appropriate. 
Within the intervention group, the rate of overall adoption will be compared descriptively across 
various demographic groups, and changes in primary and secondary outcomes will also be 
compared descriptively between adopters and non-adopters. Focus groups and interviews will be 
coded and analyzed thematically using select constructs from the Consolidated Framework for 
Implementation Research (CFIR) as a framework. 
This is a pilot study to determine the feasibility of a garden intervention and to generate an initial 
effect size estimate for future, well-controlled studies.  As such no formal power analysis will be 
performed. 
14. Provisions to Monitor the Data to Ensure the Safety of Subjects 
N/A – this study poses no more than minimal risk  
15. Withdrawal of Subjects 
There are no safety/stopping rules, so we do not anticipate any withdrawal from the study unless 
requested by the participant, or in the case that a participant moves out of the study area. 

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Subjects can withdraw from the study at any time that they request. If subjects withdraw from 
the study, we will retain any existing collected data for analysis, as outlined in the consent form, 
unless the subjects specifically request otherwise. 
If subjects wish to withdraw from the nutrition care services or the agricultural intervention, we 
will endeavor to continue data collection at the specified timepoints, if they are agreeable. 
16. Data Management/Confidentiality 
 
Data sharing between the Academy of Nutrition and Dietetics and UNM is covered under 
contract FP5579 (effective date 8/1/2018). Per this agreement, all data shared with UNM for this 
study will be de-identified and transferred using the secure transfer portal provided by UNM 
HSC Central IT. An account will be created for the contact at AND to login to the portal web site 
(https://securetransfer1.health.unm.edu). Data transfer via this link is protected with Secure 
Sockets Layer (SSL) capabilities/128-bit encryption. After the transfer, Elizabeth Jimenez will 
be granted access to the files transferred by the AND contact via the UNM HSC secure network 
storage. 
 
All data transfer from MHA to AND, and from AND to MHA, will also occur using a secure 
transfer portal provided by AND. Data transfer via this portal is protected with Secure Sockets 
Layer (SSL) capabilities/128-bit encryption.   
Research data and unique subject study IDs will be either captured on paper forms or directly 
entered into MHA’s secure Redcap server interface using full-disc encrypted study Android 
phones or laptop computers (demographics, anthropometrics, quick poverty score, WHO IYCF 
indicators, MDD-W, crop diversity survey and the additional agricultural data to be collected by 
the study agronomist) or the Academy of Nutrition and Dietetics Health Informatics 
Infrastructure (ANDHII) database (WHO IYCF indicators, MDD-W). Both databases are 
HIPAA-compliant and secure. Study personnel will each be assigned a unique username and 
password to the Redcap and ANDHII interface. Only PIs or PI´s delegated research coordinator 
will be able to administer user accounts.  
If data is captured on paper forms, it will be stored in a locked filing cabinet in MHA’s central 
office, in a location distinct from consent forms. 
For study data captured on paper forms, double entry in REDCap will be employed. Bimonthly 
data quality checks of paper forms and the study databases will be done by the research study 
coordinator. Native data field definition functions in Redcap and ANDHII will be used to ensure 
data quality at point of entry by research staff. During bimonthly database checks, any issues 
identified will be checked manually against an existing original paper forms if possible.   
Study personnel will be trained to collect anthropometric and dietary diversity data using standard 
methods by a supervising study coordinator. All anthropometric measurements will be completed 
in triplicate during each study visit. Weight will be measured to the nearest 0.1 kg with the use of 
a Seca 310 hanging scale (Seca, Hamburg, Germany), and length/height will be measured to the 
nearest 0.1 cm with the use of a portable length board locally constructed according to UNICEF 
specifications. For data analysis, we will use the mean of the first two readings if they did not 
differ more than a pre-specified tolerance limit (length/height < 0.5 cm, weight < 0.2 kg). If they 
differed more than these pre-specified tolerance limits, the third measurement will be compared 

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with the first and second measurements and the pair of measurements that has the smallest 
difference will be used to calculate the mean. 
On-going quality control via data review and random audits of in-field operations (recruitment, 
anthropometric techniques, dietary diversity, and exit visits) will be performed by the study 
coordinator. The auditor will perform a triplicate of height and weight measurements of the 
children and compare results to the measures obtained by the study nurse, at the same time 
evaluating the measuring technique. The auditor also will perform an independent dietary 
diversity interview with the children's caregiver, and compare results with the data obtained by 
the nurse or CHW. Timely feedback will be provided to the study staff as required. Study staff 
will also participate in monthly anthropometry standardization exercises during which the 
technique, precision, and reliability of their measurements will be evaluated and reinforced. 
At enrollment in the study by the research nurse, each subject will be assigned a unique subject 
study ID number. This number will be registered on the paper consent form (stored in a locked 
file cabinet) and in an electronic study spreadsheet, hosted on MHA’s HIPAA-compliant in-
house file server. This will be the only link between identifiable subject information and their 
research data. Only the PIs or their delegated research coordinator will have access to this 
spreadsheet. Control of access to MHA’s file server will be directly managed by the MHA PI 
(Rohloff) or a delegated research coordinator at MHA.  
Identifiable data (consent forms, master lists linking subjects to study ID, birthdates) will be 
maintained through publication of primary study reports and manuscripts, and for an additional 
period of 5 years. In addition, fully deidentified data sets will be deposited in public data 
repositories at the time of report/manuscript publication. No identifiable data will be released at 
any point. 
17. Data and Specimen Banking 
No specimens will be collected during the study. 
Identifiable data (master lists linking subjects to study ID, birthdates) collected during the study 
will be stored in secure, electronic databases (See Section 16.13). Consent forms will be stored in 
a locked filing cabinet in the MHA office in Guatemala. Identifiable data will be maintained 
through publication of primary study reports and manuscripts, and for an additional period of 5 
years. In addition, fully deidentified data sets will be deposited in public data repositories at the 
time of report/manuscript publication. No identifiable data will be released at any point. 
18. Risks to Subjects 
The study procedures and activities are not more than minimal risk. The child nutrition services 
and many of the data collection procedures are part current standard of care at MHA. We do not, 
therefore, anticipate any adverse outcomes from these procedures and activities. 
It is more likely, however, that a caregiver or community member might erroneously ascribe an 
adverse outcome to the trial. For example, this might occur if a child dies from pneumonia while  
in the trial, even though this would not be expected to be related to the trial itself. We will address 
this issue in the following way: The case would be reported by the study nurse and study 
coordinator to MHA PI Rohloff and MHA’s medical director Dr. Waleska Lopez. Dr. Lopez will 
independently adjudicate the event and make a determination on the need for follow-up care. Dr. 
Rohloff will report the event to MHA’s IRB Chair, Dr. Melvin, for independent review, and will 

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also include the event in a study adverse event log, which will be updated weekly and included in 
each continuing review of the project. 
  
Additionally, we will attempt to minimize conflated adverse outcomes, by excluding all children 
with acute malnutrition or serious medical illness from the trial as outlined in Section 4. Inclusion 
and Exclusion Criteria. Any child with acute malnutrition or serious medical illness will be 
immediately referred to the MHA clinical team and will receive comprehensive clinical care. 
  
Another potential risk from the study is that it might cause conflict between the study 
communities. This could occur because caregivers receiving the nutrition intervention might 
learn that others are also receiving the additional garden component. We attempt to minimize 
this risk by recruiting the intervention families from a different community than we recruit the 
standard-of-care families. 
  
Finally, there is the potential of accidental disclosure of protected health information. Please see 
Section 16. Data Management/Confidentiality for procedures to minimize this risk.  
 
19. Potential Benefits to Subjects 
 
Individuals in both groups may benefit directly. Both groups will receive micronutrient 
supplementation, deworming medication, home visits and nutrition education, which we 
anticipate will have positive outcomes on diet quality, catch-up growth, decreased rates of severe 
stunting, and promotion of cognitive and motor development. 
The agriculture intervention group will receive supplies to build a garden, home visits and 
agricultural education. We anticipate that this will increase their knowledge as well as food 
availability for their family, even after the study has finished (as the families will keep their 
garden supplies).  
Over the long term, reversing the ill effects of stunting and food insecurity also contributes to 
improved school performance, adult earning potential, and reduced incidence of adult non-
communicable diseases. 
This study will help to fill an identified gap in research at the nexus of nutrition, food production 
and health. Specifically, this work will provide evidence about measurement and indicators used 
to evaluate diet quality, health impacts and food security when providing nutrition interventions 
paired with agriculture interventions in rural communities in the highlands of Guatemala. 
 
The implementation evaluation component of this study will provide new knowledge about how 
various caregiver, provider and community-level factors can affect the implementation of a home 
gardens program for malnutrition, giving valuable insights into how and why the intervention 
achieved the level of success that it did. 
  
In this way, the study will be help create a functional integrated nutrition and agriculture model 
that can be used by other organizations who are working or want to work in the treatment and 
prevention of malnutrition, while offering an understanding of the implementation challenges that 

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they would be likely to confront in the process. Thus, the benefits could conceivably multiply to 
many more children and their families in Guatemala than simply the study families. 
 
20. Recruitment Methods 
 
Potential subjects will already be planning to participate in MHA’s individualized nutrition 
services in communities surrounding Tecpán, Guatemala (see Section 4. Inclusion and 
Exclusion Criteria). 
 
Subjects (primary caregivers of children participating in the nutrition services) will be 
approached in their homes during a regular home visit by the community health worker, who will 
provide initial information about the study. If the subject expresses interest, then the community 
health worker will provide that person’s information to a study nurse, who is trained in human 
subject’s research protocols and a native speaker of Kaqchikel, the language spoken by most of 
the potential research subjects. This nurse will then conduct a home visit to potential subjects to 
explain the proposed research activities in more detail.  
 
If more than one child in the home is already enrolled in the MHA nutrition intervention, then 
only the youngest of those children in the eligible age range will be enrolled in this study. 
 
21. Provisions to Protect the Privacy Interests of Subjects 
Subjects will be approached at a time that is most convenient to them, in their homes.  We have 
learned from our previous work in these communities that the best times to conduct home visits 
are from 8:30 to 11:30 AM or from 2:00 to 4:00 PM. 
Study personnel will introduce themselves and ask permission to enter a home before discussing 
the study, obtaining consent, conducting any surveys or taking anthropometric measurements. 
Study personnel will be natively fluent in Spanish and the locally spoken language, or use an 
interpreter, to ensure comprehension for participants. 
Study personnel will not participate in the nutrition services, and therefore will not have access to 
MHA electronic medical record data. 
 
22. Economic Burden to Subjects 
 
Research Procedures 
Number of 
Samples/Procedures 
Responsible Party 
 
 
Study 
3rd Party 
Payer or 
Participant 
Quick poverty score     
 4     
X 
☐ 
  Agriculture Inventory Survey 
 4     
X 
☐ 

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Agriculture Home Visit Survey 
  2     
X 
☐ 
Focus Groups (Select Participants Only) 
 1    
X  
☐ 
 Interviews (Select Leaders and WK Staff)  
 1     
X  
☐ 
      
☐ 
☐ 
      
☐ 
☐ 
Standard of Care Procedures 
Number of 
Samples/Procedures 
Responsible Party 
 
 
Study 
3rd Party 
Payer or 
Participant 
Basic health history and demographics 
  1    
X 
☐ 
Child weight and length/height 
  4    
X 
☐ 
WHO IYCF indicators 
  4    
X 
☐ 
MDD-W indicator 
  4    
X 
☐ 
Food Insecurity Experience Scale     
  4    
X 
☐ 
 
      
☐ 
☐ 
      
      
☐ 
☐ 
      
      
☐ 
☐ 
 
There will be no direct costs to subjects for participation in the study. All services provided by 
MHA are given for free, including the standard of care nutrition and agricultural services that are 
under study in this protocol. Educational and intervention components will be conducted either in 
the subjects’ home or in a nearby community facility and, therefore, no travel costs will be 
incurred.   
 
23. Compensation 
Subjects will not receive any monetary compensation for participation.  
 
24. Compensation for Research-Related Injury 
N/A - This research does not involve more than minimal risk to subjects. 
25. Consent Process 
Consent will be obtained by the study nurse, who is trained in human subject’s research ethics 
and a native speaker of Kaqchikel, the language spoken by most of the potential research 
subjects  If the potential participant agrees to take part in the study, the nurse will explain the 
consent process, obtain at least one caregiver’s signature (or equivalent, see below for more 
explanation), and will enroll them in the study. The consent process will take place in 
participant’s homes. 
Subjects will not be required to provide immediate consent upon hearing about the study. The 
study nurse will be instructed to provide each subject with a waiting period of up to 14 days if 
requested before obtaining consent. 
A small number of program participants, community leaders and Wuqu’ Kawoq staff will be 
approached to participate in focus groups and community interviews, respectively, once the 

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study is already underway. For these groups, a verbal consent script will be read to the 
participants (Appendix C) allowing them to either accept or decline to participate. 
Written consent will be obtained using the attached consent form (Appendix A). Consent will be 
obtained by a trained study nurse who has completed relevant human subjects ethics training and 
who is fluent in Spanish and Kaqchikel. Many of the anticipated participants will not be literate, 
and so the consent form will, in most cases, be read out loud to them by the study staff. A “teach 
back” process will be used to assess participant understanding of the consent form content.  
If participants are unable to sign their name, the study nurse administering consent will sign the 
form documenting that consent was administered and note that the participant is unable to sign 
his/her name. This process will be witnessed and attested by a independent member of the study 
team. The potential participant will not be required to sign with an “X” or to place a thumbprint 
given the political context of this region of Guatemala. During the civil war, individuals who 
were not literate could be made to sign documents as an oppressive strategy for extracting land 
titles. Hence, this study will not perpetuate those practices.  
The consent form and process will make it clear that consent to participate in the research will 
not in any way impact the quality or quantity of clinical services, including ongoing MHA 
primary care and nutrition services.  
An attempt will be made to obtain consent from both guardians of the child. However, consent 
from one parent/guardian will be sufficient for enrollment in the trial, as this study involves no 
more than minimal risk. Children in the study are aged 6-24 months; therefore, they are not 
capable of providing assent. 
Informed consent documents will be in Spanish. This is because Mayan languages are largely 
oral languages, and no subjects in the target area can reasonably be expected to read them. 
Similarly, very few professionals, such as the available pool of study staff, can read them. We 
will conduct extensive practice sessions with the nurse leading informed consent to ensure that 
her ongoing oral script accurately represents the Spanish written text, in the (highly likely) case 
of many caregivers being unable to read the text. 
 
26. Documentation of Consent 
Written informed consent will be obtained by a research study nurse. For more details on the  
consent process see Section 20. Recruitment Methods and Section 25. Consent Process. 
Briefly, subjects will be approached in their home and informed consent will be obtained at 
that time.  
Many of the anticipated participants will not be literate, and so the consent form will, in most 
cases, be read out loud to them by the study staff. If participants are unable to sign their name, 
the study nurse administering consent will sign the form documenting that consent was 
administered and note that the participant is unable to sign his/her name. This process will be 
witnessed and attested by a independent member of the study team. The potential participant 
will not be required to sign with an “X” or to place a thumbprint given the political context of 
this region of Guatemala. During the civil war, individuals who were not literate could be made 
to sign documents as an oppressive strategy for extracting land titles. Hence, this study will not 
perpetuate those practices.  

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27. Study Test Results/Incidental Findings 
 
Community health workers typically verbally share child growth results and progress and 
provide feedback on dietary diversity with caregivers as part of standard-of-care/child nutrition 
services; this will continue during the study. 
 
Any incidental findings noted during the course of the study will be evaluated by MHA primary 
care medical team.  
 
28. Sharing Study Progress or Results with Subjects 
Local meetings will be held every 6-months to update each community about the study and 
progress. Additionally, the final study findings (in aggregate) will be shared with each 
community. 
 
29. Inclusion of Vulnerable Populations 
The population is highly vulnerable to coercion because of the potential for perceiving 
participation in the study to be a prerequisite to receiving services from MHA. The informed 
consent document and process will explain clearly that all families will receive the standard of 
care nutrition services and primary care services, whether they participate in the study or not. 
There will be complete separation between nutrition services and agricultural intervention staff 
(community health workers, agronomist) and study research nurses. This is important, so the 
standard nutrition services can be delivered regardless of subjects’ participation in the study. 
No monetary compensation will be provided for research participation, to avoid coercive economic 
influence to participate. 
Also, the majority of subjects will be Kaqchikel speakers with limited Spanish fluency.  The study 
staff will be native speakers of to mitigate any language barriers. Teach back methods will be used 
to assess comprehension during the consent process.  
Pregnant caregivers may participate in the study. The Pregnant Women Checklist has been 
completed below. Children 6-24 months will participate in the study. The Children Checklist has 
been completed below. 
30. Community-Based Participatory Research 
N/A- this study is not designed as CBPR. Clinical and programmatic leadership at MHA have 
close working relationships with local community authorities in all study communities. 
Local community authorities have been apprised of the planned work.  
31. Research Involving American Indian/Native Populations 
 
N/A This study does not involve American Indian/Native populations. 
 
32. Transnational Research 
 

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Note that this project was developed by the Guatemala team, and will be reviewed and locally 
overseen by the MHA IRB. The Dietetics Practice-Based Research Network (Elizabeth Jimenez) 
will collaborating with the study team to provide technical assistance related to study design and 
implementation and data analysis and interpretation. 
 
This study will be conducted in prioritized communities of San Andrés Semetabaj, Sololá and 
North Tecpán, Chimaltenango. These sites were selected because they are currently being served 
by MHA’s primary care and nutrition services. MHA has been working in this area for several 
years, with a focus on providing culturally and linguistically appropriate care to the Mayan 
indigenous population. MHA has conducted several community-based research studies in the 
area, and their experience informed the development of this protocol. One significant difference 
with U.S. culture, noted in Section 25. Consent Process, is that there is historical trauma 
associated with asking non-literate individuals to sign with an “X” or thumbprint. We have taken 
this into account when designing the consent process.  
 
Elizabeth Jimenez has extensive experience with conducting cross-cultural research, with 
previous experience collaborating with teams from Southeast Asia and East and West Africa. 
She is proficient in Spanish. The research team from Guatemala has extensive experience 
working in the study area (providing medical care and conducting research) and are fluent in 
Spanish (spoken and written) and Kaqchikel (spoken – primarily an oral language). All research 
team members from Guatemala involved in consent and research procedures will complete 
human research ethics training.   
The consent process has been described above in Section 25. Consent Process and Section 26. 
Documentation of Consent.  
 
Clinical and programmatic leadership at MHA have close working relationships with local 
community authorities in all study communities. Local community authorities have been 
apprised of the planned work. Local meetings will be held every 6-months to update each 
community about the study and progress. Additionally, the final study findings (in aggregate) 
will be shared with each community. 
 
33. Drugs or Devices 
N/A This research does not involve any drugs or devices. 
 
 

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Checklist Section 
This section contains checklists to provide information on a variety of topics that require special 
determinations by the IRB.  Please complete all checklists relevant to your research. 
 
I. Waivers or Alterations of Consent, Assent, and HIPAA Authorization 
A. Waiver of Documentation of Consent 
Complete this checklist if you intend to obtain consent verbally but will not be 
obtaining signatures from subjects on a consent form to document consent.  Waivers 
of documentation of consent are commonly requested when using scripts, information 
sheets, or email or survey introductions to present the elements of consent instead of 
using a traditional consent form. 
1. Are you requesting a waiver of documentation of consent for some or all 
subjects? 
 All 
X Some. Explain: If participants are unable to sign their name, the study nurse 
administering consent will sign the form documenting that consent was 
administered and note that the participant is unable to sign his/her name. The 
potential participant will not be required to sign with an “X” or to place a 
thumbprint given the political context of this region of Guatemala. During the 
civil war, individuals who were not literate could be made to sign documents 
as an oppressive strategy for extracting land titles. Hence, this study will not 
perpetuate those practices.  
Verbal consent will be obtained for focus groups.  
2. Provide justification for one of the following: 
a) That the only record linking the subject and the research would be the 
consent document and the principal risk would be potential harm 
resulting from a breach of confidentiality. Each subject will be asked 
whether the subject wants documentation linking the subject with the 
research, and the subject's wishes will govern. 
      
b) That the research presents no more than minimal risk of harm to 
subjects and involves no procedures for which written consent is 
normally required outside of the research context. 
This research presents no more than minimal risk of harm to the 
subjects. Most of the study activities and procedures are part of the 

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standard-of-care nutrition services delivered by MHA, and the other 
activities and procedures are low risk (surveys and focus groups with 
adults and agricultural education) and do not require written consent 
outside the research context.  
3. Do you intend to provide subjects with a written statement regarding the 
research in lieu of a traditional consent form? 
 Yes. Please attach a copy to your submission in Click. 
X No 
 
 
II. Vulnerable Populations 
  
A. Children 
Complete this checklist if the subject population will include children. 
1. Select the category of research that you believe this research falls within and 
provide justification for any associated criteria.  If there are different 
assessments for different groups of children or arms (e.g., placebo vs. drug), 
include a memo to provide an assessment for each group.   
X Research not involving greater than minimal risk. (Minimal risk means 
that the probability and magnitude of harm or discomfort anticipated 
in the research are not greater in and of themselves than those 
ordinarily encountered in daily life or during the performance of 
routine physical or psychological examinations or tests.) 
☐ Research involving greater than minimal risk but presenting the 
prospect of direct benefit to the individual subjects. 
Provide justification for each of the following criteria: 
(1) The risk is justified by the anticipated benefit to the subjects: 
      
(2) The relation of the anticipated benefit to the risk is at least as 
favorable to the subjects as that presented by available 
alternative approaches: 
      

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☐ Research involving greater than minimal risk and no prospect of direct 
benefit to individual subjects, but likely to yield generalizable 
knowledge about the subject's disorder or condition. 
Provide justification for each of the following criteria: 
(1) The risk represents a minor increase over minimal risk: 
      
(2) The intervention or procedure presents experiences to subjects 
that are reasonably commensurate with those inherent in their 
actual or expected medical, dental, psychological, social, or 
educational situations: 
      
(3) The intervention or procedure is likely to yield generalizable 
knowledge about the subjects' disorder or condition which is of 
vital importance for the understanding or amelioration of the 
subjects' disorder or condition 
      
B. Pregnant Women and Fetuses 
Complete this checklist if the subject population will include pregnant women and 
fetuses. 
X This checklist does not need to be completed if the research is both minimal risk 
and is not conducted, funded, or otherwise subject to regulation by DHHS, DOD, 
EPA, or VA. 
Provide justification for each of the following: 
1. Where scientifically appropriate, preclinical studies, including studies on 
pregnant animals, and clinical studies, including studies on non-pregnant 
women, have been conducted and provide data for assessing potential risks to 
pregnant women and fetuses. 
      
2. The risk to the fetus is caused solely by interventions or procedures that hold 
out the prospect of direct benefit for the woman or the fetus; or, if there is no 
such prospect of benefit, the risk to the fetus is not greater than minimal and 
the purpose of the research is the development of important biomedical 
knowledge which cannot be obtained by any other means. 
      
3. Any risk is the least possible for achieving the objectives of the research.