Global Health Centers of Excellence (GHCoE) Guatemala
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Clinical Trial/Epidemiology Study
Open BioLINCC Study See bottom of this webpage for request information
December 2010 - May 2014 (Protocol 1)
June 2010 - August 2010 (Protocol 2: Phase 1)
August 2010 - December 2010 (Protocol 2: Phase 2)
March 2011 - October 2011 (Protocol 2: Phase 3)
May 2011 - January 2014 (Protocol 3)
May 2011 - February 2014 (Protocol 4)
January 29, 2018
Clinical Trial URLs
Primary Publication URLs
Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
Specific Consent Restrictions
Dietary Factors Associated with Cardiovascular Disease Risk in School-age Children and their Parents in Mesoamerica
Phase 1: Cardiovascular disease risk factors in school-age children living in poor urban areas of Guatemala
Phase 2: Obesity and cardiovascular disease risk factors in school-age children living in poor urban areas of Guatemala
Phase 3: Feasibility of a community-based pilot intervention to prevent chronic cardio metabolic diseases in school-age children
Primary health and community-based support model to lower the risk of cardiovascular diseases in individuals with type 2 diabetes mellitus and/or arterial hypertension, in urban areas of San Jose, Costa Rica and Tuxtla Gutierrez, Chiapas.
Use of mobile technology to prevent progression of pre-hypertension in Latin American urban settings
To determine the prevalence of dietary risk factors for cardiovascular disease (CVD) in children and adults of Mesoamerica.
Phase 1: To explore the common knowledge and attitudes about childhood environmental determinants of cardiovascular health among school-age children and their parents from urban settings in Guatemala.
Phase 2: To quantify the occurrence of CVD risk factors in normal weight and overweight school-age children in Guatemala.
Phase 3: To assess the feasibility and acceptability of a community-based intervention aimed to promote healthy lifestyles to reduce risk factors for chronic cardiometabolic diseases in children.
To adapt and validate an intervention model for CVD prevention in patients with diabetes and high blood pressure for implementation in primary health care centers of the region.
To evaluate the effectiveness of using mobile health technology to promote lifestyle modification focused on reducing blood pressure and preventing progression from pre-hypertensive status to hypertension in individuals at poor urban clinics in Argentina, Guatemala, and Peru.
Cardiovascular diseases (CVD) present a significant and growing public health burden, particularly in developing countries, and are the leading cause of death in adults in Mesoamerica. Risk can be significantly reduced through the modification of lifestyle, diet, and physical activity.
In the Mesoamerican region, diet factors associated with CVD risk include deficiency in alpha-linolenic acid, low consumption of legumes, increased use of palm oil in cooking, increased intake of refined grains and cereals, and deficiency in omega-3 fatty acids. In addition, obesity rates for both children and adults continue to rise. This study sought to establish a reference point for the prevalence of CVD diet related risk factors in Mesoamerican countries in order to facilitate interventions that improve diet quality and increase physical activity.
Encouraging a healthy lifestyle at an early age before food and lifestyle preferences are solidified is critical to CVD prevention, especially in urban and impoverished communities which suffer from nutritional disparities. However, data regarding physical activity patterns and other risk factors in children are limited, and most school- and home-based interventions have failed to prevent childhood obesity. Therefore, this study sought to develop and test a socio-ecologic intervention model for the improvement of diet and physical activity patterns in elementary school-age children from urban settings in Guatemala as a tool for CVD prevention in a manner appropriate to the population’s specific needs and culture. This was established in three phases: (1) collection of baseline and formative research data for such a model, (2) collection of information on the status of CVD risk factors and how premature the damage is established, and (3) development of a community-based intervention that is feasible, culturally acceptable and effective in promoting healthy behaviors in school-age children.
CVD prevention is especially important in patients with type 2 diabetes mellitus and/or high blood pressure. Adherence to treatment and lifestyle changes can reduce CVD risk. This study focused on intervention at the primary healthcare center and community level using a CVD risk prevention model originally developed in Guatemala.
Pre-hypertensive individuals are at high risk of progression to hypertension and developing CVD. Early interventions to increase the practice of healthy lifestyles in these high-risk individuals could reduce blood pressure, decrease the rate of progression to hypertension, or prevent hypertension entirely. However, primary care systems in developing countries often lack comprehensive prevention, screening, and management programs directed to pre-hypertensive individuals.
The use of mobile technologies is emerging as a useful tool for the healthcare system in the developing world given the limitations in the workforce, financial resources, high burden of disease paired with high population group, and difficult to reach populations. Developed countries have used mobile health to promote weight loss, physical activity, and smoking cessation. Therefore, this protocol sought to examine the effectiveness of mobile health contact in Latin America.
Eligible participants included children aged 7 to 12 and their parents. The study sought to recruit at least 30 families from each of 9 Mesoamerican countries: Mexico, Guatemala, Belize, Honduras, El Salvador, Nicaragua, Costa Rica, Panama, and the Dominican Republic. About 20 children were randomly selected from each of four peri-urban schools in the capital of each country. Children were then excluded from the study if they did not live with both parents, were pregnant or had a pregnant mother, or had a sibling already included in the study.
Phase 1: The target population consisted of children 9 to 12 years of age enrolled in low-income urban elementary schools from three urban municipalities around Guatemala City (Villa Nueva, Santa Catarina Pinula, and Mixco). About 50 children and their parents were to be randomly selected from four public and two private schools for focus group discussions. Home visits were further performed for up to 30 families (5 per school) of focus group participants.
Phase 2: The target population consisted of children 6 to 12 years of age enrolled in five low-income urban elementary schools from the communities of San Jose La Comunidad and Municipality of Mixco in the Guatemala City area. The study aimed to enroll 96 healthy children, with 48 being of normal weight (BMI z score < +1) and 48 being overweight (BMI z score > +1). Exclusion criteria included chronic illness, menarche, siblings already in the study, and being underweight.
Phase 3: The target population consisted of children 9 to 12 years of age enrolled in two low-income urban public schools located within the Municipality of Mixco, and their mothers. All students in the grade and their parents were exposed to the intervention, but only a randomly selected sample of 120 child/mother pairs (60 per school) were evaluated at the beginning and at the end of the intervention. Exclusion criteria included children with long-term restrictions for physical activities, siblings already in the study, and a child with a pregnant mother.
Eligible participants in the intervention component of the study were over 21 years of age, residents of the selected healthcare community, literate, and diagnosed with type 2 diabetes mellitus or hypertension. Exclusion criteria included diabetes complications, history of stroke or heart attack, mental disorders preventing understanding of instructions, or any impairment preventing regular physical activity. Patients could be recruited at the health center, at health promotion community activities, or self-referred via informational campaigns. The study aimed to enroll 90 patients in the control group and 90 patients in the intervention group.
40 participants 30 to 60 years of age were enrolled at health centers in Guatemala City for SMS messages validation. The intervention included men and women 30 to 60 years of age that were pre-hypertensive, not currently on blood pressure medication, and that owned a cellular phone. Individuals with a previous diagnosis or treatment of hypertension or diabetes, a medical history of cardiovascular disease, or who were illiterate were excluded. 8 men and 8 women were selected for the pilot testing. 212 participants were to be enrolled for the main intervention.
The study scheduled home visits for participating families where researchers administered questionnaires, obtained anthropometric and blood pressure measurements, and collected biological specimens. Questionnaires included socio-demographic information, food security characteristics, health conditions, physical activity, and a semi-quantitative food frequency questionnaire. At the visit, participants were provided with a pedometer to be worn for seven days in order to assess physical activity patterns. Based on the food frequency questionnaire, researchers analyzed frequent food brands for sodium and trans-fatty acid content.
The primary risk factors of interest included high consumption of grains and refined cereals, high consumption of trans fats and sodium, excessive television and electronic game use, being overweight or obese, hypertension, hyperglycemia, high fasting glucose levels, high plasma homocysteine, high C-reactive protein levels, and metabolic syndrome.
Phase 1: Researchers conducted direct observations at schools, home visits, and focus groups with children and their parents. In the schools, researchers observed the classroom, physical education, recess, extracurricular activities, school surroundings, and the community in general. Focus groups were held at the school and were scheduled to last up to 2 hours. Participants were asked about their knowledge, attitude and practice related to health, obesity, diet, physical activity, and tobacco use; identification of individual and environmental factors that promote or discourage a healthy diet and physical activity; existing infrastructure at schools, homes, and neighborhoods that could help or hinder the implementation of the intervention; perception on changes in the school, home and neighborhood environments that could promote a healthy diet and physical activity; and gender and ethnic aspects related to diet and physical activity. For families selected for a home visit, researchers collected information on the household physical environment, socio-economic status, and family lifestyle and practices. Researchers also requested to take pictures of the kitchen space, food storage room, dining and family room.
Phase 2: Participating children attended a clinical visit during which a fasting blood draw was collected for the measurement of cardiometabolic factors. In addition, arterial stiffness and pulse-wave velocity were measured via a SphyygmoCor device that used 3-lead ECG and transcutaneous tonometry. Physical fitness was assessed by measuring peak oxygen uptake during an incremental treadmill exercise protocol to exhaustion and through a 6-minute walk test. A food frequency questionnaire and qualitative questionnaire about physical activity, health, and socio-demographics were used to assess behavioral factors and socio-economic status. Body composition was assessed using the 4-compartment model measurements of body fat, bone mass, and total body water. Total energy expenditure was assessed using a heart rate monitoring technique to compare heart rate and oxygen uptake during rest and during exercise, both for 15 minutes. Participants were additionally provided with an actigraph in order to measure the amount and intensity of activity every 15 seconds through accelerometry, a pedometer to count steps and their intensity, and a heart rate monitor to measure heart rate every 60 seconds. The actigraph and pedometer were to be worn at the waist for seven days during waking hours. The heart rate monitor was to be worn continuously for three days.
Phase 3: The study used an intervention called ¡Pilas!, which included strategies meant to accomplish the following goals: increase fruit and vegetable intake; decrease intake of sugar-sweetened beverages and increase water intake; decrease consumption of high-fat, high-sodium, and high-sugar foods; increase the amount of time spent in moderate-to-vigorous physical activity; decrease the amount of time spent watching television and playing electronic games; decrease exposure to secondhand smoke; and prevent initiation of tobacco use and alcohol consumption. The design of this intervention was developed within the context of a socio-ecological multilevel model.
Participating teachers, food kiosk staff, child health promoters, and religious leaders were required to engage in a five hour ¡Pilas! training workshop held at each school. The study also coordinated with the Open School Program (OSP), which offered free artistic, community, cultural, and sports workshops to children and adults on the weekend; the Municipality of Mixco, which organized activities that promote healthy lifestyles among Mixco residents; and the Health Center of Mixco, which initiated the Child Health Promoters Program at one of the selected schools to train children in health issues, human rights, public safety, and natural disasters. A community meeting was held at months three, five, and seven of the study to allow participants to share their opinions, experiences, advances, difficulties and solutions about the intervention program.
Mothers and children were individually evaluated at the school during three different days. Assessments included family characteristics, anthropometry, dietary intake, and psychosocial factors. Physical activity was measured by a pedometer worn for seven days and by observing the student during physical education classes and recess.
The ¡Pilas! pilot program was implemented for five months. Participating teachers engaged students in ten activities in two 45 minute sessions per month. Each activity included homework intended to promote family interaction. In addition, the schools implemented a set of physical education norms to promote moderate-to-vigorous physical activity, as well as a five episode radio mini-series that was played during parent’s meetings to enhance parental support of behavioral change. Healthy recipe booklets were provided to vendors in order to limit or eliminate unhealthy foods and beverages. Additionally, participating community members and institutions communicated and reinforced messages of a healthy lifestyle to children, and/or offered opportunities and safe places to families for practicing a healthy diet and recreational activities.
The study was conducted in four stages. Stage 1 was scheduled to last for three months and involved formative research centered on identifying the capacity, resources and programs offered by the national, state and local health system regarding CVD care, including type 2 diabetes mellitus and high blood pressure. In addition, the study gathered data regarding knowledge, perceptions, and opinions of healthcare providers and community members regarding CVD. This was done through structured interviews with key health system officials in each country, and focus groups with healthcare providers and people affected by diabetes and/or hypertension.
Stage 2 was scheduled to last for four months and involved adaptation and validation of healthcare protocols and educational material in order to incorporate the proposed model and ensure that the materials were culturally relevant. This included two consensus-building workshops per country with health center staff that were intended to introduce and discuss criteria for diagnosis, risk detection and clinical management of diabetic and/or hypertensive patients. Educational materials were composed based on the handbook “Corazón sano y feliz” (Healthy and Happy Heart), developed from an NHLBI program to train cardiovascular health promoters in Latin communities of the United States. Two focus groups in each country were held with community members and healthcare workers in order to validate the material.
Stage 3 involved the actual application of the proposed model for 10 months in order to assess its feasibility, acceptability and short-term effectiveness. Each healthcare center in Tuxtla Gutiérrez, Chiapas and San José, Costa Rica was assigned an intervention and control community. Healthcare center patients in the control communities were evaluated without any specific intervention and received standard treatment. Health center staff were trained using the validated materials to better identify, evaluate, and provide treatment to patients with diabetes or hypertension. At least three health workers in each center were additionally trained as community promoters.
The first visit for eligible participants included assessment of waist circumference, blood glucose, blood pressure, and smoking and medical history. 10 year CVD risk was calculated through an algorithm developed by the WHO for Latin American countries. Treatment included a combination of recommendations about healthy lifestyles including smoking cessation, a healthy diet, and regular physical activity; and pharmacological therapy where appropriate including metformin for diabetic patients and thiazide diuretics for hypertensive patients. Healthcare staff also recommended that patients attend educational sessions by health promoters every two weeks. All patients were scheduled for at least two follow-up visits, with the frequency of the visits dependent on the patient’s CVD risk.
Stage 4 was scheduled to last for 10 months and involved qualitative research on family and gender dynamics to define possible adaptations to the proposed model and expand its scope. Men in particular had a low participation rate in educational sessions, therefore researchers conducted 8 to 10 in-depth interviews with men that did not participate to understand their reasons for doing so and solicit recommendations for reaching other men. Men that did participate in activities were also interviewed to understand factors that enabled participation. The study additionally recruited families of those treated at a healthcare center, and performed one or two home visits to conduct in-depth interviews and characterize relationships in the family. Finally, researchers conducted interviews with healthcare workers to understand their ideas about feasible ways to reach relatives and men.
The study held four focus group discussions with community members and two with health staff for the purposes of collecting data for the development of educational messages and a counseling tool. SMS messages that promoted lifestyle modification focused on reducing blood pressure were developed from existing educational materials available in the participating countries and then assessed through a series of individual interviews with community members for content, clarity and acceptability.
Participants in the pilot test received an initial 30-minute phone call from trained staff regarding the following interventions: sodium intake, fruits and vegetable intake, fat and sugar intake and physical activity. After the call, participants received four weekly text messages, and then participated in a short telephone interview to explore the comprehension and acceptance of the information.
The main intervention was conducted at health centers in poor urban areas. Pre-hypertensive patients at the clinic were referred to the study. During the initial assessment, anthropometric measurements were taken, and participants completed a questionnaire to assess dietary patterns, physical activity, and inactivity behaviors, stress, and smoking and drinking habits. Participants were then randomly assigned to the control or experimental group. During visits at baseline, 6 months, 12 months, and 6 months post-intervention, measurements included blood pressure, weight, height, abdominal circumference, use of medication and behavioral risk factors. After the baseline assessment, participants in both groups received lifestyle modification counseling through a 30 minute talk given by trained staff and reinforced by printed educational materials. Participants in the intervention group additionally received monthly one-to-one phone calls by trained professionals regarding healthy lifestyles focused on reducing blood pressure. The calls included a questionnaire to explore the behavior change stage of the participant regarding the topic to be discussed. Callers promoted behavior change through algorithms based on the Transtheoretical Model and the Health Belief Model, which are psychosocial theories of behavior change, and Motivational Interviewing, a non-judgmental, guided, empathetic style of counseling. After each call, participants received a weekly text message to reinforce the counseling.
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Resources AvailableStudy Datasets Only
- Data Dictionary ra01 (PDF - 322.8 KB)
- Data Dictionary ra02 (PDF - 1020.3 KB)
- Data Dictionary ra03 (PDF - 104.0 KB)
- Data Dictionary ra04 (PDF - 1.3 MB)
- RA01 Forms (PDF - 501.2 KB)
- RA01 Protocol (PDF - 1.1 MB)
- RA02 Forms (PDF - 1.2 MB)
- RA02 Protocol (PDF - 741.9 KB)
- RA03 Forms (PDF - 513.7 KB)
- RA03 Protocol (PDF - 898.4 KB)
- RA04 Forms (PDF - 1.1 MB)
- RA04 Protocol (PDF - 684.2 KB)
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