Contextualizing Evidence for Action on Diabetes in Low-resource Settings: a Mixed-methods Case Study in Quito and Esmeraldas, Ecuador.
试验速览
- 阶段
- 不适用
- 入组人数
- 1,440
- 试验地点
- 1
- 主要终点
- Glucose Tolerance
研究概览
简要总结
This protocol reflects the first part of a larger mixed-methods study aimed at exploring the process by which global recommendations can be translated into context-specific, evidence-informed action for diabetes prevention in low-resource settings. The CEAD project will be carried out in 2 low-resource settings in Ecuador. Here, in recognition that rigorous epidemiological data on diabetes risk and morbidity is needed to explore applicability of potential actions, the investigators will undertake 2 representative cross-sectional population survey using geospatial sampling. We will collect dat by interview in the homes of the participants using WHO STEPS questionnaires and measure participants' physical and biological parameters.
详细描述
Objective: To provide rigorous epidemiological data on diabetes risk and morbidity in Health District 17D06 in Quito, Ecuador; and Eloy Alfaro District, located in the coastal region of Esmeraldas.
Design: The investigators will undertake two cross-sectional population surveys, with representative samples of the selected health districts, to estimate the prevalence of diabetes, impaired glucose tolerance, and NCD risk factors.
Sample design: Participants will be selected using multi-stage cluster sampling. We will use parishes or 'micro-areas' as primary Enumeration Areas (EA) for which official GIS shape files and population estimates are available. The EAs will be randomly selected with a probability proportional to its population density. In urban areas, after having sampled EAs, buildings or homes will be identified by randomly generated GPS points. The investigators will then sample one person at random in each household.
In rural areas, the investigators will randomly select villages from within the samples EAS, and then undertake the simple random sampling of individuals by using an existing census already developed by voluntary health promotors, and digitised by a local NGO. This census will be updated in the 3 months preceding sample selection to ensure accuracy.
Sample size: The sample size is proposed assuming the prevalence of diabetes is no higher than 10%, to provide an estimate with an absolute precision of +/- 3%, with a 95% confidence level. The investigators assume a design effect of 1.5 (recommended in STEPS guideline for complex designs in absence of locally available alternatives) and will further increased the sample size to allow for up to 20% refusal or loss due to individuals not attending their appointment for physical and biological measurements.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age over 18 years
- •Providing written informed consent
- •Current residence in the study area, defined as at least 20 days of the previous month sleeping in a residence in study zone and no plan to move in the foreseeable future.
排除标准
- •Unability to provide informed consent (e.g. significant mental impairment)
- •Pregnant women and diabetic patients will be excluded from participation on the oral glucose tolerance test.
结局指标
主要结局
Glucose Tolerance
时间窗: Blood sampling 2 hours after drinking a glucose solution of known concentration
New cases of diabetes will be identified by performing the Oral Glucose Tolerance Test. Participants will drink a solution containing 75 g of glucose and their plasma glucose will be measured 2 hours later. Glucose concentration will be given in mg/dl. Individuals will be classified as having impaired glucose tolerance if glycemia after 2 hours is higher than 200 mg/dl and at risk of developing diabetes if he or she has a glicaemia between 140 and 199 mg/dl. Already diagnosed diabetic patients and pregnant women will not undergo this test.
次要结局
- Fasting blood glucose(Venous blood sampling will be the first thing in the morning after at lease 8 hours fasting.)
- Obesity(At the moment of the survey)
- Tobacco consumption(At time of survey, or ever. Frequency for current smokers measured with reference to usual days and weeks.)
- Alcohol consumption(At time of survey, in reference to the previous week, month and over the 12 months prior to survey.)
- Blood pressure(At the moment of the survey)
- Cholesterol(Venous blood sampling will be the first thing in the morning after at least 8 hours fasting.)
- Fruit and vegetable intake(At time of survey in reference to usual days and weeks.)
- Physical activity(At time of survey in reference to usual days and weeks.)
- Waist circumference(At time of survey.)
研究者
Lucy Anne Parker
Lecturer
Universidad Miguel Hernandez de Elche