Treatment of Metabolic Alterations in Adults Living in Communities With Low Socioeconomic Status

The objective of this study is to evaluate the effect of a low-cost healthy-habits intervention tailored to the cultural, economical and social context of the target population in cardiometabolic parameters , for a population with no access to specialized health services. The intervention was designed considering environmental and economic context like availability of food and physical activity spaces; cultural factors like social and culinary traditions; individual food preferences. It encompass a selected set of behavioral and nutritional strategies aiming to achieve control of metabolic disorders involved and to reduce the risk for diabetes.

MATERIAL AND METHODS:

The investigators' study is a nine-month clinical intervention with randomized allocation, and parallel assignment. For the first six months, the participants in the control group will receive the treatment from the primary care service by the Health Minister (Treatment protocols for the components of the metabolic syndrome) as implemented by the local health center, and for the intervention group participants will receive a treatment to improve the quality of the diet and promote the practice of physical activity. Both groups will be reevaluated at third, sixth and ninth-months follow-up. The physician and the nutritionist of the study will be give the recommendations for diet and advice on exercise, mainly by suggesting moderate-intensity activity, such as brisk walks for at least 150 minutes/week.

For the diagnosis of MS, the investigators used the classification from the International Diabetes Federation, and therefore participants were required to have three or more of the following criteria: a) waist circumference ≥ 90 cm in men and ≥ 80 cm in women, b) triglycerides ≥150 mg/dL, c) high density lipoprotein (HDL-cholesterol) < 40 mg/dL in men and < 50 mg/dL in women, d) blood pressure ≥130/85 mmHg; and e) fasting glucose ≥100 mg/dL.

Sample Size. Power size was estimated assuming a 2-sided t-test with an alpha of 0.05 and a power of 80%. Data for the estimation (standard deviation, expected mean difference in indicators) were taken from a previous study on similar population. The investigators expect a difference in prevalence of MS components of at least 10 prevalence points, (-5% control, -10% intervention groups). The sample size was 60 persons per experimental condition (total = 120).