Metabolic Syndrome Diagnosis and Treatment for Adults of Low Socioeconomic Status Communities

NCT02459249 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-02-25

No results posted yet for this study

Summary

The objective of this study is to evaluate the effect of a 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.

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 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.

Conditions

Interventions

OTHER

Healthy Lifestyle

A physician and a nutritionist will be give recommendations for diet and exercise emphasizing the importance of a healthy lifestyle (suggesting moderate-intensity activity at least 150 minutes/week and to eat less sodium, fat, sugar, portions and calories). Verbal and written individualized recommendations from trained professionals (nutritionists, and physician) will be provided. Monthly sessions of at least 30 minutes covering diet, exercise, and behavior modifications were held. The first was a one-to-one meeting and was followed by group sessions based on behavioral counseling

OTHER

Placebo Comparator (Treatment of Mexican Health Minister)

General and unspecific recommendations of diet and physical activity for the metabolic syndrome treatment, given for a physician

Sponsors & Collaborators

  • Mexican National Institute of Public Health

    lead OTHER_GOV

Principal Investigators

  • Ismael R Campos, PhD · National Institute of public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-06-30
Completion
2016-07-31

Countries

  • Mexico

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02459249 on ClinicalTrials.gov