Metabolic Syndrome Diagnosis and Treatment for Adults of Low Socioeconomic Status Communities
PrEVEnTYCM
Treatment of Metabolic Alterations in Adults Living in Communities With Low Socioeconomic Status
1 other identifier
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Apr 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 6, 2015
CompletedFirst Posted
Study publicly available on registry
June 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedFebruary 25, 2016
February 1, 2016
1.2 years
April 6, 2015
February 23, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
Number of Participants with Metabolic Syndrome
Baseline
Number of Participants with Metabolic Syndrome
3 months
Number of Participants with Metabolic Syndrome
6 months
Number of Participants with Metabolic Syndrome
9 months
Secondary Outcomes (3)
Changes in body weight
3 months
Changes in body weight
6 months
Changes in body weight
9 months
Study Arms (2)
Healthy Lifestyle
EXPERIMENTALA 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
Treatment of Mexican Health Minister
PLACEBO COMPARATORGeneral and unspecific recommendations of diet and physical activity for the metabolic syndrome treatment, given for a physician
Interventions
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
General and unspecific recommendations of diet and physical activity for the metabolic syndrome treatment, given for a physician
Eligibility Criteria
You may qualify if:
- Men and women of 20-55 years old with MS,
- without access to specialized health services,
- residents in rural communities of the state of Morelos-Mexico,
- and without current treatment for MS
You may not qualify if:
- Having bariatric surgery for weight loss,
- current treatment for MS,
- hypothyroidism,
- cancer,
- smoking,
- use of alcohol or drugs,
- psychiatric disorders,
- anti-obesity medication,
- women using birth control methods, pregnant, lactating or near menopause,
- body weight gain or loss greater than two percent two months prior to the start of the study and
- pharmacological treatment for diabetes (or fasting glucose ≥300 mg/dL); hypertension (or ≥150/110 mmHg); or dyslipidaemia (triglycerides ≥400 mg/dL).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute of Public Health
Cuernavaca, Morelos, 62100, Mexico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ismael R Campos, PhD
National Institute of public Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor, researcher
Study Record Dates
First Submitted
April 6, 2015
First Posted
June 2, 2015
Study Start
April 1, 2015
Primary Completion
June 1, 2016
Study Completion
July 1, 2016
Last Updated
February 25, 2016
Record last verified: 2016-02