Multimodal Intervention Program for Patients With Metabolic Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-10-31

Brief Summary

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The aim of this study is to identify the psychological, emotional and lifestyle variables that can have an influence on the different components of metabolic syndrome (MetS) and develop a program for change lifestyle in this patients.

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Detailed Description

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Conditions

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Metabolic Syndrome X

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Multimodal intervention program

The intervention program will be in group format, with a size of 10 to 12 patients per group and with an extension of 12 sessions. The treatment program will feature sessions with psychoeducation of metabolic syndrome and treatment model, problem solving, stress management, anger management, social skills, self-efficacy and social support.

Group Type EXPERIMENTAL

Multimodal intervention program

Intervention Type BEHAVIORAL

The intervention is structured as follows:

Review of previous session (20 min) Agenda and goals (5 min) Presentation of the topic to be worked (15 min) Training (60 min) Summary and feedback (15 min)

Lifestyle counseling

The group of lifestyle counseling will have basic guidelines, according to the recommendations of public health.

Group Type ACTIVE_COMPARATOR

Lifestyle counseling

Intervention Type OTHER

The group of lifestyle counseling will have basic guidelines, according to the recommendations of public health.

Interventions

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Multimodal intervention program

The intervention is structured as follows:

Review of previous session (20 min) Agenda and goals (5 min) Presentation of the topic to be worked (15 min) Training (60 min) Summary and feedback (15 min)

Intervention Type BEHAVIORAL

Lifestyle counseling

The group of lifestyle counseling will have basic guidelines, according to the recommendations of public health.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Between 25 and 65 years age
* Waist circumference \>88 cm for women and \>102 cm for men
* Blood pressure: systolic ≥ 130 mmHg and diastolic ≥ 85 mmHg
* Fasting glucose level ≥ 110mg/dL
* Triglycerides: ≥ 150 mg/dL
* HDL cholesterol ≤40 mg/dL in men and ≤50 mg/DL in women

Exclusion Criteria

* Osteoarthritis,
* Active inflammatory diseases,
* Severe psychiatric disorders and/or significant cognitive impairment assessed using the Mini-Mental State Examination.

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No