Multimodal Intervention Program for Patients With Metabolic Syndrome

Study Overview
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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.

Official Title
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Development and Validation of a Multimodal Intervention Program for Patients With Metabolic Syndrome

Conditions
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Metabolic Syndrome X

Intervention / Treatment
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* Behavioral: Multimodal intervention program
* Other: Lifestyle counseling


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multimodal intervention program<br>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. | Behavioral: Multimodal intervention program<br>* 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)<br>|
| Active Comparator: Lifestyle counseling<br>The group of lifestyle counseling will have basic guidelines, according to the recommendations of public health. | Other: Lifestyle counseling<br>* The group of lifestyle counseling will have basic guidelines, according to the recommendations of public health.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | weight (Kg) | 2 minutes | 
| Waist circumference | (cm). Measured using a tape measure placed in a horizontal plane, located at the midpoint between the last rib and the iliac crest | 2 minutes | 
| Blood pressure | Taken according to the recommendations of the American Heart Association, and considering the mean of three readings, each separated by two minutes. | 15 minutes | 
| Lipid profile | lipid profile (HDL-C, total cholesterol, triglycerides) | 3 minutes | 
| Glycemic profile (fasting glucose) | glycemic profile (fasting glucose) | 3 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| State-Trait Anger Expression Inventory-2 - STAXI-2 | To determine diverse components of anger, such as experience, expression and control, as well as its facets such as state and trait, the Inventory of Expression of Anger State-Trait (STAXI-2) was used. It consists of 49 items organised in 6 scales and 5 subscales, permitting the attainment of an index for each scale and subscale, as well as a general index of the inventory. | 5 minutes | 
| Perceived Stress Scale -PSS | To measure the perceived stress during the previous month, the Perceived Stress Scale was used, with a total of 14 items. | 5 minutes | 
| Assertiveness Inventory | To evaluate the general assertiveness, the Assertiveness Inventory (AI) consisting of 30 items was used . | 5 minutes | 
| Medical Outcomes Study 12-Item Short Form - SF-12 | To determine the health-related quality of life the Medical Outcomes Study 12-Item Short Form (SF-12), which is composed of two components related to physical and mental health, was used. | 5 minutes | 
| Mediterranean-diet scale | To evaluate the level of adherence to the Mediterranean diet (MedDiet). Consisting of 14 items that evaluate whether foods are included that can prevent cardiovascular risk such as olive oil, fish, vegetables, fruits, cereals and also foods that can increase the chances of risk such as cold meats, trans fats and excess salt. The degree of adherence to the MedDiet is given by the sum of the items. A score below 11 is considered low adherence and higher than 11 as high. | 5 minutes | 
| Fagerström Test for Nicotine Dependence | To evaluate the degree of physical dependence on nicotine. The test consists of six items with two or four response alternatives. The score ranges from 0 to 10. High scores in the FTND (6 or more) indicate a high degree of dependence. | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic syndrome, Mediterranean diet, Stress, quality of life, psychological factors