Multimodal Intervention Program for Patients With Metabolic Syndrome

Not Applicable

Completed

• Conditions: Metabolic Syndrome X
• Interventions: Behavioral: Multimodal intervention program; Other: Lifestyle counseling

• Registration Number: NCT02949622
• Lead Sponsor: Universidad de Granada

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2016-09
• Study Completion: 2016-10
• Study First Submitted: 2016-10-14
• Study First Submitted QC: 2016-10-27
• Study First Posted: 2016-10-31
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-20
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multimodal intervention program	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.
Lifestyle counseling	Lifestyle counseling	The group of lifestyle counseling will have basic guidelines, according to the recommendations of public health.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Assertiveness Inventory	5 minutes	To evaluate the general assertiveness, the Assertiveness Inventory (AI) consisting of 30 items was used .
Fagerström Test for Nicotine Dependence	5 minutes	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.
Perceived Stress Scale -PSS	5 minutes	To measure the perceived stress during the previous month, the Perceived Stress Scale was used, with a total of 14 items.
Medical Outcomes Study 12-Item Short Form - SF-12	5 minutes	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.
State-Trait Anger Expression Inventory-2 - STAXI-2	5 minutes	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.
Mediterranean-diet scale	5 minutes	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.

Trial Locations

Locations (1)

Jaqueline Garcia da Silva; 🇪🇸 Granada, Spain