Multimodal Intervention Program for Patients With Metabolic Syndrome

Metabolic Syndrome X Clinical Trial

— PROMETS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02949622
• Other study ID #: CAPES 5566-10-0
• Status: Completed
• Phase: N/A
• First received: October 14, 2016
• Last updated: June 20, 2017
• Start date: February 2013
• Est. completion date: October 2016

Study information

• Verified date: June 2017
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome X
• Syndrome

Intervention

Behavioral:
• 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)

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

Locations

Country	Name	City	State
Spain	Jaqueline Garcia da Silva	Granada

Sponsors (3)

Lead Sponsor	Collaborator
Universidad de Granada	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., University Hospital Virgen de las Nieves

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mini Mental State Examination - MMSE	To assess the initial mental state of the patient and possible cognitive deficits.	5 minutes
Other	Mini International Neuropsychiatric Interview - MINI	Brief diagnostic interview, compatible with the DSM-V and ICD-10 criteria was used to evaluate possible co-morbidities in the sample.	30 minutes
Other	Height	height (cm)	2 minutes
Primary	Weight	weight (Kg)	2 minutes
Primary	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
Primary	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
Primary	Lipid profile	lipid profile (HDL-C, total cholesterol, triglycerides)	3 minutes
Primary	Glycemic profile (fasting glucose)	glycemic profile (fasting glucose)	3 minutes
Secondary	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
Secondary	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
Secondary	Assertiveness Inventory	To evaluate the general assertiveness, the Assertiveness Inventory (AI) consisting of 30 items was used .	5 minutes
Secondary	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
Secondary	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
Secondary	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