Multimodal Intervention Program for Patients With Metabolic Syndrome (PROMETS)

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome X
• Intervention / Treatment: Behavioral: Multimodal intervention program; Other: Lifestyle counseling

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18009
    • Jaqueline Garcia da Silva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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)
Active Comparator: Lifestyle counseling; The group of lifestyle counseling will have basic guidelines, according to the recommendations of public health.	Other: Lifestyle counseling; The group of lifestyle counseling will have basic guidelines, according to the recommendations of public health.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini Mental State Examination - MMSE	To assess the initial mental state of the patient and possible cognitive deficits.	5 minutes
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
Height	height (cm)	2 minutes

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.; University Hospital Virgen de las Nieves

Publications and helpful links

General Publications

• Garcia-Silva J, Borrego IRS, Navarrete NN, Peralta-Ramirez MI, Aguila FJ, Caballo VE. Efficacy of cognitive-behavioural therapy for lifestyle modification in metabolic syndrome: a randomised controlled trial with a 18-months follow-up. Psychol Health. 2022 Mar 28:1-21. doi: 10.1080/08870446.2022.2055023. Online ahead of print.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: October 14, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimate): October 31, 2016

Study Record Updates

• Last Update Posted (Actual): June 21, 2017
• Last Update Submitted That Met QC Criteria: June 20, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Metabolic syndrome; Stress; quality of life; Mediterranean diet; psychological factors
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: CAPES 5566-10-0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No