Multimodal Intervention Program for Patients With Metabolic Syndrome (PROMETS)

University of Granada (UGR)

Status: Completed

Conditions: Metabolic Syndrome X

Treatments: Behavioral: Multimodal intervention program; Other: Lifestyle counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT02949622

CAPES 5566-10-0

Details and patient eligibility

About

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.

Enrollment: 136 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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136 participants in 2 patient groups

Multimodal intervention program

Experimental group

Description:

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.

Treatment:

Behavioral: Multimodal intervention program

Lifestyle counseling

Active Comparator group

Description:

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

Treatment:

Other: Lifestyle counseling