Development and Validation of a Multimodal Intervention Program for Patients With Metabolic Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad de Granada
- Enrollment
- 136
- Locations
- 1
- Primary Endpoint
- Waist circumference
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 25 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Lifestyle counseling
The group of lifestyle counseling will have basic guidelines, according to the recommendations of public health.
Intervention: Lifestyle counseling (Other)
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.
Intervention: Multimodal intervention program (Behavioral)
Outcomes
Primary Outcomes
Waist circumference
Time Frame: 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
Time Frame: 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
Time Frame: 2 minutes
weight (Kg)
Lipid profile
Time Frame: 3 minutes
lipid profile (HDL-C, total cholesterol, triglycerides)
Glycemic profile (fasting glucose)
Time Frame: 3 minutes
glycemic profile (fasting glucose)
Secondary Outcomes
- Assertiveness Inventory(5 minutes)
- Fagerström Test for Nicotine Dependence(5 minutes)
- Perceived Stress Scale -PSS(5 minutes)
- Medical Outcomes Study 12-Item Short Form - SF-12(5 minutes)
- State-Trait Anger Expression Inventory-2 - STAXI-2(5 minutes)
- Mediterranean-diet scale(5 minutes)
Investigators
Jaqueline Garcia da Silva
Ph.D. Student
Universidad de Granada