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Multimodal Intervention Program for Patients With Metabolic Syndrome (PROMETS)

Primary Purpose

Metabolic Syndrome X

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multimodal intervention program
Lifestyle counseling
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome X focused on measuring Metabolic syndrome, Mediterranean diet, Stress, quality of life, psychological factors

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Jaqueline Garcia da Silva

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Multimodal intervention program

Lifestyle counseling

Arm 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.

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

Outcomes

Primary Outcome Measures

Weight
weight (Kg)
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
Blood pressure
Taken according to the recommendations of the American Heart Association, and considering the mean of three readings, each separated by two minutes.
Lipid profile
lipid profile (HDL-C, total cholesterol, triglycerides)
Glycemic profile (fasting glucose)
glycemic profile (fasting glucose)

Secondary Outcome Measures

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.
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.
Assertiveness Inventory
To evaluate the general assertiveness, the Assertiveness Inventory (AI) consisting of 30 items was used .
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.
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.
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.

Full Information

First Posted
October 14, 2016
Last Updated
June 20, 2017
Sponsor
Universidad de Granada
Collaborators
University Hospital Virgen de las Nieves, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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1. Study Identification

Unique Protocol Identification Number
NCT02949622
Brief Title
Multimodal Intervention Program for Patients With Metabolic Syndrome
Acronym
PROMETS
Official Title
Development and Validation of a Multimodal Intervention Program for Patients With Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
Collaborators
University Hospital Virgen de las Nieves, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X
Keywords
Metabolic syndrome, Mediterranean diet, Stress, quality of life, psychological factors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multimodal intervention program
Arm Type
Experimental
Arm 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.
Arm Title
Lifestyle counseling
Arm Type
Active Comparator
Arm Description
The group of lifestyle counseling will have basic guidelines, according to the recommendations of public health.
Intervention Type
Behavioral
Intervention Name(s)
Multimodal intervention program
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Lifestyle counseling
Intervention Description
The group of lifestyle counseling will have basic guidelines, according to the recommendations of public health.
Primary Outcome Measure Information:
Title
Weight
Description
weight (Kg)
Time Frame
2 minutes
Title
Waist circumference
Description
(cm). Measured using a tape measure placed in a horizontal plane, located at the midpoint between the last rib and the iliac crest
Time Frame
2 minutes
Title
Blood pressure
Description
Taken according to the recommendations of the American Heart Association, and considering the mean of three readings, each separated by two minutes.
Time Frame
15 minutes
Title
Lipid profile
Description
lipid profile (HDL-C, total cholesterol, triglycerides)
Time Frame
3 minutes
Title
Glycemic profile (fasting glucose)
Description
glycemic profile (fasting glucose)
Time Frame
3 minutes
Secondary Outcome Measure Information:
Title
State-Trait Anger Expression Inventory-2 - STAXI-2
Description
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.
Time Frame
5 minutes
Title
Perceived Stress Scale -PSS
Description
To measure the perceived stress during the previous month, the Perceived Stress Scale was used, with a total of 14 items.
Time Frame
5 minutes
Title
Assertiveness Inventory
Description
To evaluate the general assertiveness, the Assertiveness Inventory (AI) consisting of 30 items was used .
Time Frame
5 minutes
Title
Medical Outcomes Study 12-Item Short Form - SF-12
Description
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.
Time Frame
5 minutes
Title
Mediterranean-diet scale
Description
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.
Time Frame
5 minutes
Title
Fagerström Test for Nicotine Dependence
Description
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.
Time Frame
5 minutes
Other Pre-specified Outcome Measures:
Title
Mini Mental State Examination - MMSE
Description
To assess the initial mental state of the patient and possible cognitive deficits.
Time Frame
5 minutes
Title
Mini International Neuropsychiatric Interview - MINI
Description
Brief diagnostic interview, compatible with the DSM-V and ICD-10 criteria was used to evaluate possible co-morbidities in the sample.
Time Frame
30 minutes
Title
Height
Description
height (cm)
Time Frame
2 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Jaqueline Garcia da Silva
City
Granada
ZIP/Postal Code
18009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35345950
Citation
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.
Results Reference
derived

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Multimodal Intervention Program for Patients With Metabolic Syndrome

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