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Completed

NCT Number: NCT02949622

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.

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Key information

Conditions

Metabolic Syndrome X Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jaqueline Garcia da Silva

Granada, 18009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multimodal intervention program

Behavioral

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)

Lifestyle counseling

Other

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

Primary outcomes

  1. Weight

    Time frame: 2 minutes

    weight (Kg)

  2. 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

  3. 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.

  4. Lipid profile

    Time frame: 3 minutes

    lipid profile (HDL-C, total cholesterol, triglycerides)

  5. Glycemic profile (fasting glucose)

    Time frame: 3 minutes

    glycemic profile (fasting glucose)

Secondary outcomes

  1. State-Trait Anger Expression Inventory-2 - STAXI-2

    Time frame: 5 minutes

    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.

  2. Perceived Stress Scale -PSS

    Time frame: 5 minutes

    To measure the perceived stress during the previous month, the Perceived Stress Scale was used, with a total of 14 items.

  3. Assertiveness Inventory

    Time frame: 5 minutes

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

  4. Medical Outcomes Study 12-Item Short Form - SF-12

    Time frame: 5 minutes

    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. Mediterranean-diet scale

    Time frame: 5 minutes

    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.

  6. Fagerström Test for Nicotine Dependence

    Time frame: 5 minutes

    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.

Other outcomes

  1. Mini Mental State Examination - MMSE

    Time frame: 5 minutes

    To assess the initial mental state of the patient and possible cognitive deficits.

  2. Mini International Neuropsychiatric Interview - MINI

    Time frame: 30 minutes

    Brief diagnostic interview, compatible with the DSM-V and ICD-10 criteria was used to evaluate possible co-morbidities in the sample.

  3. Height

    Time frame: 2 minutes

    height (cm)

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • University Hospital Virgen de las Nieves

Registry information

Official study title

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

Acronym: PROMETS

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 31, 2016
Registry last updated
Jun 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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