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Multimodal Intervention Program for Patients With Metabolic Syndrome

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02949622
Acronym
PROMETS
Enrollment
136
Registered
2016-10-31
Start date
2013-02-28
Completion date
2016-10-31
Last updated
2017-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome X

Keywords

Metabolic syndrome, Mediterranean diet, Stress, quality of life, psychological factors

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.

Interventions

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)

OTHERLifestyle counseling

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

Sponsors

University Hospital Virgen de las Nieves
CollaboratorOTHER
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
CollaboratorOTHER_GOV
Universidad de Granada
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Lipid profile3 minuteslipid profile (HDL-C, total cholesterol, triglycerides)
Blood pressure15 minutesTaken according to the recommendations of the American Heart Association, and considering the mean of three readings, each separated by two minutes.
Glycemic profile (fasting glucose)3 minutesglycemic profile (fasting glucose)
Weight2 minutesweight (Kg)
Waist circumference2 minutes(cm). Measured using a tape measure placed in a horizontal plane, located at the midpoint between the last rib and the iliac crest

Secondary

MeasureTime frameDescription
Fagerström Test for Nicotine Dependence5 minutesTo 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.
Mediterranean-diet scale5 minutesTo 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.
State-Trait Anger Expression Inventory-2 - STAXI-25 minutesTo 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 -PSS5 minutesTo measure the perceived stress during the previous month, the Perceived Stress Scale was used, with a total of 14 items.
Assertiveness Inventory5 minutesTo evaluate the general assertiveness, the Assertiveness Inventory (AI) consisting of 30 items was used .
Medical Outcomes Study 12-Item Short Form - SF-125 minutesTo 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.

Other

MeasureTime frameDescription
Mini Mental State Examination - MMSE5 minutesTo assess the initial mental state of the patient and possible cognitive deficits.
Height2 minutesheight (cm)
Mini International Neuropsychiatric Interview - MINI30 minutesBrief diagnostic interview, compatible with the DSM-V and ICD-10 criteria was used to evaluate possible co-morbidities in the sample.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026