NCT02949622

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 31, 2016

Completed
Last Updated

June 21, 2017

Status Verified

June 1, 2017

Enrollment Period

3.6 years

First QC Date

October 14, 2016

Last Update Submit

June 20, 2017

Conditions

Metabolic Syndrome X

Keywords

Metabolic syndromeMediterranean dietStressquality of lifepsychological factors

Outcome Measures

Primary Outcomes (5)

  • Weight

    weight (Kg)

    2 minutes

  • 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

    2 minutes

  • Blood pressure

    Taken according to the recommendations of the American Heart Association, and considering the mean of three readings, each separated by two minutes.

    15 minutes

  • Lipid profile

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

    3 minutes

  • Glycemic profile (fasting glucose)

    glycemic profile (fasting glucose)

    3 minutes

Secondary Outcomes (6)

  • State-Trait Anger Expression Inventory-2 - STAXI-2

    5 minutes

  • Perceived Stress Scale -PSS

    5 minutes

  • Assertiveness Inventory

    5 minutes

  • Medical Outcomes Study 12-Item Short Form - SF-12

    5 minutes

  • Mediterranean-diet scale

    5 minutes

  • +1 more secondary outcomes

Other Outcomes (3)

  • Mini Mental State Examination - MMSE

    5 minutes

  • Mini International Neuropsychiatric Interview - MINI

    30 minutes

  • Height

    2 minutes

Study Arms (2)

Multimodal intervention program

EXPERIMENTAL

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.

Behavioral: Multimodal intervention program

Lifestyle counseling

ACTIVE COMPARATOR

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

Other: Lifestyle counseling

Interventions

Multimodal intervention programBEHAVIORAL

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)

Multimodal intervention program
Lifestyle counselingOTHER

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

Lifestyle counseling

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Osteoarthritis,
  • Active inflammatory diseases,
  • Severe psychiatric disorders and/or significant cognitive impairment assessed using the Mini-Mental State Examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jaqueline Garcia da Silva

Granada, 18009, Spain

Location

Related Publications (1)

  • 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. 2024 Jan-Feb;39(2):195-215. doi: 10.1080/08870446.2022.2055023. Epub 2022 Mar 28.

    PMID: 35345950DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. Student

Study Record Dates

First Submitted

October 14, 2016

First Posted

October 31, 2016

Study Start

February 1, 2013

Primary Completion

September 1, 2016

Study Completion

October 1, 2016

Last Updated

June 21, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)