Metabolic Syndrome XPROMETSNCT02949622
Multimodal Intervention Program for Patients With Metabolic Syndrome
A study testing Multimodal intervention program and Lifestyle counseling in people with Metabolic Syndrome X, run by Universidad de Granada at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Metabolic Syndrome X
- What is being tested?
- Multimodal intervention program and Lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2013to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Osteoarthritis,
- Active inflammatory diseases,
- Severe psychiatric disorders and/or significant cognitive impairment assessed using the Mini-Mental State Examination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of a 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.
- Conditions
- Metabolic Syndrome X
- Being tested
- Multimodal intervention program, Lifestyle counseling
- Keywords
- Metabolic syndrome, Mediterranean diet, Stress, quality of life, psychological factors
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal intervention programBehavioural
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 counselingOther
The group of lifestyle counseling will have basic guidelines, according to the recommendations of public health.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Multimodal intervention program |
| Lifestyle counseling | Active comparator | The group of lifestyle counseling will have basic guidelines, according to the recommendations of public health. Receives: Other: Lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
weight (Kg)
Measured: 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
Measured: 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.
Measured: 15 minutes
Lipid profile
lipid profile (HDL-C, total cholesterol, triglycerides)
Measured: 3 minutes
Glycemic profile (fasting glucose)
glycemic profile (fasting glucose)
Measured: 3 minutes
Secondary outcomes (6)
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.
Measured: 5 minutes
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.
Measured: 5 minutes
Assertiveness Inventory
To evaluate the general assertiveness, the Assertiveness Inventory (AI) consisting of 30 items was used .
Measured: 5 minutes
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.
Measured: 5 minutes
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.
Measured: 5 minutes
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startFeb 2013
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome XStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Virgen de las Nieves, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Jaqueline Garcia da Silva, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949622
- Sponsor's protocol ID
- CAPES 5566-10-0
- Acronym
- PROMETS
- Status last verified
- Jun 2017
- First submitted
- 14 Oct 2016
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 35345950
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Multimodal Intervention Program for Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02949622
- Acronym / sponsor ID
- PROMETS / CAPES 5566-10-0
- Conditions
- Metabolic Syndrome X
- Keywords
- Metabolic syndrome, Mediterranean diet, Stress, quality of life, psychological factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- University Hospital Virgen de las Nieves, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Feb 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal intervention program | Experimental | Behavioral: Multimodal intervention programThe 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. |
| Lifestyle counseling | Active comparator | Other: Lifestyle counselingThe group of lifestyle counseling will have basic guidelines, according to the recommendations of public health. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Osteoarthritis,
- Active inflammatory diseases,
- Severe psychiatric disorders and/or significant cognitive impairment assessed using the Mini-Mental State Examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal intervention programThe 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) | Behavioural | Multimodal intervention program |
| Lifestyle counselingThe group of lifestyle counseling will have basic guidelines, according to the recommendations of public health. | Other | Lifestyle counseling |
Primary outcome
Weight
Time frame: 2 minutes
weight (Kg)
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.
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)
6 secondary outcomes
State-Trait Anger Expression Inventory-2 - STAXI-2
Time frame: 5 minutes
Perceived Stress Scale -PSS
Time frame: 5 minutes
Assertiveness Inventory
Time frame: 5 minutes
Medical Outcomes Study 12-Item Short Form - SF-12
Time frame: 5 minutes
Mediterranean-diet scale
Time frame: 5 minutes
Fagerström Test for Nicotine Dependence
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2017.
- Derived from this study: PubMed 35345950Garcia-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal intervention program and Lifestyle counseling in people with Metabolic Syndrome X, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: 2 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02949622, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2017.