Cardiovascular Risk Factors And Intensive Dietary Counsel... | NCT02173600

Studies
Cardiovascular Risk Factors And Intensive Dietary Counselling

NCT02173600

Sponsor

Andalusian Regional Ministry of Health

Status

Unknown status

Last Update Posted

Jun 25, 2014Estimated

Enrollment

630Estimated

Phase

Not Applicable

Conditions

High Blood Pressure
Hypercholesterolemia
Tobacco Smoking

Interventions

Group-level Intensive dietary Counselling
Individual-level Intensive Dietary Counselling

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Jun 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Jun 24, 2014

First Submission Date that Met QC Criteria

Jun 24, 2014

First Posted Date

Jun 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2014

Last Update Posted Date

Jun 25, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. María Ángeles Rubín-Gómez, Dr, Andalusian Regional Ministry of HealthPrincipal Investigator

Lead Sponsor

Andalusian Regional Ministry of HealthOTHER_GOV

Collaborators

Name	Class
Andaluz Health Service	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The Intensive Dietary Counselling (IDC) intervention is a prevention and health promotion activity. It is being implemented by the Andalusian Health Service to reinforce basic intervention advice on healthy diet and exercise. The IDC intervention is aimed at the prevention of diseases of the heart and blood vessels (e.g. heart failure, heart attack and stroke).

The main objective of the present study is to assess adherence to the IDC intervention and, consequently, its effectiveness on the prevention of the above mentioned diseases.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

630Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group-level Intensive Dietary Counselling	Experimental	Active learning through 4-6 60-minute sessions workshop, enrolling 8-12 people each time.	Behavioral: Group-level Intensive dietary Counselling
Individual-level Intensive Dietary Counselling	Active Comparator	Individualised dietary counselling delivered at the health-care point	Behavioral: Individual-level Intensive Dietary Counselling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Group-level Intensive dietary Counselling	Behavioral		Group-level Intensive Dietary Counselling
Individual-level Intensive Dietary Counselling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiovascular risk as calculated by means of the SCORE (Systematic Coronary Risk Evaluation) scale. Low-risk regions version.		upt to 12 months from the beginning

Secondary Outcomes

Measure	Description	Time Frame
Health-Related Quality of Life	Spanish version of the EQ-5D-5L questionnaire by the EuroQol Group	Baseline, 6 and 12 months from the beginning

Other Outcomes

Measure	Description	Time Frame
Chronic low-grade inflammation	High sensibility c-reactive protein	Baseline, 6 and 12 months from the beginning

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 40-65 years
Presence of any cardiovascular risk factors (Hypertension, Hypercholesterolemia, tobacco smoking, diabetes, obesity)

Exclusion Criteria:

Currently diagnosed with any vardiovascular disease
Currently involved in any other clinical trial
Cognitive impairment that prevents from providing an informed consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D006937	Hypercholesterolemia
D000073869	Tobacco Smoking
D009043	Motor Activity

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006949	Hyperlipidemias
D050171	Dyslipidemias

Browse Leaves

Not provided

Browse Branches

Not provided