Intensive Intervention to Improve Lifestyles in Subjects With Intermediate Cardiovascular Risk.
NCT03164499, Not applicable, Completed, Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Intensive Intervention to Improve Lifestyles in Subjects With Intermediate Cardiovascular Risk. | ClinicalTrials.gov |
| NCT number | NCT03164499 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 203 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Fundacion para la Investigacion y Formacion en Ciencias de la Salud | ClinicalTrials.gov |
| Conditions | Cardiovascular Risk Factor | ClinicalTrials.gov |
| Interventions | Individual counselling on lifestyles, Additional group counselling on lifestyles | ClinicalTrials.gov |
| First posted | 2017-05-23 | ClinicalTrials.gov |
| Last updated | 2019-04-16 | ClinicalTrials.gov |
Registered outcomes 19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Adherence to the Mediterranean diet | 1 year | Measurement by validated 14-point Mediterranean Diet Adherence Screener | ClinicalTrials.gov |
| Primary | Self-reported physical activity | 1 year | Measurement by short version of the International Physical Activity Questionnaire | ClinicalTrials.gov |
| Secondary | Changes in physical activity | 1 year | Measurement by Pedometer | ClinicalTrials.gov |
| Secondary | Changes in dietary pattern | 1 year | Measurement by semi-quantitative Food Frequency Questionnaire | ClinicalTrials.gov |
| Secondary | Cardiovascular risk factors | 1 year | Measurement by Framingham Risk Score | ClinicalTrials.gov |
| Secondary | Body composition | 1 year | Measurement by Bioelectrical Impedance Analyzer | ClinicalTrials.gov |
| Secondary | Cardio-ankle vascular index (CAVI) | 1 year | Measurement by Vasera® VS-2000 device | ClinicalTrials.gov |
| Secondary | Brachial-ankle pulse wave velocity (ba-PWV) | 1 year | Measurement by Vasera® VS-2000 device | ClinicalTrials.gov |
| Secondary | Ankle-brachial index (ABI) | 1 year | Measurement by Vasera® VS-2000 device | ClinicalTrials.gov |
| Secondary | Health related quality of life | 1 year | Measurement by Spanish version of the SF-12 questionnaire | ClinicalTrials.gov |
| Secondary | Immediate verbal memory | 1 year | Assessment by immediate recall of a list of 15 words, in three attempts | ClinicalTrials.gov |
| Secondary | Delayed verbal memory | 1 year | Assessment by free recall of the words learnt in the first part of the study after a period of approximately 10 minutes | ClinicalTrials.gov |
| Secondary | Phonological fluency | 1 year | Assessment by enumerating for one minute as many words as possible starting with different letters | ClinicalTrials.gov |
| Secondary | Attention | 1 year | Assessment by Trail Making Test A | ClinicalTrials.gov |
| Secondary | Processing speed | 1 year | Assessment by Trail Making Test B | ClinicalTrials.gov |
| Secondary | Executive functions | 1 year | Assessment by Trail Making Test B | ClinicalTrials.gov |
| Secondary | Working memory | 1 year | Assessment by WAIS Digit Span Backward test | ClinicalTrials.gov |
| Secondary | Sustained attention | 1 year | Assessment by Stroop test | ClinicalTrials.gov |
| Secondary | Selective attention | 1 year | Assessment by Stroop test | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)