Clinical trial NCT03164499: Intensive Intervention to Improve Lifestyles in Subjects With Intermediate Cardiovascular Risk.
Official title: Effectiveness of an Intensive Intervention to Improve Lifestyles in Subjects With Intermediate Cardiovascular Risk: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Keywords: Health education
Life style
Risk factors
Cardiovascular diseases
Cognitive performance
Quality of life
Lead sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Sponsor class: OTHER
Collaborators: name: Instituto de Investigación Biomédica de Salamanca
First posted: 2017-05-23
Enrollment: 203
Sex: ALL
Minimum age (years): 35
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized controlled trial aimed to design an intensive intervention to modify lifestyles of subjects with intermediate cardiovascular risk and evaluate its effectiveness. 200 participants aged 35-74 years who have intermediate cardiovascular risk will be included. Subjects will be selected by consecutive sampling at urban primary care health centers from Salamanca (Spain) and they will be randomized to a control or an intervention group. Both groups will receive individual standardized counselling on healthy diet, daily physical activity, smoking cessation, and moderation in alcohol consumption. Moreover, individuals from the intervention group will receive additional group counselling and follow-up calls. The effect of the intervention will be assessed using lifestyles and quality of life questionnaires, metabolic control parameters, inflammation markers, anthropometric and vascular function measurements, and neuropsychological tests.


Eligibility criteria: Inclusion Criteria:

* Adults aged 35-74 years who had an intermediate cardiovascular risk defined according to the Framingham risk equation will be included.

Exclusion Criteria:

* Personal history of atherosclerotic disease.
* Unable to do exercise or follow the Mediterranean diet.
* Institutionalized.
* Terminal illness.
* Mental disorders that limited the intervention compliance.

Primary outcomes:
measure: Adherence to the Mediterranean diet
timeFrame: 1 year
measure: Self-reported physical activity
timeFrame: 1 year
Secondary outcomes:
measure: Changes in physical activity
timeFrame: 1 year
measure: Changes in dietary pattern
timeFrame: 1 year
measure: Cardiovascular risk factors
timeFrame: 1 year
measure: Body composition
timeFrame: 1 year
measure: Cardio-ankle vascular index (CAVI)
timeFrame: 1 year
measure: Brachial-ankle pulse wave velocity (ba-PWV)
timeFrame: 1 year
measure: Ankle-brachial index (ABI)
timeFrame: 1 year
measure: Health related quality of life
timeFrame: 1 year
measure: Immediate verbal memory
timeFrame: 1 year
measure: Delayed verbal memory
timeFrame: 1 year
measure: Phonological fluency
timeFrame: 1 year
measure: Attention
timeFrame: 1 year
measure: Processing speed
timeFrame: 1 year
measure: Executive functions
timeFrame: 1 year
measure: Working memory
timeFrame: 1 year
measure: Sustained attention
timeFrame: 1 year
measure: Selective attention
timeFrame: 1 year
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Primary Care Research Unit, The Alamedilla Health Center
state: Castilla And Leon
Study officials:
affiliation: Primary Care Research Unit, The Alamedilla Health Center
name: Sara Mora Simón, PhD
role: PRINCIPAL_INVESTIGATOR
References: