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Completed

NCT Number: NCT03164499

Intensive Intervention to Improve Lifestyles in Subjects With Intermediate Cardiovascular Risk.

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.

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Key information

Conditions

Cardiovascular Risk Factor Adherence Interventions Behavior Cardiovascular Diseases Health Behavior Health Education Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

35 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Primary Care Research Unit, The Alamedilla Health Center

Salamanca, Castilla and Leon, 37003, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Individual counselling on lifestyles

Behavioral

Individual standardized counselling on healthy diet, daily physical activity, stress management, smoking cessation, and moderation in alcohol consumption.

Additional group counselling on lifestyles

Behavioral

Group sessions focusing on cardiovascular risk, diet and moderation in alcohol consumption, physical activity and stress management, and smoking cessation will be held in health centres for four consecutive weeks. Each session will last 60-90 minutes, and will be led by two trained nurse practitioners. Ten participants will assist each group. During each session, attendance will be recorded and printed educational materials related to the topic addressed will be distributed.

Follow-up calls to reinforce lifestyle modification and record the barriers to behaviour change found will be performed 6 and 9 months after enrolment.

Primary outcomes

  1. Adherence to the Mediterranean diet

    Time frame: 1 year

    Measurement by validated 14-point Mediterranean Diet Adherence Screener

  2. Self-reported physical activity

    Time frame: 1 year

    Measurement by short version of the International Physical Activity Questionnaire

Secondary outcomes

  1. Changes in physical activity

    Time frame: 1 year

    Measurement by Pedometer

  2. Changes in dietary pattern

    Time frame: 1 year

    Measurement by semi-quantitative Food Frequency Questionnaire

  3. Cardiovascular risk factors

    Time frame: 1 year

    Measurement by Framingham Risk Score

  4. Body composition

    Time frame: 1 year

    Measurement by Bioelectrical Impedance Analyzer

  5. Cardio-ankle vascular index (CAVI)

    Time frame: 1 year

    Measurement by Vasera® VS-2000 device

  6. Brachial-ankle pulse wave velocity (ba-PWV)

    Time frame: 1 year

    Measurement by Vasera® VS-2000 device

  7. Ankle-brachial index (ABI)

    Time frame: 1 year

    Measurement by Vasera® VS-2000 device

  8. Health related quality of life

    Time frame: 1 year

    Measurement by Spanish version of the SF-12 questionnaire

  9. Immediate verbal memory

    Time frame: 1 year

    Assessment by immediate recall of a list of 15 words, in three attempts

  10. Delayed verbal memory

    Time frame: 1 year

    Assessment by free recall of the words learnt in the first part of the study after a period of approximately 10 minutes

  11. Phonological fluency

    Time frame: 1 year

    Assessment by enumerating for one minute as many words as possible starting with different letters

  12. Attention

    Time frame: 1 year

    Assessment by Trail Making Test A

  13. Processing speed

    Time frame: 1 year

    Assessment by Trail Making Test B

  14. Executive functions

    Time frame: 1 year

    Assessment by Trail Making Test B

  15. Working memory

    Time frame: 1 year

    Assessment by WAIS Digit Span Backward test

  16. Sustained attention

    Time frame: 1 year

    Assessment by Stroop test

  17. Selective attention

    Time frame: 1 year

    Assessment by Stroop test

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Other

Collaborators

  • Instituto de Investigación Biomédica de Salamanca

Registry information

Official study title

Effectiveness of an Intensive Intervention to Improve Lifestyles in Subjects With Intermediate Cardiovascular Risk: a Randomized Controlled Trial.

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
May 23, 2017
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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