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

12. april 2019 opdateret af: Fundacion para la Investigacion y Formacion en Ciencias de la Salud

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

203

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
    • Castilla And Leon
      • Salamanca, Castilla And Leon, Spanien, 37003
        • Primary Care Research Unit, The Alamedilla Health Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

35 år til 74 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Control group
Individual counselling on lifestyles.
Adfærdsmæssigt: Individual counselling on lifestyles
Individual standardized counselling on healthy diet, daily physical activity, stress management, smoking cessation, and moderation in alcohol consumption.
Eksperimentel: Intervention group
Individual counselling on lifestyles and additional group counselling on lifestyles.
Adfærdsmæssigt: Individual counselling on lifestyles
Individual standardized counselling on healthy diet, daily physical activity, stress management, smoking cessation, and moderation in alcohol consumption.
Adfærdsmæssigt: Additional group counselling on lifestyles

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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adherence to the Mediterranean diet
Tidsramme: 1 year
Measurement by validated 14-point Mediterranean Diet Adherence Screener
1 year
Self-reported physical activity
Tidsramme: 1 year
Measurement by short version of the International Physical Activity Questionnaire
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in physical activity
Tidsramme: 1 year
Measurement by Pedometer
1 year
Changes in dietary pattern
Tidsramme: 1 year
Measurement by semi-quantitative Food Frequency Questionnaire
1 year
Cardiovascular risk factors
Tidsramme: 1 year
Measurement by Framingham Risk Score
1 year
Body composition
Tidsramme: 1 year
Measurement by Bioelectrical Impedance Analyzer
1 year
Cardio-ankle vascular index (CAVI)
Tidsramme: 1 year
Measurement by Vasera® VS-2000 device
1 year
Brachial-ankle pulse wave velocity (ba-PWV)
Tidsramme: 1 year
Measurement by Vasera® VS-2000 device
1 year
Ankle-brachial index (ABI)
Tidsramme: 1 year
Measurement by Vasera® VS-2000 device
1 year
Health related quality of life
Tidsramme: 1 year
Measurement by Spanish version of the SF-12 questionnaire
1 year
Immediate verbal memory
Tidsramme: 1 year
Assessment by immediate recall of a list of 15 words, in three attempts
1 year
Delayed verbal memory
Tidsramme: 1 year
Assessment by free recall of the words learnt in the first part of the study after a period of approximately 10 minutes
1 year
Phonological fluency
Tidsramme: 1 year
Assessment by enumerating for one minute as many words as possible starting with different letters
1 year
Attention
Tidsramme: 1 year
Assessment by Trail Making Test A
1 year
Processing speed
Tidsramme: 1 year
Assessment by Trail Making Test B
1 year
Executive functions
Tidsramme: 1 year
Assessment by Trail Making Test B
1 year
Working memory
Tidsramme: 1 year
Assessment by WAIS Digit Span Backward test
1 year
Sustained attention
Tidsramme: 1 year
Assessment by Stroop test
1 year
Selective attention
Tidsramme: 1 year
Assessment by Stroop test
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Samarbejdspartnere

Instituto de Investigación Biomédica de Salamanca

Efterforskere

  • Ledende efterforsker: Sara Mora Simón, PhD, Primary Care Research Unit, The Alamedilla Health Center

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2017

Primær færdiggørelse (Faktiske)

31. december 2018

Studieafslutning (Faktiske)

31. marts 2019

Datoer for studieregistrering

Først indsendt

22. maj 2017

Først indsendt, der opfyldte QC-kriterier

22. maj 2017

Først opslået (Faktiske)

23. maj 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. april 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. april 2019

Sidst verificeret

1. april 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • BIO 16/00006

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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