NCT01365026

Brief Summary

The potential health gains from healthy lifestyles are very well-known, what is still not known is how to help people to adopt these lifestyles, by means of brief interventions feasible in routine general practice. This study was designed to explore the feasibility and efficacy of innovative implementation strategies for the promotion physical activity, diet and smoking abstinence in primary care. The investigators hypothesize that collegiate planning between practitioners, researchers and managers, with a socio-ecological perspective and taking into account the real context of collaborating centers, will guarantee the sustainability and effectiveness of these programs.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,017

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
4.6 years until next milestone

Study Start

First participant enrolled

January 6, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

2 years

First QC Date

June 1, 2011

Last Update Submit

January 30, 2017

Conditions

Health PromotionHealth EducationPatient EducationCounselingBehavior TherapyHealth Behavior

Keywords

Healthy LifestyleHealth promotionCounsellingAction PlanPrimary Health Care

Outcome Measures

Primary Outcomes (2)

  • Health propmotion clinical practice change

    Rates and proportion of primary care attendees exposed to the 5 A's

    12 months

  • Adoption by primary care attendees of the minimum recommended levels of physical activity, fruits and vegetable consumption and smoking abstinence

    Change in at least one and number of modified lifestyle behaviors

    6 months

Secondary Outcomes (1)

  • Efficiency of healthy lifestyle prescription

    6 months

Study Arms (2)

PVS intervention

EXPERIMENTAL
Behavioral: PVS: Programa de Vida Saludable

Control group

NO INTERVENTION

Interventions

PVS: Programa de Vida SaludableBEHAVIORAL

Lifestyle counseling and prescription

PVS intervention

Eligibility Criteria

Age10 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • primary care attendees not meeting at least one of the healthy lifestyles recommendations
  • to 80 years old

You may not qualify if:

  • psychotic mental disorders
  • brain degenerative disorders
  • mental retardation
  • cognitive impairment
  • dementia
  • end of life

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary Care Research Unit of Bizkaia

Bilbao, E48014, Spain

RECRUITING

Related Publications (10)

  • Sanchez A, Grandes G, Cortada JM, Pombo H, Balague L, Calderon C. Modelling innovative interventions for optimising healthy lifestyle promotion in primary health care: "prescribe Vida Saludable" phase I research protocol. BMC Health Serv Res. 2009 Jun 18;9:103. doi: 10.1186/1472-6963-9-103.

    PMID: 19534832BACKGROUND

  • Grandes G, Sanchez A, Cortada JM, Balague L, Calderon C, Arrazola A, Vergara I, Millan E; Prescribe Vida Saludable group. Is integration of healthy lifestyle promotion into primary care feasible? Discussion and consensus sessions between clinicians and researchers. BMC Health Serv Res. 2008 Oct 14;8:213. doi: 10.1186/1472-6963-8-213.

    PMID: 18854033BACKGROUND

  • Grandes G, Sanchez A, Sanchez-Pinilla RO, Torcal J, Montoya I, Lizarraga K, Serra J; PEPAF Group. Effectiveness of physical activity advice and prescription by physicians in routine primary care: a cluster randomized trial. Arch Intern Med. 2009 Apr 13;169(7):694-701. doi: 10.1001/archinternmed.2009.23.

    PMID: 19364999BACKGROUND

  • Grandes G, Sanchez A, Torcal J, Sanchez-Pinilla RO, Lizarraga K, Serra J; PEPAF Group. Targeting physical activity promotion in general practice: characteristics of inactive patients and willingness to change. BMC Public Health. 2008 May 22;8:172. doi: 10.1186/1471-2458-8-172.

    PMID: 18498623BACKGROUND

  • Zuazagoitia A, Montoya I, Grandes G, Arietaleanizbeascoa MS, Arce V, Martinez V, Sanchez M, Sanchez A. Reliability and validity of the 7-day Physical Activity Recall interview in a Spanish population. Eur J Sport Sci. 2014;14 Suppl 1:S361-8. doi: 10.1080/17461391.2012.705332. Epub 2012 Jul 25.

    PMID: 24444230BACKGROUND

  • Sanchez A, Grandes G, Ortega Sanchez-Pinilla R, Torcal J, Montoya I; PEPAF Group. Predictors of long-term change of a physical activity promotion programme in primary care. BMC Public Health. 2014 Feb 4;14:108. doi: 10.1186/1471-2458-14-108.

    PMID: 24491081BACKGROUND

  • Sanchez A, Bully P, Martinez C, Grandes G. Effectiveness of physical activity promotion interventions in primary care: A review of reviews. Prev Med. 2015 Jul;76 Suppl:S56-67. doi: 10.1016/j.ypmed.2014.09.012. Epub 2014 Sep 26.

    PMID: 25263343BACKGROUND

  • Bully P, Sanchez A, Zabaleta-del-Olmo E, Pombo H, Grandes G. Evidence from interventions based on theoretical models for lifestyle modification (physical activity, diet, alcohol and tobacco use) in primary care settings: A systematic review. Prev Med. 2015 Jul;76 Suppl:S76-93. doi: 10.1016/j.ypmed.2014.12.020. Epub 2015 Jan 5.

    PMID: 25572619BACKGROUND

  • Sanchez A, Silvestre C, Campo N, Grandes G; PreDE research group. Type-2 diabetes primary prevention program implemented in routine primary care: a process evaluation study. Trials. 2016 May 20;17(1):254. doi: 10.1186/s13063-016-1379-0.

    PMID: 27206733BACKGROUND

  • Bully P, Sanchez A, Grandes G, Pombo H, Arietalenizbeaskoa MS, Arce V, Martinez C; PVS Group. Metric properties of the "prescribe healthy life" screening questionnaire to detect healthy behaviors: a cross-sectional pilot study. BMC Public Health. 2016 Dec 7;16(1):1228. doi: 10.1186/s12889-016-3898-8.

    PMID: 27923356BACKGROUND

MeSH Terms

Conditions

Health EducationHealth Behavior

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceBehavior

Study Officials

  • Gonzalo Grandes, MD, MS

    Basque Health Service

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gonzalo Grandes, MD, MS

CONTACT

+34946006637Gonzalo.Grandes@Osakidetza.net

Alvaro sanchez, PhD

CONTACT

+34 946006637alvaro.sanchez@osakidetza.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MS Epidemiology

Study Record Dates

First Submitted

June 1, 2011

First Posted

June 3, 2011

Study Start

January 6, 2016

Primary Completion

December 31, 2017

Study Completion

December 31, 2018

Last Updated

January 31, 2017

Record last verified: 2017-01

Locations

ES(1)