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PVS: Innovative Programs For Healthy Lifestyle Promotion in Primary Care: 'Prescribe Healthy Life'

This study is currently recruiting participants.

Verified September 2012 by Basque Health Service

Sponsor:

Information provided by (Responsible Party):

Gonzalo Grandes, Basque Health Service

ClinicalTrials.gov Identifier:

NCT01365026

First received: June 1, 2011

Last updated: September 10, 2012

Last verified: September 2012

History of Changes

Purpose

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 potential efficacy of innovative programs 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.

Condition	Intervention	Phase
Health Promotion Health Education Patient Education Counseling Behavior Therapy Health Behavior	Behavioral: PVS: Programa de Vida Saludable	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Feasibility and Potential Effectiveness of Innovative Programs for Health Promotion in Primary Care: The 'Prescribe Healthy Life' Project (PVS)

Resource links provided by NLM:

MedlinePlus related topics: Healthy Living Smoking Smoking and Youth

U.S. FDA Resources

Further study details as provided by Basque Health Service:

Primary Outcome Measures:

adoption of the minimum recommended levels of physical activity, fruits and vegetables consumption and smoking abstinence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change in at least one and number of modified lifestyle behaviors

Secondary Outcome Measures:

Perceived preventive practice [ Time Frame: 12 months ] [ Designated as safety issue: No ]
self reported change in preventive practices delivered by primary care professionals

Estimated Enrollment:	1366
Study Start Date:	June 2011
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PVS intervention	Behavioral: PVS: Programa de Vida Saludable Lifestyle counseling and prescription
No Intervention: Control group

Detailed Description:

BACKGROUND: Primary health care (PHC) services provide special opportunities for healthy lifestyles promotion. Yet, despite its potential impact health promotion is not widespread and the results obtained are limited.

OBJECTIVE: To explore the feasibility and potential efficacy of a program for the promotion physical activity, diet and smoking abstinence in PHC, innovative for its collegiate planning between practitioners, researchers and managers, with a socio-ecological perspective and taking into account the real context of collaborating centers.

DESIGN AND LOCATION: quasi-experimental clinical trial in Phase II, conducted in 8 PHC centers (4 intervention and 4 control), with the collaboration of the majority of primary care professionals within each center, and the participation of 1366 participants randomly selected from the target population. INTERVENTION CENTRES: Each of the intervention centers will pilot during 1 year an intervention program to manage the multiple lifestyle behaviors (sedentary lifestyle, unhealthy diet, and smoking), consisting of multiple active ingredients based on main theoretical models of behavior change and fundamentally, in the 5As strategy (Ask, Advise, Agree, Assist and Arrange follow-up), and modeled by professionals in each intervention center, according to their priority needs, and including community resources and agents.

CONTROL CENTRES: usual care as dictated by clinical guidelines MEASUREMENTS: Patients will be followed during 12 months with 3 repeated measurements at baseline, 6 and 12 months. Programs' feasibility will be evaluated in terms of adoption, implementation and acceptability at professional level, and in terms of reach, exposure and acceptability at patient level. Regarding potential effectiveness, the observed change in patients' adoption of the minimum recommended level of the healthy lifestyle and the observed change in healthy lifestyles promotion practice of professionals through the Preventive Activities Questionnaire, will be assessed.

ANALYSIS: the investigators will compare intervention and control centers in the implementation rate of planned activities, the proportion of users exposed and the observed change in users' healthy lifestyles. Within the intervention group, the investigators will compare centers, each with different intensities of the programs components, to explore tolerable levels. Consensus techniques will be used to explore professionals' perceptions of program components usefulness.

Eligibility

Ages Eligible for Study:	10 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

primary care attendees not meeting at least one of the healthy lifestyles recommendations
10 to 65 years old

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365026

Contacts

Contact: Gonzalo Grandes, MD, MS	+34946006637	Gonzalo.Grandes@Osakidetza.net
Contact: Alvaro sanchez, PhD	+34 946006637	alvaro.sanchez@osakidetza.net

Locations

Spain
Primary Care Research Unit of Bizkaia	Recruiting
Bilbao, Spain, E48014
Contact: Gonzalo Grandes

Sponsors and Collaborators

Basque Health Service

Investigators

Principal Investigator:

Gonzalo Grandes, MD, MS

Basque Health Service

More Information

Publications:

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.

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.

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.

Grandes G, Sánchez A, Torcal J, Sánchez-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.

Responsible Party:	Gonzalo Grandes, MD, MSC Epidemiology, Basque Health Service
ClinicalTrials.gov Identifier:	NCT01365026 History of Changes
Other Study ID Numbers:	PS09/01461, 2009111072, G03/170 RD06/0018, CAIBERCAI08/01/00
Study First Received:	June 1, 2011
Last Updated:	September 10, 2012
Health Authority:	Spain: Ethics Committee

Keywords provided by Basque Health Service:

Healthy Lifestyle
Health promotion
Counselling
Action Plan
Primary Health Care

ClinicalTrials.gov processed this record on May 19, 2013

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