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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 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: July 23, 2013
Last verified: July 2013

June 1, 2011
July 23, 2013
June 2011
October 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01365026 on ClinicalTrials.gov Archive Site
Perceived preventive practice [ Time Frame: 12 months ] [ Designated as safety issue: No ]
self reported change in preventive practices delivered by primary care professionals
Same as current
Not Provided
Not Provided
 
PVS: Innovative Programs For Healthy Lifestyle Promotion in Primary Care: 'Prescribe Healthy Life'
Feasibility and Potential Effectiveness of Innovative Programs for Health Promotion in Primary Care: The 'Prescribe Healthy Life' Project (PVS)

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Health Promotion
  • Health Education
  • Patient Education
  • Counseling
  • Behavior Therapy
  • Health Behavior
Behavioral: PVS: Programa de Vida Saludable
Lifestyle counseling and prescription
  • Experimental: PVS intervention
    Intervention: Behavioral: PVS: Programa de Vida Saludable
  • No Intervention: Control group

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1366
December 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
10 Years to 65 Years
Yes
Contact: Gonzalo Grandes, MD, MS +34946006637 Gonzalo.Grandes@Osakidetza.net
Contact: Alvaro sanchez, PhD +34 946006637 alvaro.sanchez@osakidetza.net
Spain
 
NCT01365026
PS09/01461, 2009111072, G03/170 RD06/0018, CAIBERCAI08/01/00
No
Gonzalo Grandes, Basque Health Service
Basque Health Service
Not Provided
Principal Investigator: Gonzalo Grandes, MD, MS Basque Health Service
Basque Health Service
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP