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
  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:


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: October 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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: July 23, 2013
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 August 01, 2014