PVS: Innovative Programs For Healthy Lifestyle Promotion in Primary Care: 'Prescribe Healthy Life'
Recruitment status was Recruiting
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.
Behavioral: PVS: Programa de Vida Saludable
|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)|
- 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
- Perceived preventive practice [ Time Frame: 12 months ] [ Designated as safety issue: No ]self reported change in preventive practices delivered by primary care professionals
|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)|
|Experimental: PVS intervention||
Behavioral: PVS: Programa de Vida Saludable
Lifestyle counseling and prescription
|No Intervention: Control group|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365026
|Contact: Gonzalo Grandes, MD, MS||+34946006637||Gonzalo.Grandes@Osakidetza.net|
|Contact: Alvaro sanchez, PhD||+34 firstname.lastname@example.org|
|Primary Care Research Unit of Bizkaia||Recruiting|
|Bilbao, Spain, E48014|
|Contact: Gonzalo Grandes|
|Principal Investigator:||Gonzalo Grandes, MD, MS||Basque Health Service|