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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01365026
Recruitment Status : Recruiting
First Posted : June 3, 2011
Last Update Posted : January 31, 2017
Information provided by (Responsible Party):
Gonzalo Grandes, Basque Health Service

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.

Condition or disease Intervention/treatment
Health Promotion Health Education Patient Education Counseling Behavior Therapy Health Behavior Behavioral: PVS: Programa de Vida Saludable

Detailed Description:

BACKGROUND: Primary health care (PHC) services have 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 efficacy of an implementation strategy for optimizing the promotion of physical activity, diet and smoking abstinence in PHC. The strategy is 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 hybrid implementation-effectiveness trial, conducted in 6 PHC centers (20 practices in 3 intervention centers and 21 in 3 control centers), with the collaboration of the majority of primary care professionals within each center, and the participation of 4017 attendees randomly selected from the target population. INTERVENTION CENTRES: Each of the intervention centers will be exposed to the PVS multicomponent implementation strategy, including training, information and communication electronic tools integrated into the electronic clinical record (ECR), local leadership, creation of a community of practice, practice facilitation, and audit and feed-back for the implementation of an intervention program to promote multiple healthy lifestyles (physical activity, healthy diet, and smoking cessation), based on the 5A's (Ask, Advise, Agree, Assist and Arrange follow-up), and modeled by professionals in each intervention center, according to their organizational context and available community resources and agents.

CONTROL CENTRES: will receive the same training and dissemination of clinical guidelines, electronic support tools integrated into the ECR, audit and feed-back.

MEASUREMENTS: Programs' implementation will be evaluated in terms of reach, adoption, implementation and acceptability by PHC staff, following the RE-AIM framework. PHC attendees will be followed with 2 repeated measurements at baseline, and 6 months to estimate change in patients' adoption of the minimum recommended level of healthy lifestyles.

ANALYSIS: the investigators will compare the implementation rate of health promotion activities in intervention and control centers, the proportion of users exposed to the 5 A's and the observed change in users' healthy lifestyles. Centers with different intensities of actual implementation will be compared to explore characteristics associated with implementation and the interaction between implementation strategies and clinical effectiveness of the intervention programs.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4017 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Feasibility and Effectiveness of Innovative Programs for Health Promotion in Primary Care: The 'Prescribe Healthy Life' Project (PVS)
Actual Study Start Date : January 6, 2016
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Living
U.S. FDA Resources

Arm Intervention/treatment
Experimental: PVS intervention Behavioral: PVS: Programa de Vida Saludable
Lifestyle counseling and prescription
No Intervention: Control group

Primary Outcome Measures :
  1. Health propmotion clinical practice change [ Time Frame: 12 months ]
    Rates and proportion of primary care attendees exposed to the 5 A's

  2. Adoption by primary care attendees of the minimum recommended levels of physical activity, fruits and vegetable consumption and smoking abstinence [ Time Frame: 6 months ]
    Change in at least one and number of modified lifestyle behaviors

Secondary Outcome Measures :
  1. Efficiency of healthy lifestyle prescription [ Time Frame: 6 months ]
    Costs and utility of the prescription of healthy behabior change plan

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01365026

Contact: Gonzalo Grandes, MD, MS +34946006637
Contact: Alvaro sanchez, PhD +34 946006637

Primary Care Research Unit of Bizkaia Recruiting
Bilbao, Spain, E48014
Contact: Gonzalo Grandes         
Sponsors and Collaborators
Basque Health Service
Principal Investigator: Gonzalo Grandes, MD, MS Basque Health Service


Responsible Party: Gonzalo Grandes, MD, MS Epidemiology, Basque Health Service Identifier: NCT01365026     History of Changes
Other Study ID Numbers: PS09/01461
2014111076 ( Other Grant/Funding Number: Basque Health Department )
PI13/00573 ( Other Grant/Funding Number: Carlos III Institute of Health, Spanish Ministry of Health )
RD12/0005/0010 ( Other Grant/Funding Number: Carlos III Institute of Health, Spanish Ministry of Health )
First Posted: June 3, 2011    Key Record Dates
Last Update Posted: January 31, 2017
Last Verified: January 2017

Keywords provided by Gonzalo Grandes, Basque Health Service:
Healthy Lifestyle
Health promotion
Action Plan
Primary Health Care