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

Feasibility and Effectiveness of Innovative Programs for Health Promotion in Primary Care: The 'Prescribe Healthy Life' Project (PVS)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01365026
Acronym
PVS
Enrollment
4017
Registered
2011-06-03
Start date
2016-01-06
Completion date
2018-12-31
Last updated
2017-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavior Therapy, Counseling, Health Behavior, Health Education, Health Promotion, Patient Education

Keywords

Healthy Lifestyle, Health promotion, Counselling, Action Plan, Primary Health Care

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.

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.

Interventions

BEHAVIORALPVS: Programa de Vida Saludable

Lifestyle counseling and prescription

Sponsors

Basque Health Service
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Health propmotion clinical practice change12 monthsRates and proportion of primary care attendees exposed to the 5 A's
Adoption by primary care attendees of the minimum recommended levels of physical activity, fruits and vegetable consumption and smoking abstinence6 monthsChange in at least one and number of modified lifestyle behaviors

Secondary

MeasureTime frameDescription
Efficiency of healthy lifestyle prescription6 monthsCosts and utility of the prescription of healthy behabior change plan

Countries

Spain

Contacts

Primary ContactGonzalo Grandes, MD, MS
Gonzalo.Grandes@Osakidetza.net+34946006637
Backup ContactAlvaro sanchez, PhD
alvaro.sanchez@osakidetza.net+34 946006637

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026