Clinical trial NCT00131079: PEPAF: Evaluation of Family Physician's Effectiveness for Physical Activity Promotion
Official title: Multi-center Evaluation of the Experimental Program for Physical Activity Promotion (PEPAF), Carried Out by Family Physicians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Exercise
Physical Fitness
Quality of Life
Keywords: Primary Health Care
Physicians, Family
Family Practice
Health Promotion
Randomized Controlled Trials
Multicenter Studies
Physical Fitness
Quality of Life
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
Collaborators: name: Preventive Services and Health Promotion Research Network
name: Castilla-León Health Service
name: Health Service of Andalucia
name: Castilla-La Mancha Health Service
name: Dalt Sant Joan primary care center (Health Service of Islas Baleares)
name: Public Health Service of Madrid
name: Public Health Service of Galicia
name: Public Health Service of Cataluña
name: Carlos III Health Institute
First posted: 2005-08-17
Enrollment: 4317
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The potential health gains from active lifestyles are very well-known and it is recommended that all adults dedicate at least 30 minutes to activities of at least moderate intensity at least five days a week. What is still not known is how to help sedentary people follow this recommendation, by means of brief interventions feasible in routine general practice. This multi-center study was designed to evaluate the effectiveness of a physical activity promotion program (called PEPAF) implemented in 56 general practices of the Spanish public primary health care system. The study will test the capacity of the program to increase the physical activity level, physical fitness and health related quality of life of sedentary people.

Detailed description: Despite sedentary behavior being one of the strongest risk factors for chronic diseases and mortality, most of the population remains sedentary and evidence is inconclusive that counseling adults in the primary care setting to increase physical activity is effective.

The OBJECTIVE of this randomized clinical trial was to evaluate the effectiveness of an innovative programme to promote physical activity (called PEPAF) implemented by family doctors into daily routine practice. Doctors randomly allocated to the PEPAF group identified sedentary people who visited them for any reason, diagnosed their stage of change and prescribed a written plan of physical activity with those patients ready to change. Those not prepared to change were briefly counseled and given printed materials to motivate them. Patients with cardiovascular disease or other problems meaning that exercise could cause adverse effects were excluded.

Participating people will be followed for 24 months to measure the increase in the level of physical activity from baseline measurement to 6, 12 and 24 months, using 7-day physical activity recall. Health-related quality of life and cardiorespiratory fitness (submaximal cycle ergometer test) will also be measured.

People assigned to the PEPAF group will be COMPARED to patients of family doctors randomly assigned to the control group in which any systematic intervention on physical activity promotion has been postponed until year 2006, except for those patients whose health problems were directly related to a sedentary lifestyle. The average changes observed in the two groups will be compared, on the basis of intention to treat through analysis of covariance. The investigators will use mixed-effect models to take into account intra-patient, intra-doctor and intra-center correlation.

Eligibility criteria: Inclusion Criteria:

* Sedentary people who visit the general practitioner for any reason (those who do not dedicate at least 30 minutes to activities of at least moderate intensity at least five days a week).

Exclusion Criteria:

* Disorders of the cardiovascular system
* Transplant recipients
* Renal or hepatic failure
* Severe chronic obstructive pulmonary disease
* Severe mental disorders
* Chronic and acute severe infections
* Metabolic uncontrolled disorders
* Restrictive pathology of muscles, bones and joints
* Complicated pregnancy
* Contact difficulties

Primary outcomes:
measure: Physical activity level (7-day Physical Activity Recall [PAR])
timeFrame: six months from the start of the intervention
Secondary outcomes:
measure: Cardiorespiratory fitness
timeFrame: six months from the start of the intervention
measure: Health related quality of life (SF-36)
timeFrame: six months from the start of the intervention
Other outcomes:
Locations:
Study officials:
affiliation: Primary Care Research Unit of Bizkaia (Basque Health Service)
name: Gonzalo Grandes, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grandes G, Sanchez A, Torcal J, Ortega Sanchez-Pinilla R, Lizarraga K, Serra J; Grupo PEPAF. [Protocol for the multi-centre evaluation of the Experimental Programme Promotion of Physical Activity (PEPAF)]. Aten Primaria. 2003 Nov 15;32(8):475-80. doi: 10.1016/s0212-6567(03)79318-4. Spanish.
citation: Hillsdon M, Foster C, Thorogood M. Interventions for promoting physical activity. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD003180. doi: 10.1002/14651858.CD003180.pub2.
citation: Eden KB, Orleans CT, Mulrow CD, Pender NJ, Teutsch SM. Does counseling by clinicians improve physical activity? A summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2002 Aug 6;137(3):208-15. doi: 10.7326/0003-4819-137-3-200208060-00015.
citation: Lopez-de-Munain J, Torcal J, Lopez V, Garay J. Prevention in routine general practice: activity patterns and potential promoting factors. Prev Med. 2001 Jan;32(1):13-22. doi: 10.1006/pmed.2000.0777.
citation: U. S. Department of Health and Human Services. Physical Activity and Health: a report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, 1996.
citation: Grandes G, Cortada JM, Arrazola A, Laka JP. Predictors of long-term outcome of a smoking cessation programme in primary care. Br J Gen Pract. 2003 Feb;53(487):101-7.
citation: Grandes G, Cortada JM, Arrazola A. An evidence-based programme for smoking cessation: effectiveness in routine general practice. Br J Gen Pract. 2000 Oct;50(459):803-7.
citation: Grandes G, Sanchez A, Montoya I, Ortega Sanchez-Pinilla R, Torcal J; PEPAF Group. Two-year longitudinal analysis of a cluster randomized trial of physical activity promotion by general practitioners. PLoS One. 2011 Mar 29;6(3):e18363. doi: 10.1371/journal.pone.0018363.
citation: Grandes G, Sanchez A, Sanchez-Pinilla RO, Torcal J, Montoya I, Lizarraga K, Serra J; PEPAF Group. Effectiveness of physical activity advice and prescription by physicians in routine primary care: a cluster randomized trial. Arch Intern Med. 2009 Apr 13;169(7):694-701. doi: 10.1001/archinternmed.2009.23.