[Protocol for the multi-centre evaluation of the Experimental Programme Promotion of Physical Activity (PEPAF)]

Abstract

Objective: To evaluate the effectiveness of an innovative programme to promote physical activity (PEPAF) introduced into the daily consultations of the family doctor.

Design: Clinical trial with control, randomised for groups of 100 patients seen by one of the 70 doctors taking part, allocated to two parallel groups and monitored for 24 months.Setting. 13 primary care centres coordinated through the Network of Research into Preventive and Health Promotion Activities conducted in primary care.

Participants: Sample with probability of 7000 sedentary patients, selected from among those who consulted for any reason their family doctor during the third quarter of 2003. Patients with cardiovascular disease or other problems meaning that exercise could cause adverse effects will be excluded.

Interventions: The doctors allocated to the PEPAF will design a plan of physical activity with those patients prepared to make the change. Those not prepared to will be briefly counselled and given material to help them. All will be monitored at random. The control group doctors will postpone any systematic intervention on exercise until after 2005, excepting those patients whose health problem is directly related to a sedentary life-style.

Measurements: The main measurement of results will be the increase in the level of physical activity from the base measurement to those at 3, 6, 12 and 24 months, using 7-day physical activity recall. Health-related quality of life (SF 36) and physical fitness will also be measured. Variables that might be predictive or confusing, such as sex, age, comorbidity, social class, etc., will be considered. Analysis. The average changes observed in the two groups will be compared, on the basis of intention to treat, through analysis of covariance. We will use mixed-effect models able to cover the intra-patient, intra-doctor and intra-centre correlation.