PEPAF: Evaluation of Family Physician's Effectiveness for Physical Activity Promotion
|ClinicalTrials.gov Identifier: NCT00131079|
Recruitment Status : Completed
First Posted : August 17, 2005
Last Update Posted : October 17, 2007
|Condition or disease||Intervention/treatment||Phase|
|Exercise Physical Fitness Quality of Life||Behavioral: Experimental Programme for Physical Activity Promotion Behavioral: Control||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4317 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Multi-Center Evaluation of the Experimental Program for Physical Activity Promotion (PEPAF), Carried Out by Family Physicians|
|Study Start Date :||October 2003|
|Study Completion Date :||March 2006|
General Practitioner's assessment of physical activity level and minimal advice in routine clinical practice supplemented by physical activity prescription to those who accepted an additional 15 minutes appointment.
Behavioral: Experimental Programme for Physical Activity Promotion
General practitioner's (GP) physical activity (PA) assessment and advise using a web-based software that prompted open questions to elicit believes about benefits of PA, graphical information about risks of inactivity and examples of type sentences to provide medical advise.
Educational materials summarizing benefits, risks and motivation.
Prescription: 15 minutes educational session in which GP negotiated a goal, addressed possible barriers and anticipated solutions using web-based tools for lack of time, community resources, and health problems. Finally, they designed a 3-month PA activity plan that derived in a standardized printed prescription of frequency, duration, intensity and progression of a selected PA or exercise that included a self-monitoring log.
|Active Comparator: Control||
Control general practitioners assessed physical activity and performed recruitment in a similar way but offered usual care
- Physical activity level (7-day Physical Activity Recall [PAR]) [ Time Frame: six months from the start of the intervention ]
- Cardiorespiratory fitness [ Time Frame: six months from the start of the intervention ]
- Health related quality of life (SF-36) [ Time Frame: six months from the start of the intervention ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00131079
|Principal Investigator:||Gonzalo Grandes, Dr.||Primary Care Research Unit of Bizkaia (Basque Health Service)|