PEPAF: Evaluation of Family Physician's Effectiveness for Physical Activity Promotion
|First Received Date ICMJE||August 16, 2005|
|Last Updated Date||October 16, 2007|
|Start Date ICMJE||October 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Physical activity level (7-day Physical Activity Recall [PAR]) [ Time Frame: six months from the start of the intervention ]|
|Original Primary Outcome Measures ICMJE
|Change History||Complete list of historical versions of study NCT00131079 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
||Control of cardiovascular risk factors|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||PEPAF: Evaluation of Family Physician's Effectiveness for Physical Activity Promotion|
|Official Title ICMJE||Multi-Center Evaluation of the Experimental Program for Physical Activity Promotion (PEPAF), Carried Out by Family Physicians|
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.
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 ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
|Study Arm (s)||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||March 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||20 Years to 80 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Not Provided|
|NCT Number ICMJE||NCT00131079|
|Other Study ID Numbers ICMJE||PI020015-G03/170, PI020015, G03/170|
|Has Data Monitoring Committee||No|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Basque Health Service|
|Information Provided By||Basque Health Service|
|Verification Date||October 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP