PEPAF: Evaluation of Family Physician's Effectiveness for Physical Activity Promotion

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multi-center Evaluation of the Experimental Program for Physical Activity Promotion (PEPAF), Carried Out by Family Physicians

Conditions
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Exercise, Physical Fitness, Quality of Life

Intervention / Treatment
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* Behavioral: Experimental Programme for Physical Activity Promotion
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEPAF<br>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<br>* 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.<br>|
| Active Comparator: Control<br> | Behavioral: Control<br>* Control general practitioners assessed physical activity and performed recruitment in a similar way but offered usual care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity level (7-day Physical Activity Recall [PAR]) |  | six months from the start of the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiorespiratory fitness |  | six months from the start of the intervention | 
| Health related quality of life (SF-36) |  | six months from the start of the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Health Care, Physicians, Family, Family Practice, Health Promotion, Randomized Controlled Trials, Multicenter Studies, Physical Fitness, Quality of Life