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

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ClinicalTrials.gov Identifier: NCT00131079
Recruitment Status : Completed
First Posted : August 17, 2005
Last Update Posted : October 17, 2007
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Exercise Physical Fitness Quality of Life Behavioral: Experimental Programme for Physical Activity Promotion Behavioral: Control Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4317 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: PEPAF
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 Behavioral: Control
Control general practitioners assessed physical activity and performed recruitment in a similar way but offered usual care

Outcome Measures

Primary Outcome Measures :
  1. Physical activity level (7-day Physical Activity Recall [PAR]) [ Time Frame: six months from the start of the intervention ]

Secondary Outcome Measures :
  1. Cardiorespiratory fitness [ Time Frame: six months from the start of the intervention ]
  2. Health related quality of life (SF-36) [ Time Frame: six months from the start of the intervention ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00131079

Sponsors and Collaborators
Basque Health Service
Preventive Services and Health Promotion Research Network
Castilla-León Health Service
Health Service of Andalucia
Castilla-La Mancha Health Service
Dalt Sant Joan primary care center (Health Service of Islas Baleares)
Public Health Service of Madrid
Public Health Service of Galicia
Public Health Service of Cataluña
Carlos III Health Institute
Principal Investigator: Gonzalo Grandes, Dr. Primary Care Research Unit of Bizkaia (Basque Health Service)
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00131079     History of Changes
Other Study ID Numbers: PI020015-G03/170
First Posted: August 17, 2005    Key Record Dates
Last Update Posted: October 17, 2007
Last Verified: October 2007

Keywords provided by Basque Health Service:
Primary Health Care
Physicians, Family
Family Practice
Health Promotion
Randomized Controlled Trials
Multicenter Studies
Physical Fitness
Quality of Life