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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00131079
• Other study ID #: PI020015-G03/170
• Secondary ID: PI020015G03/170
• Status: Completed
• Phase: Phase 3
• First received: August 16, 2005
• Last updated: March 19, 2018
• Start date: October 2003
• Est. completion date: March 2006

Study information

• Verified date: October 2007
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4317
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Exercise
• Physical Fitness
• Quality of Life

Intervention

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.
• Control
Control general practitioners assessed physical activity and performed recruitment in a similar way but offered usual care

Locations

Country	Name	City	State
n/a

Sponsors (10)

Lead Sponsor	Collaborator
Basque Health Service	Carlos III Health Institute, Castilla-La Mancha Health Service, Castilla-León Health Service, Dalt Sant Joan primary care center (Health Service of Islas Baleares), Health Service of Andalucia, Preventive Services and Health Promotion Research Network, Public Health Service of Cataluña, Public Health Service of Galicia, Public Health Service of Madrid

References & Publications (7)

Eden KB, Orleans CT, Mulrow CD, Pender NJ, Teutsch SM. Does counseling by clinicians improve physical activity? A summary of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2002 Aug 6;137(3):208-15. Review. — View Citation

Grandes G, Cortada JM, Arrazola A, Laka JP. Predictors of long-term outcome of a smoking cessation programme in primary care. Br J Gen Pract. 2003 Feb;53(487):101-7. — View Citation

Grandes G, Cortada JM, Arrazola A. An evidence-based programme for smoking cessation: effectiveness in routine general practice. Br J Gen Pract. 2000 Oct;50(459):803-7. — View Citation

Grandes G, Sánchez A, Torcal J, Ortega Sánchez-Pinilla R, Lizarraga K, Serra J; Grupo PEPAF. [Protocol for the multi-centre evaluation of the Experimental Programme Promotion of Physical Activity (PEPAF)]. Aten Primaria. 2003 Nov 15;32(8):475-80. Spanish. — View Citation

Hillsdon M, Foster C, Thorogood M. Interventions for promoting physical activity. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD003180. Review. — View Citation

López-de-Munain J, Torcal J, López V, Garay J. Prevention in routine general practice: activity patterns and potential promoting factors. Prev Med. 2001 Jan;32(1):13-22. — View Citation

U. S. Department of Health and Human Services. Physical Activity and Health: a report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, 1996.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity level (7-day Physical Activity Recall [PAR])		six months from the start of the intervention
Secondary	Cardiorespiratory fitness		six months from the start of the intervention
Secondary	Health related quality of life (SF-36)		six months from the start of the intervention