Skip to content

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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00131079
Enrollment
4317
Registered
2005-08-17
Start date
2003-10-31
Completion date
2006-03-31
Last updated
2018-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise, Physical Fitness, Quality of Life

Keywords

Primary Health Care, Physicians, Family, Family Practice, Health Promotion, Randomized Controlled Trials, Multicenter Studies, Physical Fitness, Quality of Life

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.

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.

Interventions

BEHAVIORALExperimental 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.

BEHAVIORALControl

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frame
Physical activity level (7-day Physical Activity Recall [PAR])six months from the start of the intervention

Secondary

MeasureTime frame
Cardiorespiratory fitnesssix months from the start of the intervention
Health related quality of life (SF-36)six months from the start of the intervention

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026