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

This study has been completed.
Sponsor:
Collaborators:
Preventive Services and Health Promotion Research Network
Castilla-León Health Service
Health Service of Andalucia
Cuenca III primary care center (Health Service of Castilla La Mancha)
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
Information provided by:
Basque Health Service
ClinicalTrials.gov Identifier:
NCT00131079
First received: August 16, 2005
Last updated: October 16, 2007
Last verified: October 2007

August 16, 2005
October 16, 2007
October 2003
Not Provided
Physical activity level (7-day Physical Activity Recall [PAR]) [ Time Frame: six months from the start of the intervention ]
  • - Physical Activity Level (7-day PAR)
  • - Cardiorespiratory and Physical Fitness
  • - Health Related Quality of life (SF-36)
Complete list of historical versions of study NCT00131079 on ClinicalTrials.gov Archive Site
  • Cardiorespiratory fitness [ Time Frame: six months from the start of the intervention ]
  • Health related quality of life (SF-36) [ Time Frame: six months from the start of the intervention ]
Control of cardiovascular risk factors
Not Provided
Not Provided
 
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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
  • Exercise
  • Physical Fitness
  • Quality of Life
  • 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.

  • Behavioral: Control
    Control general practitioners assessed physical activity and performed recruitment in a similar way but offered usual care
  • 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.
    Intervention: Behavioral: Experimental Programme for Physical Activity Promotion
  • Active Comparator: Control
    Intervention: Behavioral: Control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4317
March 2006
Not Provided

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
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00131079
PI020015-G03/170, PI020015, G03/170
No
Not Provided
Basque Health Service
  • Preventive Services and Health Promotion Research Network
  • Castilla-León Health Service
  • Health Service of Andalucia
  • Cuenca III primary care center (Health Service of Castilla La Mancha)
  • 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)
Basque Health Service
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP