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| Sponsors and Collaborators: |
Basque Health Service Preventive Services and Health Promotion Research Network (redIAPP): 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 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Exercise Physical Fitness Quality of Life |
Behavioral: Experimental Programme for Physical Activity Promotion Behavioral: Control |
Phase III |
| Study Type: | Interventional |
| Study Design: | Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Multi-Center Evaluation of the Experimental Program for Physical Activity Promotion (PEPAF), Carried Out by Family Physicians |
| Enrollment: | 4317 |
| Study Start Date: | October 2003 |
| Study Completion Date: | March 2006 |
| Arms | Assigned Interventions |
|---|---|
|
PEPAF: Experimental
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. |
| Control: Active Comparator |
Behavioral: Control
Control general practitioners assessed physical activity and performed recruitment in a similar way but offered usual care
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Principal Investigator: | Gonzalo Grandes, Dr. | Primary Care Research Unit of Bizkaia (Basque Health Service) |
More Information
| Study ID Numbers: | PI020015-G03/170, PI020015, G03/170 |
| Study First Received: | August 16, 2005 |
| Last Updated: | October 16, 2007 |
| ClinicalTrials.gov Identifier: | NCT00131079 |
| Health Authority: | Spain: Ministry of Health |
|
Primary Health Care Physicians, Family Family Practice Health Promotion |
Randomized Controlled Trials Multicenter Studies Physical Fitness Quality of Life |
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Quality of Life |
