Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00131079
Status:
COMPLETED
Last Update Posted:
2018-03-21
First Post:
2005-08-16
Brief Title:
PEPAF Evaluation of Family Physicians Effectiveness for Physical Activity Promotion
Sponsor:
Basque Health Service
Organization:
Basque Health Service
Study Overview
Official Title:
Multi-center Evaluation of the Experimental Program for Physical Activity Promotion PEPAF Carried Out by Family Physicians
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| G03170 | None | None | None |
| PI020015 | None | None | None |