Referral From Primary Health Care Centers to a Physical Activity Program. A Randomized Controlled Trial
|ClinicalTrials.gov Identifier: NCT00714831|
Recruitment Status : Unknown
Verified July 2008 by Jordi Gol i Gurina Foundation.
Recruitment status was: Not yet recruiting
First Posted : July 14, 2008
Last Update Posted : July 14, 2008
|Condition or disease||Intervention/treatment||Phase|
|Sedentary General Population||Behavioral: Physical activity intervention Behavioral: Health educational program||Not Applicable|
Physical inactivity has emerged as an important risk factor for many chronic diseases. The decline in physical activity is a key public health concern.
Objective. The objective of the study is to assess the effectiveness of a 3-months physical activity programme in the primary healthcare centres (HC), combined with community resources and interdisciplinary work, to create adherence to physical activity in sedentary individuals.
Methods. The design of the study is a randomized controlled trial with a randomized selection of the sample. A total of 424 subjects of both sexes, older than 18 years old, with a low physical activity level (IPAQ), independent, with no medical contraindication to practice physical activity, and coming from 8 different HC, will participate in the study. Each subject will be offered to participate voluntarily in a physical activity programme (24 sessions, twice a week, 60 minutes/session). There will be two groups of 15-20 subjects in each HC (a total of 8 HC), randomizing the subjects of the intervention (GI) and control groups (GC). The study will be divided in two phases, and in each phase there will be 16 groups (8 GC and 8 GI).
In the first and last session different parameters will be assessed in all the subjects (GC and GI): (1) quality of life related to health with SF-12 questionnaire, (2) the attitude towards practicing physical activity with Prochaska stage changes, (3) the physical activity level with the reduced version of the IPAQ, (4) health perception with COOP/WONCA questionnaire, and (5) the social support for physical activity with SSPAS. The welfare pressure to the HC of each participant is also registered, during the 6 months previous and after the programme. Subjects of GI will go through the 24 sessions while subjects of GC will go through a health educational program and will be asked to continue with their everyday activities. After 3, 6 and 12 months of the end of the programme, a pursuit by means of a call will be done (IPAQ, SF-12 and SSPAS). After 6 and 12 months of the end of the programme the same call will be used to assess the Prochaska stages.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||424 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Referral From Primary Health Care Centers to a Physical Activity Program: Establishing Long-Term Adherence? A Randomized Controlled Trial|
|Study Start Date :||September 2008|
|Estimated Primary Completion Date :||September 2010|
|Estimated Study Completion Date :||December 2010|
Active Comparator: CG
Behavioral: Health educational program
Health education sessions and stretching sessions
Behavioral: Physical activity intervention
3-months physical activity intervention
- This randomized controlled trial was designed to assess the effectiveness of a primary care physical activity intervention, in increasing adherence to physical activity in general population, as well as their self-reported physical activity. [ Time Frame: baseline-3-6-12-18 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00714831
|Contact: Maria Giné-Garriga, MS||+34 firstname.lastname@example.org|
|Contact: Carme Martin-Borràs, MS||+34 email@example.com|
|Primary Health Care||Not yet recruiting|
|Barcelona, Spain, 08022|
|Contact: Maria Giné-Garriga, MS +34 675785983 firstname.lastname@example.org|
|Principal Investigator: Maria Giné-Garriga, MS|
|Principal Investigator: Carme Martin-Borràs, MS|
|Sub-Investigator: Carlos Martin, PhD, MD|
|Sub-Investigator: Anna Puig-Ribera, PhD|
|Sub-Investigator: Juan José Anton, MD|
|Sub-Investigator: Agustí Guiu, MD|
|Sub-Investigator: Ana Cascos, Nurse|
|Study Director:||Carlos Martin, PhD, MD||Primary Health Care of Barcelona|