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SedestActiv Project: Intervention to Reduce Diary Hours of Sitting Time in Overweight and Obese Patients (SedestActiv)

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ClinicalTrials.gov Identifier: NCT01729936
Recruitment Status : Unknown
Verified February 2014 by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina.
Recruitment status was:  Recruiting
First Posted : November 21, 2012
Last Update Posted : February 10, 2014
Sponsor:
Collaborators:
Instituto de Salud Carlos III
Fondo de Investigacion Sanitaria
Preventive Services and Health Promotion Research Network
Information provided by (Responsible Party):
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Study Description
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Brief Summary:

Primary care centres are a key setting to treat people with overweight and moderate obesity. There is growing evidence that sitting for a long time is negatively associated with people's health. Interventions with the aim of reducing daily time of sedentary activities can be an effective strategy to increase daily energy expenditure. To improve the effectiveness of programmes promoting physical activity in primary care we need some clear action protocols that can be easily integrated in the daily routines of primary care professionals.

Objective. The objective of the study is to evaluate the effectiveness of a six-moth primary care intervention to reduce diary hours of sitting time in overweight and obese sedentary patients, as well as to increase their weekly caloric spend.

Methods. The design of the study is a simple randomized controlled trial. Ten primary care centers will be invited to participate and will be randomized into control (CG) and intervention group (IG). Each professional will randomly invite to participate voluntarily moderate obese or overweight patients (BMI: 25-34,9 kg/m2) of both sexes, aged between 25 and 65 years old, who are 6 or more than 6 hours daily sitting. A total of 400 subjects (200 individuals in each group) are needed. In addition, 50 subjects with fibromyalgia will be included in the study to know the feasibility of the intervention among them.

The main dependent variable (sitting times) will be measured with an ActivPAL during first and last intervention week. There will be a follow up after 3, 6 and 12 months of the end of the intervention. Other variables included in the study: number of steps walked, subjective level of physical activity, weight, height, BMI, skinfolds, waist circumference, triglycerides, total cholesterol, (LDL and HDL), glucose, sociodemographic variables, blood pressure and quality of life related to health. A descriptive analysis of all variables and a multivariate analysis to assess differences among intervention and control group will be undertaken. Multivariate analysis will be carried out to assess time changes of dependent variables. All the analysis will be done under the intention to treat principle.


Condition or disease Intervention/treatment Phase
Overweight Obese Sedentary Behavioral: Sitting time Change Intervention Not Applicable

Detailed Description:
The intervention will be based on a recommendation to find alternatives to progressively substitute Sitting time by doing the regular activities standing or walking. Control group will receive minimum advice.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness of an Intervention to Reduce Diary Hours of Sitting Time in Overweight and Obese Patients (SEDESACTIV):Simple Randomized Controlled Trial
Study Start Date : June 2012
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : December 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: Sitting time Change Intervention

Sitting time Change Intervention: recommendation to substitute Sitting time by doing the regular activities standing or walking.

Duration: 6 month. Frequency: 1 time each 15 days during the first 4 month and 1 time each month the last 2 months.

 Behavioral: Sitting time Change Intervention
Intervention to find alternatives to substitute sitting time by doing the regular activities standing or walking.
Other Name: SedestActiv Intervention
No Intervention: Active Control
Control visits to the Primary Health Care Center


Outcome Measures
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Primary Outcome Measures :
  1. To assess the effectiveness of a 6-month primary care intervention to reduce diary hours of Sitting time in overweight and obese patients, as well as to increase their weekly caloric spend [ Time Frame: Baseline-6-9-12 and 18 month ]
    In this part of the study will use two measure tools: 1) A sitting time test during a working day and during the weekends (Marshall Test). 2) The activPal device will measure the sitting, stand and walking minutes and Mets expended during a week period.


Secondary Outcome Measures :
  1. Number of steps walked [ Time Frame: Baseline-6-9-12 and 18 month ]
  2. Subjective level of physical activity [ Time Frame: Baseline-6-9-12 and 18 month ]
  3. Quality of life related to health [ Time Frame: Baseline-6-9-12 and 18 month ]
  4. Blood pressure [ Time Frame: Baseline-6-9-12 and 18 month ]

Other Outcome Measures:
  1. Skinfolds and waist circumference [ Time Frame: Baseline-6-9-12 and 18 month ]
  2. Triglycerides, total cholesterol and glucose [ Time Frame: Baseline-6-9-12 and 18 month ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Overweight and moderate obese patients (BMI: 25-34,9 kg/m2).
  • Be 6 or more than 6 hours daily sitting.
  • Able to walk and stand up from a chair unaided.
  • Subjects who can guarantee a year continuity in the study.

Exclusion Criteria:

  • Recommended contradictions to advising physical activity to overweight and obese people.
  • Have an obesity surgical operation.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01729936


Locations
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Spain
IDIAP Jordi Gol Recruiting
Barcelona, Spain
Contact: Carme Martín-Borràs       sedestactiv@gmail.com   
Sponsors and Collaborators
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Instituto de Salud Carlos III
Fondo de Investigacion Sanitaria
Preventive Services and Health Promotion Research Network
Investigators
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Principal Investigator: Martínez R Elena Institut Català de la Salut
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
ClinicalTrials.gov Identifier: NCT01729936    
Other Study ID Numbers: PI11/01082
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: February 10, 2014
Last Verified: February 2014
Keywords provided by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina:
Sitting time
Overweight
Obese
Primary Health Care
Additional relevant MeSH terms:
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Overweight
Overnutrition
Nutrition Disorders
Body Weight