- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01729936
SedestActiv Project: Intervention to Reduce Diary Hours of Sitting Time in Overweight and Obese Patients (SedestActiv)
Effectiveness of an Intervention to Reduce Diary Hours of Sitting Time in Overweight and Obese Patients (SEDESACTIV):Simple Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Barcelona, Spain
- Recruiting
- IDIAP Jordi Gol
-
Contact:
- Carme Martín-Borràs
- Email: sedestactiv@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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. |
Intervention to find alternatives to substitute sitting time by doing the regular activities standing or walking.
Other Names:
|
No Intervention: Active Control
Control visits to the Primary Health Care Center
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline-6-9-12 and 18 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of steps walked
Time Frame: Baseline-6-9-12 and 18 month
|
Baseline-6-9-12 and 18 month
|
Subjective level of physical activity
Time Frame: Baseline-6-9-12 and 18 month
|
Baseline-6-9-12 and 18 month
|
Quality of life related to health
Time Frame: Baseline-6-9-12 and 18 month
|
Baseline-6-9-12 and 18 month
|
Blood pressure
Time Frame: Baseline-6-9-12 and 18 month
|
Baseline-6-9-12 and 18 month
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Skinfolds and waist circumference
Time Frame: Baseline-6-9-12 and 18 month
|
Baseline-6-9-12 and 18 month
|
Triglycerides, total cholesterol and glucose
Time Frame: Baseline-6-9-12 and 18 month
|
Baseline-6-9-12 and 18 month
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Martínez R Elena, Institut Català de la Salut
Publications and helpful links
General Publications
- Rodriguez-Roca B, Urcola-Pardo F, Anguas-Gracia A, Subiron-Valera AB, Gasch-Gallen A, Anton-Solanas I, Gascon-Catalan AM. Impact of Reducing Sitting Time in Women with Fibromyalgia and Obesity: A Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Jun 9;18(12):6237. doi: 10.3390/ijerph18126237.
- Martin-Borras C, Gine-Garriga M, Martinez E, Martin-Cantera C, Puigdomenech E, Sola M, Castillo E, Beltran AM, Puig-Ribera A, Trujillo JM, Pueyo O, Pueyo J, Rodriguez B, Serra-Paya N; SEDESTACTIV Study Group. Effectiveness of a primary care-based intervention to reduce sitting time in overweight and obese patients (SEDESTACTIV): a randomized controlled trial; rationale and study design. BMC Public Health. 2014 Mar 5;14:228. doi: 10.1186/1471-2458-14-228.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI11/01082
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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