SedestActiv Project: Intervention to Reduce Diary Hours of Sitting Time in Overweight and Obese Patients (SedestActiv)
Primary Purpose
Overweight, Obese, Sedentary
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Sitting time Change Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Overweight focused on measuring Sitting time, Overweight, Obese, Primary Health Care
Eligibility 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.
Sites / Locations
- IDIAP Jordi GolRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Sitting time Change Intervention
Active Control
Arm Description
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.
Control visits to the Primary Health Care Center
Outcomes
Primary Outcome Measures
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
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
Number of steps walked
Subjective level of physical activity
Quality of life related to health
Blood pressure
Full Information
NCT ID
NCT01729936
First Posted
August 1, 2012
Last Updated
February 7, 2014
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Instituto de Salud Carlos III, Fondo de Investigacion Sanitaria, Preventive Services and Health Promotion Research Network
1. Study Identification
Unique Protocol Identification Number
NCT01729936
Brief Title
SedestActiv Project: Intervention to Reduce Diary Hours of Sitting Time in Overweight and Obese Patients
Acronym
SedestActiv
Official Title
Effectiveness of an Intervention to Reduce Diary Hours of Sitting Time in Overweight and Obese Patients (SEDESACTIV):Simple Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Collaborators
Instituto de Salud Carlos III, Fondo de Investigacion Sanitaria, Preventive Services and Health Promotion Research Network
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obese, Sedentary
Keywords
Sitting time, Overweight, Obese, Primary Health Care
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sitting time Change Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Active Control
Arm Type
No Intervention
Arm Description
Control visits to the Primary Health Care Center
Intervention Type
Behavioral
Intervention Name(s)
Sitting time Change Intervention
Other Intervention Name(s)
SedestActiv Intervention
Intervention Description
Intervention to find alternatives to substitute sitting time by doing the regular activities standing or walking.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline-6-9-12 and 18 month
Secondary Outcome Measure Information:
Title
Number of steps walked
Time Frame
Baseline-6-9-12 and 18 month
Title
Subjective level of physical activity
Time Frame
Baseline-6-9-12 and 18 month
Title
Quality of life related to health
Time Frame
Baseline-6-9-12 and 18 month
Title
Blood pressure
Time Frame
Baseline-6-9-12 and 18 month
Other Pre-specified Outcome Measures:
Title
Skinfolds and waist circumference
Time Frame
Baseline-6-9-12 and 18 month
Title
Triglycerides, total cholesterol and glucose
Time Frame
Baseline-6-9-12 and 18 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martínez R Elena
Organizational Affiliation
Institut Català de la Salut
Official's Role
Principal Investigator
Facility Information:
Facility Name
IDIAP Jordi Gol
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carme Martín-Borràs
Email
sedestactiv@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
34207661
Citation
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.
Results Reference
derived
PubMed Identifier
24597534
Citation
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.
Results Reference
derived
Learn more about this trial
SedestActiv Project: Intervention to Reduce Diary Hours of Sitting Time in Overweight and Obese Patients
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