OverweightSedestActivNCT01729936
SedestActiv Project: Intervention to Reduce Diary Hours of Sitting Time in Overweight and Obese Patients
A study testing Sitting time Change Intervention in people with Overweight and Obese, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Overweight, Obese, Sedentary
- What is being tested?
- Sitting time Change Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2012to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Recommended contradictions to advising physical activity to overweight and obese people.
- Have an obesity surgical operation.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
IDIAP Jordi Gol
Barcelona, Barcelona
Carme Martín-Borràs, sedestactiv@gmail.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Overweight, Obese, Sedentary
- Being tested
- Sitting time Change Intervention
- Keywords
- Sitting time, Overweight, Obese, Primary Health Care
- Medical subject headings
- Overweight, Obesity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sitting time Change InterventionBehavioural
Also called SedestActiv Intervention
Intervention to find alternatives to substitute sitting time by doing the regular activities standing or walking.
| Study group | Role | What they receive |
|---|---|---|
| Sitting time Change Intervention | Experimental | 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. Receives: Behavioral: Sitting time Change Intervention |
| Active Control | No intervention | Control visits to the Primary Health Care Center |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline-6-9-12 and 18 month
Secondary outcomes (4)
Number of steps walked
Measured: Baseline-6-9-12 and 18 month
Subjective level of physical activity
Measured: Baseline-6-9-12 and 18 month
Quality of life related to health
Measured: Baseline-6-9-12 and 18 month
Blood pressure
Measured: Baseline-6-9-12 and 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startJun 2012
- Primary completionFeb 2014 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Fondo de Investigacion Sanitaria, Preventive Services and Health Promotion Research Network
- Responsible party
- Sponsor
- Investigators
- Martínez R Elena, Principal investigator, Institut Català de la Salut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729936
- Sponsor's protocol ID
- PI11/01082
- Acronym
- SedestActiv
- Status last verified
- Feb 2014
- First submitted
- 1 Aug 2012
- Last updated
- 10 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 34207661Martin-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.
PubMed 24597534
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Intervention to Reduce Diary Hours of Sitting Time in Overweight and Obese Patients (SEDESACTIV):Simple Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01729936
- Acronym / sponsor ID
- SedestActiv / PI11/01082
- Conditions
- Overweight, Obese, Sedentary
- Keywords
- Sitting time, Overweight, Obese, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Fondo de Investigacion Sanitaria, Preventive Services and Health Promotion Research Network
- Study start
- Jun 2012
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitting time Change Intervention | Experimental | Behavioral: Sitting time Change InterventionSitting 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. |
| Active Control | No intervention | –Control visits to the Primary Health Care Center |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Recommended contradictions to advising physical activity to overweight and obese people.
- Have an obesity surgical operation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sitting time Change InterventionAlso: SedestActiv InterventionIntervention to find alternatives to substitute sitting time by doing the regular activities standing or walking. | Behavioural | Sitting time Change Intervention |
Primary outcome
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.
4 secondary outcomes
Number of steps walked
Time frame: Baseline-6-9-12 and 18 month
Subjective level of physical activity
Time frame: Baseline-6-9-12 and 18 month
Quality of life related to health
Time frame: Baseline-6-9-12 and 18 month
Blood pressure
Time frame: Baseline-6-9-12 and 18 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2014.
- Derived from this study: PubMed 34207661Rodriguez-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.
- Derived from this study: PubMed 24597534Martin-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martínez R Elena principal investigator
Institut Català de la Salut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sitting time Change Intervention in people with Overweight and Obese, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01729936, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2014.