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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
| Fondo de Investigacion Sanitaria | OTHER |
| Preventive Services and Health Promotion Research Network | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Active Control | No Intervention | Control visits to the Primary Health Care Center |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitting time Change Intervention | Behavioral | Intervention to find alternatives to substitute sitting time by doing the regular activities standing or walking. |
|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of steps walked | Baseline-6-9-12 and 18 month | |
| Subjective level of physical activity | Baseline-6-9-12 and 18 month | |
| Quality of life related to health |
| Measure | Description | Time Frame |
|---|---|---|
| Skinfolds and waist circumference | Baseline-6-9-12 and 18 month | |
| Triglycerides, total cholesterol and glucose | Baseline-6-9-12 and 18 month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martínez R Elena | Institut Català de la Salut | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IDIAP Jordi Gol | Recruiting | Barcelona | Barcelona | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34207661 | Derived | 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. | |
| 24597534 | Derived |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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|
| Baseline-6-9-12 and 18 month |
| Blood pressure | Baseline-6-9-12 and 18 month |
| 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. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |