An interventional study of Sitting time Change Intervention in Overweight, Obese and Sedentary, sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. Status unknown at 1 site in Spain. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-02-10.
Sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Not applicable, Interventional, and Prevention
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.
3,670 studies on the registry are indexed under Overweight; 850 are open to participants now.
This study's planned enrollment of 450 is above the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina is the lead sponsor of 158 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Control visits to the Primary Health Care Center
Intervention to find alternatives to substitute sitting time by doing the regular activities standing or walking.
Also known as: SedestActiv Intervention
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.
Time frame: Baseline-6-9-12 and 18 month
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
Skinfolds and waist circumference
Time frame: Baseline-6-9-12 and 18 month
Triglycerides, total cholesterol and glucose
Time frame: Baseline-6-9-12 and 18 month
This study is status unknown, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina