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SedestActiv Project: Intervention to Reduce Diary Hours of Sitting Time in Overweight and Obese Patients

Effectiveness of an Intervention to Reduce Diary Hours of Sitting Time in Overweight and Obese Patients (SEDESACTIV):Simple Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01729936
Acronym
SedestActiv
Enrollment
450
Registered
2012-11-21
Start date
2012-06-30
Completion date
2016-12-31
Last updated
2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese, Overweight, Sedentary

Keywords

Sitting time, Overweight, Obese, Primary Health Care

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.

Interventions

BEHAVIORALSitting time Change Intervention

Intervention to find alternatives to substitute sitting time by doing the regular activities standing or walking.

Sponsors

Instituto de Salud Carlos III
CollaboratorOTHER_GOV
Fondo de Investigacion Sanitaria
CollaboratorOTHER
Preventive Services and Health Promotion Research Network
CollaboratorOTHER
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 spendBaseline-6-9-12 and 18 monthIn 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

MeasureTime frame
Number of steps walkedBaseline-6-9-12 and 18 month
Subjective level of physical activityBaseline-6-9-12 and 18 month
Quality of life related to healthBaseline-6-9-12 and 18 month
Blood pressureBaseline-6-9-12 and 18 month

Other

MeasureTime frame
Skinfolds and waist circumferenceBaseline-6-9-12 and 18 month
Triglycerides, total cholesterol and glucoseBaseline-6-9-12 and 18 month

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026