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

Not Applicable

• Conditions: Overweight; Obese; Sedentary
• Interventions: Behavioral: Sitting time Change Intervention

• Registration Number: NCT01729936
• Lead Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-08-01
• Study First Submitted QC: 2012-11-14
• Study First Posted: 2012-11-21
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Last Update Submitted: 2014-02-07
• Last Update Posted: 2014-02-10
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sitting time Change Intervention	Sitting time Change Intervention	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.

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
Subjective level of physical activity	Baseline-6-9-12 and 18 month
Number of steps walked	Baseline-6-9-12 and 18 month
Quality of life related to health	Baseline-6-9-12 and 18 month
Blood pressure	Baseline-6-9-12 and 18 month

Trial Locations

Locations (1)

IDIAP Jordi Gol; 🇪🇸 Barcelona, Spain