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

February 7, 2014 updated by: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Sitting time Change Intervention
Intervention to find alternatives to substitute sitting time by doing the regular activities standing or walking.
Other Names:
  • SedestActiv Intervention
No Intervention: Active Control
Control visits to the Primary Health Care Center

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
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.
Baseline-6-9-12 and 18 month

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Skinfolds and waist circumference
Time Frame: Baseline-6-9-12 and 18 month
Baseline-6-9-12 and 18 month
Triglycerides, total cholesterol and glucose
Time Frame: Baseline-6-9-12 and 18 month
Baseline-6-9-12 and 18 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Collaborators

Fondo de Investigacion Sanitaria
Preventive Services and Health Promotion Research Network
Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Martínez R Elena, Institut Català de la Salut

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

August 1, 2012

First Submitted That Met QC Criteria

November 14, 2012

First Posted (Estimate)

November 21, 2012

Study Record Updates

Last Update Posted (Estimate)

February 10, 2014

Last Update Submitted That Met QC Criteria

February 7, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI11/01082

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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