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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Reduction of Sitting Time: Sedentarism Intervention Trial

NCT01221363

Life Style Physical Activity Sedentary Behavior

COMPLETED NA

Effects of Disrupting Prolonged Sitting With Different Physical Activity Protocols on Metabolic Risk Factors in Sedentary Adults

NCT02215603

Prolonged Sitting Breaking Prolonged Sitting With Physical Activity

UNKNOWN NA

Referral From Primary Health Care Centers to a Physical Activity Program. A Randomized Controlled Trial

NCT00714831

Sedentary General Population

UNKNOWN NA

Metabolic Risk Management, Physical Exercise and Lifestyle Counselling in Low-active Adults; Controlled Randomized Trial

NCT02832453

Metabolic Syndrome X Lifestyle-related Condition Lifestyle Risk Reduction +1 more

COMPLETED NA

Trial to Reduce Sitting Time in Postmenopausal Latina Women at Increased Risk for Heart Disease

NCT02905929

Sedentary Lifestyle

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overweight Obese Sedentary

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Sitting time Change Intervention

Intervention Type BEHAVIORAL

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

Active Control

Control visits to the Primary Health Care Center

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sitting time Change Intervention

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

SedestActiv Intervention

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.