NCT01729936

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 10, 2014

Status Verified

February 1, 2014

Enrollment Period

1.7 years

First QC Date

August 1, 2012

Last Update Submit

February 7, 2014

Conditions

OverweightObeseSedentary

Keywords

Sitting timeOverweightObesePrimary Health Care

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline-6-9-12 and 18 month

Secondary Outcomes (4)

  • Number of steps walked

    Baseline-6-9-12 and 18 month

  • Subjective level of physical activity

    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

Other Outcomes (2)

  • Skinfolds and waist circumference

    Baseline-6-9-12 and 18 month

  • Triglycerides, total cholesterol and glucose

    Baseline-6-9-12 and 18 month

Study Arms (2)

Sitting time Change Intervention

EXPERIMENTAL

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

Active Control

NO INTERVENTION

Control visits to the Primary Health Care Center

Interventions

Sitting time Change InterventionBEHAVIORAL

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

Also known as: SedestActiv Intervention
Sitting time Change Intervention

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Recommended contradictions to advising physical activity to overweight and obese people.
  • Have an obesity surgical operation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IDIAP Jordi Gol

Barcelona, Barcelona, Spain

RECRUITING

Related Publications (2)

  • Rodriguez-Roca B, Urcola-Pardo F, Anguas-Gracia A, Subiron-Valera AB, Gasch-Gallen A, Anton-Solanas I, Gascon-Catalan AM. Impact of Reducing Sitting Time in Women with Fibromyalgia and Obesity: A Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Jun 9;18(12):6237. doi: 10.3390/ijerph18126237.

    PMID: 34207661DERIVED

  • Martin-Borras C, Gine-Garriga M, Martinez E, Martin-Cantera C, Puigdomenech E, Sola M, Castillo E, Beltran AM, Puig-Ribera A, Trujillo JM, Pueyo O, Pueyo J, Rodriguez B, Serra-Paya N; SEDESTACTIV Study Group. Effectiveness of a primary care-based intervention to reduce sitting time in overweight and obese patients (SEDESTACTIV): a randomized controlled trial; rationale and study design. BMC Public Health. 2014 Mar 5;14:228. doi: 10.1186/1471-2458-14-228.

    PMID: 24597534DERIVED

MeSH Terms

Conditions

OverweightObesitySedentary Behavior

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Martínez R Elena

    Institut Català de la Salut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2012

First Posted

November 21, 2012

Study Start

June 1, 2012

Primary Completion

February 1, 2014

Study Completion

December 1, 2016

Last Updated

February 10, 2014

Record last verified: 2014-02

Locations

ES(1)