NCT03101228

Brief Summary

The most important objective of this randomized controlled trial in subjects with increased cardiovascular and metabolic risk factors is to investigate whether only reduced daily sitting improves human cardiovascular and metabolic health during a six-month intervention. It is hypothesized and expected that only reduced sitting, without formal physical activity or exercise training, affects favorably cardiovascular and metabolic health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 24, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 5, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

April 25, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2020

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2020

Completed
Last Updated

April 8, 2020

Status Verified

April 1, 2020

Enrollment Period

2.8 years

First QC Date

March 24, 2017

Last Update Submit

April 7, 2020

Conditions

Keywords

Physical ActivityMetabolic SyndromeInsulin SensitivityCardiovascular Risk FactorSedentary LifestyleAccelerometry

Outcome Measures

Primary Outcomes (2)

  • The change in whole-body insulin sensitivity

    M-value during the hyperinsulinemic euglycemic clamp

    The change from baseline to 6 months

  • The change in skeletal muscle insulin-stimulated glucose uptake

    Glucose uptake in the femoral muscles will be measured by positron emission tomography (PET) with \[18F\]-labelled fluoro-deoxy-glucose (FDG) tracer during hyperinsulinemic euglycemic clamp

    The change from baseline to 6 months

Secondary Outcomes (10)

  • daily sitting hours

    through study completion, an average of 6 months

  • daily hours spent physically active

    through study completion, an average of 6 months

  • The change in liver adiposity

    The change from baseline to 6 months

  • The change in maximal oxygen uptake

    The change from baseline to 6 months

  • The change in body fat percentage

    The change from baseline to 3 months

  • +5 more secondary outcomes

Study Arms (2)

Reduced sitting

EXPERIMENTAL

Objectively measured daily inactive time will be reduced by one hour compared to the baseline.

Behavioral: Reduced sitting

Control

NO INTERVENTION

Subjects will be guided to maintain their normal sedentary behaviour and physical activity habits.

Interventions

Reduced sittingBEHAVIORAL

Subjects are guided to limit their sitting time during the day for 1 hour/day, by adding light activity with the help of an activity monitor. Subjects are not encouraged to increase their moderate to vigorous physical activity levels.

Reduced sitting

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physically inactive (less than 120 minutes of moderate intensity exercise per week measured by the activity monitor during run-in)
  • Sitting time ≥ 10 h /day (measured by the activity monitor during run-in)
  • BMI 25-40
  • Blood pressure \< 160/100 mmHg
  • Fasting plasma glucose \< 7.0 mmol/l
  • Fulfills the criteria of the metabolic syndrome according to Alberti et al 2009

You may not qualify if:

  • History of a cardiac event
  • Insulin or medically treated diabetes
  • Any chronic disease or condition that could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results
  • Presence of ferromagnetic objects that would make MR imaging contraindicated
  • Abundant use of alcohol
  • Use of narcotics
  • Smoking of tobacco or consuming snuff tobacco
  • Diagnosed depressive or bipolar disorder
  • Previous PET imaging or considerable exposure to radiation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku PET Centre

Turku, 20521, Finland

Location

Related Publications (8)

  • Norha J, Sjoros T, Garthwaite T, Laine S, Laitinen K, Houttu N, Vaha-Ypya H, Sievanen H, Loyttyniemi E, Vasankari T, Knuuti J, Kalliokoski KK, Heinonen IHA. Secondary analysis of a randomised controlled trial on reducing sedentary behaviour and its effects on quality of life and wellbeing. Sci Rep. 2025 Oct 22;15(1):36861. doi: 10.1038/s41598-025-20836-7.

  • Garthwaite T, Sjoros T, Laine S, Koivumaki M, Vaha-Ypya H, Norha J, Kallio P, Saarenhovi M, Loyttyniemi E, Sievanen H, Houttu N, Laitinen K, Kalliokoski KK, Vasankari T, Knuuti J, Heinonen I. Successfully Reducing Sitting Time Can Improve Metabolic Flexibility. Scand J Med Sci Sports. 2025 Aug;35(8):e70113. doi: 10.1111/sms.70113.

  • Ylinen VP, Sjoros T, Laine S, Garthwaite T, Norha J, Vaha-Ypya H, Loyttyniemi E, Houttu N, Laitinen K, Kalliokoski KK, Sievanen H, Vasankari T, Knuuti J, Heinonen IH. Sedentary behavior reduction and blood lipids in adults with metabolic syndrome: a 6-month randomized controlled trial. Sci Rep. 2024 Oct 16;14(1):24241. doi: 10.1038/s41598-024-75579-8.

  • Norha J, Sjoros T, Garthwaite T, Laine S, Verho T, Saunavaara V, Laitinen K, Houttu N, Hirvonen J, Vaha-Ypya H, Sievanen H, Loyttyniemi E, Vasankari T, Kalliokoski K, Heinonen I. Effects of reducing sedentary behaviour on back pain, paraspinal muscle insulin sensitivity and muscle fat fraction and their associations: a secondary analysis of a 6-month randomised controlled trial. BMJ Open. 2024 Sep 28;14(9):e084305. doi: 10.1136/bmjopen-2024-084305.

  • Sjoros T, Norha J, Johansson R, Laine S, Garthwaite T, Vaha-Ypya H, Loyttyniemi E, Kalliokoski KK, Sievanen H, Vasankari T, Knuuti J, Heinonen IHA. Tiredness after work associates with less leisure-time physical activity. Sci Rep. 2024 Apr 4;14(1):7965. doi: 10.1038/s41598-024-58775-4.

  • Sjoros T, Laine S, Garthwaite T, Vaha-Ypya H, Loyttyniemi E, Koivumaki M, Houttu N, Laitinen K, Kalliokoski KK, Sievanen H, Vasankari T, Knuuti J, Heinonen IHA. Reducing Sedentary Time and Whole-Body Insulin Sensitivity in Metabolic Syndrome: A 6-Month Randomized Controlled Trial. Med Sci Sports Exerc. 2023 Mar 1;55(3):342-353. doi: 10.1249/MSS.0000000000003054. Epub 2022 Oct 13.

  • Norha J, Hautala AJ, Sjoros T, Laine S, Garthwaite T, Knuuti J, Loyttyniemi E, Vaha-Ypya H, Sievanen H, Vasankari T, Heinonen IHA. Standing time and daily proportion of sedentary time are associated with pain-related disability in a one month accelerometer measurement in adults with overweight or obesity. Scand J Pain. 2021 Sep 27;22(2):317-324. doi: 10.1515/sjpain-2021-0108. Print 2022 Apr 26.

  • Sjoros T, Vaha-Ypya H, Laine S, Garthwaite T, Lahesmaa M, Laurila SM, Latva-Rasku A, Savolainen A, Miikkulainen A, Loyttyniemi E, Sievanen H, Kalliokoski KK, Knuuti J, Vasankari T, Heinonen IHA. Both sedentary time and physical activity are associated with cardiometabolic health in overweight adults in a 1 month accelerometer measurement. Sci Rep. 2020 Nov 25;10(1):20578. doi: 10.1038/s41598-020-77637-3.

MeSH Terms

Conditions

Metabolic SyndromeMotor ActivityInsulin ResistanceCardiovascular DiseasesSedentary Behavior

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Study Officials

  • Juhani Knuuti, Professor

    Turku PET Centre, Turku University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the intervention, masking of the participants is not possible. Analyzing of the obtained data will be masked.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A parallel-group randomised controlled trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 24, 2017

First Posted

April 5, 2017

Study Start

April 25, 2017

Primary Completion

February 14, 2020

Study Completion

March 4, 2020

Last Updated

April 8, 2020

Record last verified: 2020-04

Locations