MOReS Freestyle Libre Validation Study

NCT04989712 | Unknown

• 1 other identifier: LGHC072021
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

To measure the effects of interrupting prolonged sitting with brief standing physical activity interventions on physical and cognitive performance, health and wellbeing in young people.

Conditions

Blood Glucose; Executive Function; Cognitive Change

Keywords

MVPA; Glucose; Cognition; Children; Adolescents

Outcome Measures

Primary Outcomes (2)

• Executive Functioning - Eriksen Flanker Task

  The main outcome will be change in executive functioning from the start to the end of the session using the Eriksen Flanker Task. The test measures selective attention and executive control and measures speed (milliseconds) and accuracy (number of responses correct). This will be performed before the oral glucose tolerance test and again at the end of each session.

  Maximum of two weeks

• Working Memory - WISC Digit Span

  Wechsler Intelligence Scale for Children (WISC) Digit Span will test attention and working memory. The total score is calculated by the number of correct responses. This will be performed before the oral glucose tolerance test and again at the end of each session.

  Maximum of two weeks

Secondary Outcomes (1)

• Oral Glucose Tolerance Test (OGTT)

  Maximum of two weeks

Study Arms (3)

20 minutes MVPA

EXPERIMENTAL

20 minutes of moderate to vigorous exercise at 50-80% maximum heart rate to be performed on a cycle ergometer 40 minutes from the start of the testing session following consumption of a glucose solution at 0 mins. Glucose readings from the FreeStyle Libre to be taken at 0 mins, 30 mins, 60 mins, 90 mins and 120 mins. Cognitive tests to be carried out before the glucose solution is administered at 0 mins and at the 120 min point.

Other: Exposure

4 x 5 mins MVPA

EXPERIMENTAL

4 bouts of 5 minutes of moderate to vigorous exercise at 50-80% maximum heart rate to be performed on a cycle ergometer 30 minutes from the start of the testing session and repeated at 60 mins, 90 mins and 120 mins following consumption of a glucose solution at 0 mins. Glucose readings from the FreeStyle Libre to be taken at 0 mins, 30 mins, 60 mins, 90 mins and 120 mins. Cognitive tests to be carried out before the glucose solution is administered at 0 mins and at the 120 min point.

Other: Exposure

Uninterrupted sitting - No exercise, sitting session (control).

EXPERIMENTAL

A sitting only exposure, glucose solution to be consumed at 0 mins.Glucose readings from the FreeStyle Libre to be taken at 0 mins, 30 mins, 60 mins, 90 mins and 120 mins. Cognitive tests to be carried out before the glucose solution is administered at 0 mins and at the 120 min point

Other: Exposure

Interventions

Exposure OTHER

Participants randomised to one of the three exposures

20 minutes MVPA; 4 x 5 mins MVPA; Uninterrupted sitting - No exercise, sitting session (control).

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Young people aged 9-18 years old
• No significant current or previous medical history
• Are able to participate safely in the study's assessments and brief interrupted sitting moderate to vigorous physical activity (MVPA)

You may not qualify if:

• Those with uncontrolled epilepsy/seizures (stable epilepsy/on medication \> 12 weeks)
• Those who have Type 1 and Type 2 diabetes or other glucose intolerance or on medication for such conditions
• Those who experience contraindications to physical training
• Those who are on any form of steroids, anti-anxiety/depression drugs, birth control, beta-blockers, statin, adrenaline, HIV or Hepatitis C medications (these medications can affect the readings during the oral glucose tolerance test)
• Those with known allergies to plasters

Sponsors & Collaborators

• Oxford Brookes University: lead

Study Sites (1)

Oxford Brookes University

Oxford, Oxfordshire, OX3 0BP, United Kingdom

RECRUITING

Study Officials

• Helen Dawes, PhD

  Oxford Brookes University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shelly Coe, PhD

CONTACT

+441865483839; scoe@brookes.ac.uk

Jo Cossington, BSc

CONTACT

jcossington@brookes.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Model Details: Randomised cross over design. Participants act as own controls.

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: August 4, 2021
• Study Start: October 28, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

GB (1)