MOReS Freestyle Libre Validation Study

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

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-28

Study Completion Date

2024-09-30

Brief Summary

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

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.

Related Clinical Trials

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

Can Structured Education Promote Physical Activity in Those Identified With an Increased Risk of Developing Diabetes

NCT00566319

Prediabetic State

COMPLETED NA

MHealth Biometrics for Young People with Diabetes

NCT04868851

Diabetes

COMPLETED NA

Evaluation of Exercise Application Technology in Adolescents

NCT05720377

Type 2 Diabetes PreDiabetes Obesity

WITHDRAWN NA

Physical Activity Monitoring Paediatric Type 1 Diabetes

NCT03144869

Diabetes Mellitus, Type 1

COMPLETED NA

SIT LESS 3: The Effect of Low Intensity Physical Activity on Insulin Sensitivity, Mood and Cognitive Performance

NCT02394249

Overweight Obesity

COMPLETED NA

Detailed Description

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

Cross over randomised exposure response experimental study in 10 healthy children and adolescents, to measure the effects of interrupting prolonged sitting with brief standing physical activity interventions on their physical and cognitive performance, mobility, health and wellbeing. The study will assess the extent of the immediate and short-term effects of interrupting sitting with brief moderate-vigorous physical activity (MVPA) breaks compared to a sitting only condition.

Dietary analysis and metabolic and cognitive tests after acute exercise will be performed on the participants to compare the FreeStyle Libre responses between those with and without disabilities.

Conditions

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

Blood Glucose Executive Function Cognitive Change

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomised cross over design. Participants act as own controls.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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

20 minutes MVPA

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.

Group Type EXPERIMENTAL

Exposure

Intervention Type OTHER

Participants randomised to one of the three exposures

4 x 5 mins MVPA

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.

Group Type EXPERIMENTAL

Exposure

Intervention Type OTHER

Participants randomised to one of the three exposures

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

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

Group Type EXPERIMENTAL

Exposure

Intervention Type OTHER

Participants randomised to one of the three exposures

Interventions

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

Exposure

Participants randomised to one of the three exposures

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* 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)

Exclusion Criteria

* 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

Minimum Eligible Age

9 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes