Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001145594
Ethics application status
Approved
Date submitted
20/10/2015
Date registered
28/10/2015
Date last updated
9/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The Eat And Sit Youth (EASY) study: the role of diet in the relationship between sitting and postprandial glucose in adolescents
Scientific title
The role of diet in the relationship between prolonged and interrupted sitting with postprandial glucose responses in adolescents
Secondary ID [1] 287700 0
None
Universal Trial Number (UTN)
None
Trial acronym
EASY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impaired glucose responses 296534 0
Condition category
Condition code
Diet and Nutrition 296798 296798 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adolescents, aged 14-17 years from Melbourne suburbs, will participate in a four-treatment, acute crossover trial in a laboratory setting. The four trial conditions involve: 1) uninterrupted sitting for 6h and consumption of two ‘healthy’ meals (at 0h and 3h; consistent for each condition); 2) sitting for 6 hours with 2-min interruptions every 18 minutes and consumption of two ‘healthy’ meals; 3) uninterrupted sitting for 6h and consumption of two ‘unhealthy’ meals; and 4) sitting for 6 hours with 2-min interruptions sitting every 18 minutes and consumption of two ‘unhealthy’ meals.
Both the healthy and unhealthy meal contains the same macronutrient content (e.g. 55% carbohydrates, 30% from fat and 15% from protein). However, the ‘healthy’ meal is 25% of the daily recommended energy intake (2,802kj) and follows the dietary guidelines for healthy eating (e.g. contains whole grains, lean meat, is low in sodium, high in fibre etc). Whereas the ‘unhealthy’ meal contains 1.5 times more kilojoules (4,203kj) and does not follow the guidelines (e.g. low in fibre, high in sodium, refined carbohydrates etc). Participants will be asked to consume the meals within 20 minutes, and any food or drink left over will be recorded and accounted for in the analyses.
Each condition will be performed on separate days with a rest day/washout period in between conditions. Prior to beginning, participants will be fitted with a Continuous Glucose Monitoring (CGM) system to monitor interstitial blood glucose and wear an accelerometer and inclinometer to objectively measure their sedentary and sitting time, respectively, during each condition. The interruptions during condition 2 and 4 will involve two minutes of simple exercises such as body squats, calf raises, gluteal contractions, and step-ups. During all four conditions, all participants will be supervised by research staff to ensure compliance to the protocol.
Intervention code [1] 293093 0
Behaviour
Intervention code [2] 293118 0
Lifestyle
Comparator / control treatment
The healthy meal with no exercise break will act as the control
Control group
Active

Outcomes
Primary outcome [1] 296398 0
Postprandial glucose is the primary outcome and will be measure busing a continuous glucose monitoring (CGM) system.
Timepoint [1] 296398 0
Every 5 minutes from 0 to 6 hours
Secondary outcome [1] 318430 0
Appetite
Timepoint [1] 318430 0
Before and after each of the four conditions
Secondary outcome [2] 318431 0
Fatigue
Timepoint [2] 318431 0
Before and after each of the four conditions

Eligibility
Key inclusion criteria
Adolescents aged between 14- 17 years
Living in Melbourne, Australia
Minimum age
14 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) On any lipid or glucose lowering medications that may affect glucose and lipid metabolism (e.g. anti-depressants, etc); 2) Chronic (>twice/week) use of prescribed medication that can effect glucose metabolism (e.g. anti-depressants and antipsychotic); 3) Chronic (>twice/week) use of nonsteroidal anti-inflammatory drugs (e.g. aspirin, ibuprofen and naproxen): 4) Use of asthma medicines; 5) Daily antioxidant supplementation; 6) Diagnosed type 2 diabetes, glucose intolerance, cardiovascular disease, hypertension, and/or an abnormal lipid profile; 7) Diet allergies to gluten, lactose or fructose, nuts, and if vegetarian or vegan; and 8) BMI >35kg/m2

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is an exploratory pilot study, a sample of 10 participants will be recruited. A previous repeated-measures study that took place in an office environment included 10 adult participants and were able to compare the associations between blood glucose responses to sitting and standing using accelerometry. The area under the curve (AUC) will be calculated for the cumulative measurement of glucose against sitting time post 3 hours of the main test meals. Prism or graph pad will be used to plot the AUC in blood glucose units (x axis) against the minutes spent sitting (y axis) using regression analyses. Generalised estimating equations with repeated measures will be used to evaluate the different effects sitting and interrupted sitting has on glucose post 3-hours after the main meals. All models will adjust for the covariates such as age, BMI, waist cicumference and pubertal status.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/11/2015
Actual
2/11/2015
Date of last participant enrolment
Anticipated
30/01/2016
Actual
18/01/2016
Date of last data collection
Anticipated
Actual
30/01/2016
Sample size
Target
10
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 10672 0
3125 - Burwood
Recruitment postcode(s) [2] 10673 0
3152 - Knox City Centre
Recruitment postcode(s) [3] 10674 0
3149 - Mount Waverley
Recruitment postcode(s) [4] 10675 0
3128 - Box Hill
Recruitment postcode(s) [5] 10676 0
3148 - Chadstone

Funding & Sponsors
Funding source category [1] 292254 0
Government body
Name [1] 292254 0
National Health and Medical Research Council, Centre of Research Excellence
Country [1] 292254 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway, Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 290929 0
None
Name [1] 290929 0
Address [1] 290929 0
Country [1] 290929 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293717 0
Deakin University Human Research Ethics Committee (EC00213)
Ethics committee address [1] 293717 0
Ethics committee country [1] 293717 0
Australia
Date submitted for ethics approval [1] 293717 0
20/02/2015
Approval date [1] 293717 0
02/04/2015
Ethics approval number [1] 293717 0
2015-039

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61082 0
Prof Jo Salmon
Address 61082 0
Centre for Physical Activity and Nutrition Research (C-PAN)
School of Exercise and Nutrition Sciences, Faculty of Health
Deakin University, Melbourne Burwood Campus
221 Burwood Highway
Burwood, VIC 3125
Country 61082 0
Australia
Phone 61082 0
(+61)3 9251 7254
Fax 61082 0
(+61)3 9244 6017
Email 61082 0
[email protected]
Contact person for public queries
Name 61083 0
Elly Fletcher
Address 61083 0
Centre for Physical Activity and Nutrition Research (C-PAN)
School of Exercise and Nutrition Sciences, Faculty of Health
Deakin University, Melbourne Burwood Campus
221 Burwood Highway
Burwood, VIC 3125
Country 61083 0
Australia
Phone 61083 0
(+61)3 9251 7262
Fax 61083 0
(+61)3 9244 6017
Email 61083 0
[email protected]
Contact person for scientific queries
Name 61084 0
Elly Fletcher
Address 61084 0
Centre for Physical Activity and Nutrition Research (C-PAN)
School of Exercise and Nutrition Sciences, Faculty of Health
Deakin University, Melbourne Burwood Campus
221 Burwood Highway
Burwood, VIC 3125
Country 61084 0
Australia
Phone 61084 0
(+61)3 9251 7262
Fax 61084 0
(+61)3 9244 6017
Email 61084 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of breaking up sitting on adolescents' postprandial glucose after consuming meals varying in energy: a cross-over randomised trial.2018https://dx.doi.org/10.1016/j.jsams.2017.06.002
N.B. These documents automatically identified may not have been verified by the study sponsor.