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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]

None

Universal Trial Number (UTN)

None

Trial acronym

EASY

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Impaired glucose responses

Condition category

Condition code

Diet and Nutrition

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]

Behaviour

Intervention code [2]

Lifestyle

Comparator / control treatment

The healthy meal with no exercise break will act as the control

Control group

Active

Outcomes

Primary outcome [1]

Postprandial glucose is the primary outcome and will be measure busing a continuous glucose monitoring (CGM) system.

Timepoint [1]

Every 5 minutes from 0 to 6 hours

Secondary outcome [1]

Appetite

Timepoint [1]

Before and after each of the four conditions

Secondary outcome [2]

Fatigue

Timepoint [2]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3125 - Burwood

Recruitment postcode(s) [2]

3152 - Knox City Centre

Recruitment postcode(s) [3]

3149 - Mount Waverley

Recruitment postcode(s) [4]

3128 - Box Hill

Recruitment postcode(s) [5]

3148 - Chadstone

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council, Centre of Research Excellence

Address [1]

GHD Building Level 1, 16 Marcus Clarke St, Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

Deakin University

Address

221 Burwood Highway, Burwood VIC 3125

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Deakin University Human Research Ethics Committee (EC00213)

Ethics committee address [1]

221 Burwood Highway, Burwood, VIC 3125

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/02/2015

Approval date [1]

02/04/2015

Ethics approval number [1]

2015-039

Summary

Brief summary

The purpose of this study is to understand how different foods can affect blood glucose responses when a young person sits for a long period of time and when that sitting is interrupted with light exercise breaks. We hypothesise that the glucose responses will be minimised when healthier foods are eaten and when the sitting is interrupted by light exercise breaks.

Trial website

http://www.deakin.edu.au/research/cpan/participate-in-our-studies

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Jo Salmon

Address

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

Australia

Phone

(+61)3 9251 7254

Fax

(+61)3 9244 6017

jo.salmon@deakin.edu.au

Contact person for public queries

Name

Elly Fletcher

Address

Country

Australia

Phone

(+61)3 9251 7262

Fax

(+61)3 9244 6017

elly.fletcher@deakin.edu.au

Contact person for scientific queries

Name

Elly Fletcher

Address

Country

Australia

Phone

(+61)3 9251 7262

Fax

(+61)3 9244 6017

elly.fletcher@deakin.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Effects of breaking up sitting on adolescents' postprandial glucose after consuming meals varying in energy: a cross-over randomised trial.	2018	https://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.

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Documents added manually

Documents added automatically