Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001064695
Ethics application status
Approved
Date submitted
1/09/2014
Date registered
3/10/2014
Date last updated
3/10/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Stand Up for Health Project: Using a ‘whole room calorimeter’ to assess the effects of sitting on adolescents health
Scientific title
In adolescents aged 12-15 years, does a ‘reduced sitting’ school day, compared to a typical school day improve energy expenditure, cardio-metabolic health and cognitive outcomes?
Secondary ID [1] 285270 0
nil
Universal Trial Number (UTN)
U1111-1160-5321
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and obesity 292918 0
Cardio-metabolic health indicators 292919 0
Sitting time 292920 0
Cognition 292923 0
Condition category
Condition code
Cardiovascular 293206 293206 0 0
Normal development and function of the cardiovascular system
Public Health 293207 293207 0 0
Health promotion/education
Diet and Nutrition 293286 293286 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adolescents will make three visits to the whole room calorimeter:
Visit 1 – Initial familiarization with calorimeter and a discussion with parents and adolescents to start the process of consent. Parents and adolescents will be required to sign two consent forms; one for the study and a second if they consent to have their blood taken as part of the study.
Activity monitors:
Before entering the calorimeter, adolescents will be fitted with 7 activity monitors on 4 body sites. The adolescent will wear three GENEActiv monitors, three Actigraphs and one SenseWear Mini armband. distribution around the body, these devices have not inhibited movement during the activity protocol in our validation study in preschool children. The SenseWear Mini arm band is required to be worn for an additional 48 hours after Visit 2 and 3 of the calorimeter room. The participant and parent/guardian will be asked fill in an activity monitor log noting when this monitor is worn and not worn.
Video – taping and direct observation will occur during Visits 2 and 3. This will be used to i) confirm compliance with protocol, ii) to code postures/activity types (e.g., sitting, standing, walking) against newly developed activity monitor data analysis approaches, so validation can occur.
The order of visits 2 and 3 will be randomly allocated to each participant to minimize any ordering effect. As such, for some adolescents, they will complete the modified school day prior to the typical school day.
There are two calorimeter rooms available at UOW. Both rooms will be used in this study.
Visit 2 – (Simulated typical school day: 240mins of sitting). Participants will arrive 20 minutes prior to entering the calorimeter at 8am having fasted overnight. Participants who consent to have blood taken will have blood (total 20ml) drawn by an accredited phlebotomist prior to entering and immediately upon leaving the calorimeter to assess beneficial effect on total fatty acids, IL-6, blood glucose, total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), insulin and apolipoproteins A-1 and B-100. Trained personnel at the Illawarra Health and Medical Research Institute (IHMRI) will conduct the blood collection. In addition participants will have their height, weight (BMI), waist circumference, body fat and blood pressure measured.
The participant will then be taken to the calorimeter room to begin their “Typical School Day”. A standard breakfast will be consumed half an hour after the participant has entered the chamber to allow collection of Basal Metabolic Rate (BMR) data beforehand. A standard lunch will be provided 2.5 hours after breakfast (3 hours prior to final blood collection). Participants will then spend 240 minutes out of 6 hours sitting, undertaking tasks that they normally would as part of a typical school day.
Visit 3 – (Simulated modified school day- approx 50% less sitting time equating to 117 mins). This will be identical to Visit 2 except that participants will sit for 50% less time (120 minutes) and replace this with 50% more time spent in light-intensity activity such as standing and light moving (e.g., shuffling, slow walking.
Visit 2 and 3 Height and weight, body fat, waist circumference and blood pressure will be conducted prior to entering and immediately upon leaving the calorimeter at both Visits 2 and 3. While the participants are in the calorimeter they will complete a test of executive function will be measured using the Figural Intersections Task (a measure of working memory and attentional capacity).
To understand if participants compensate for sitting less and engaging in more light-intensity PA by being less active afterwards, we will ask participants to wear a sensewear mini arm band for 48 hours after Visits 2 and 3. The Sensewear Mini will be used to assess Energy Expenditure over the 48 hour period immediately following Visits 2 and 3. Participants will also be asked to fill in a one-page log that indicates when the accelerometer was worn or not worn (e.g. removed for showering).
To assess whether participants compensate for less sitting by increasing their energy intake, we will ask participants to complete a 24hr food diary after Visit 2 and 3 to the calorimeter. This will allow the estimation of total intake of food, beverages, food energy, nutrients and non-nutrient food components consumed.
Intervention code [1] 290149 0
Lifestyle
Intervention code [2] 290150 0
Behaviour
Intervention code [3] 290151 0
Prevention
Comparator / control treatment
Crossover design. The minimum duration between visits is 48 hours. Participants will spend one day in the Whole Room Calorimeter undertaking activities that mimic a typical school day, within one week they will return to the calorimeter to mimic a reduced sitting school day (50% reduction in sedentary time).
Control group
Active

Outcomes
Primary outcome [1] 293075 0
The impact of a reduced sitting school day on adolescent energy expenditure as measured by the whole room calorimeter.
Timepoint [1] 293075 0
Crossover design, individual is their own control. Pre- measures taken during Visit 2 and 3; prior to entering the calorimeter followed by a 6 hour period in the calorimeter and then post measures at the end of each day. There must be at least a 48 hour period between each visit. Both days will be assessed within one week of the first day of data collection. Data collection will be in the July and September school holidays in 2014. Participant data will be collected within the one school holiday period.
Primary outcome [2] 293076 0
Cognition as assessed by the Figural Intersections Task (FIT)
Timepoint [2] 293076 0
Crossover design, individual is their own control. Pre and post measures (for visits 2 and 3) immediately upon entering the calorimeter and just before leaving the calorimeter, on each day; both days assessed within one week of each other. Data collection will be in the July and September school holidays in 2014. Participant data will be collected within the one school holiday period.
Primary outcome [3] 293126 0
The impact of a reduced sitting school day on adolescent cardio-metabollic outcomes, as assessed by blood analysis, these include:Fasted glucose, Total cholesterol,Triglycerides, High-density lipoprotein (HDL), Total cholesterol/HDL ratio, Low-density lipoprotein (LDL), Non high-density lipoprotein cholesterol HDLC, Apolipoprotein A1, Apolipoprotein B, S-Insulin and IL6
Timepoint [3] 293126 0
Crossover design, individual is their own control. Pre and post measures immediately before entering the calorimeter for a 6 hour period and upon leaving the calorimeter, on each day for visit 2 and 3. Both days assessed within one week of each other. Data collection will be in the July and September school holidays in 2014. Participant data will be collected within the one school holiday period.
Secondary outcome [1] 310292 0
Descriptive data age, school year, height, weight, BMI, Blood pressure and body fat. Body Fat is assessed by Tanita body fat scales.
Timepoint [1] 310292 0
Crossover design, individual is their own control. All descriptive data will be collected prior to them entering the calorimeter during visit 2 and 3. and only blood pressure will be assessed 6 hours later after leaving the calorimeter during visit 2 adn 3. both days assessed within one week of each other. Data collection will be in the July and September school holidays in 2014. Participant data will be collected within the one school holiday period.

Eligibility
Key inclusion criteria
Minimum age 12, maximum age 15- healthy participants
Minimum age
12 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participant is claustrophobic
Participant has a medical condition or illness that will influence the outcome of energy expenditure or cardio-metabolic indicators
Participant is not in the age range 12-15 years

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Adolescents will be invited to participate via advertisements in high school newsletters and University staff email. After parents have contacted the study team, potential participants will undergo basic screening (re: exclusion criteria) If the adolescent is eligible an information sheet will be sent to them. Once it is confirmed that their child is interested in participating in the study an appointment will be arranged for them to visit the whole room calorimeter at the University of Wollongong. Adolescents who agree to participate in the study will be randomised to a ‘typical school day’ or ‘reduced sitting day’ in the calorimeter using a randomised sequence spread sheet. Whichever day the adolescent participates in the first instance, they will undergo the protocol of the other day on their next visit.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants were allocated to either randomly allocated to either the control or intervention day using a randomised sequence spread sheet. The sequence used was developed by the statistician Jerry Dallal Chief, Biostatistics Unit USDA Jean Mayer Human Nutrition Research Center on Aging
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
Based on the average weight of a 13 year old with an elevated BMI, and the EE values for sedentary and light – intensity PA from a previous whole room calorimeter study in this age group (Puyau et al. 2002), we expect to see a difference of 162 kcals between a typical and modified school day. The sample size would need to be 20 adolescents to provide at least 90% power to detect these differences, based on a SD of 100 kcals.

Analyses will be conducted in SPSS or STATA. To quantify the differences between the two conditions (‘typical or reduced sitting school days’), generalised estimating equations will be adjusted for covariates such as BMI, age, sex, and body composition. This will also account for the paired nature of the data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/06/2014
Actual
19/07/2014
Date of last participant enrolment
Anticipated
25/10/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 289890 0
University
Name [1] 289890 0
A University of Wollongong Small Grant funds this study
Country [1] 289890 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
University of Wollongong
Wollongong NSW 2522
Country
Australia
Secondary sponsor category [1] 288571 0
University
Name [1] 288571 0
Early Start Research Institute at the University of Wollongong
Address [1] 288571 0
University of Wollongong
Wollongong NSW 2522
Country [1] 288571 0
Australia
Secondary sponsor category [2] 288572 0
Individual
Name [2] 288572 0
Dr Dylan Cliff
Address [2] 288572 0
University of Wollongong
Wollongong NSW 2522
Country [2] 288572 0
Australia
Secondary sponsor category [3] 288573 0
Individual
Name [3] 288573 0
Dr Bridget Kelly
Address [3] 288573 0
University of Wollongong
Wollongong NSW 2522
Country [3] 288573 0
Australia
Secondary sponsor category [4] 288574 0
Individual
Name [4] 288574 0
Professor Jo Salmon
Address [4] 288574 0
Deakin University
Melbourne Burwood Campus, 221 Burwood Highway, Burwood, VIC 3125
Country [4] 288574 0
Australia
Secondary sponsor category [5] 288575 0
Individual
Name [5] 288575 0
Professor Stewart Trost
Address [5] 288575 0
Queensland University of Technology,
2 George St
Brisbane, 4000
Country [5] 288575 0
Australia
Secondary sponsor category [6] 288679 0
University
Name [6] 288679 0
Illawarra Health and Medical Research Institute
Address [6] 288679 0
University of Wollongong
Wollongong NSW 2522
Country [6] 288679 0
Australia
Other collaborator category [1] 278145 0
Individual
Name [1] 278145 0
Prof Tony Okely
Address [1] 278145 0
University of Wollongong
Wollongong NSW 2522
Country [1] 278145 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291613 0
Health and Medical Science Human Research Ethics Committee
Ethics committee address [1] 291613 0
Ethics committee country [1] 291613 0
Australia
Date submitted for ethics approval [1] 291613 0
Approval date [1] 291613 0
12/05/2014
Ethics approval number [1] 291613 0
HE 14/069

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

Contacts
Principal investigator
Name 51150 0
Dr Anne-Maree Parrish
Address 51150 0
Dr Anne-Maree Parrish
School of Health and Society
Faculty of Social Sciences
University of Wollongong NSW 2522
Country 51150 0
Australia
Phone 51150 0
+61 2 4221 5098
Fax 51150 0
+ 61 2 4221 5945
Email 51150 0
[email protected]
Contact person for public queries
Name 51151 0
Anne-Maree Parrish
Address 51151 0
Dr Anne-Maree Parrish
School of Health and Society
Faculty of Social Sciences
University of Wollongong NSW 2522
Country 51151 0
Australia
Phone 51151 0
+61 2 4221 5098
Fax 51151 0
+ 61 2 4221 5945
Email 51151 0
[email protected]
Contact person for scientific queries
Name 51152 0
Anne-Maree Parrish
Address 51152 0
Dr Anne-Maree Parrish
School of Health and Society
Faculty of Social Sciences
University of Wollongong NSW 2522
Country 51152 0
Australia
Phone 51152 0
+61 2 4221 5098
Fax 51152 0
+ 61 2 4221 5945
Email 51152 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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