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Trial registered on ANZCTR


Registration number
ACTRN12618001249246
Ethics application status
Approved
Date submitted
10/07/2018
Date registered
24/07/2018
Date last updated
4/06/2019
Date data sharing statement initially provided
4/06/2019
Date results information initially provided
4/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Project GRIT (Growth, Resilience, Insights, Thrive): a pilot intervention study to prevent childhood obesity
Scientific title
Project GRIT (Growth, Resilience, Insights, Thrive): a pilot single-arm intervention study to prevent childhood obesity
Secondary ID [1] 295488 0
None
Universal Trial Number (UTN)
Trial acronym
GRIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
childhood obesity
308757 0
Condition category
Condition code
Diet and Nutrition 307685 307685 0 0
Obesity
Public Health 307686 307686 0 0
Health promotion/education
Metabolic and Endocrine 307687 307687 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants of Project Grit undertake a 12-week program implemented by a multidisciplinary group of qualified health professionals. Once a participant has joined the program, they are provided with a journal, a GRIT t-shirt, a visor, a drink bottle and a heart rate monitor and chest strap. Only the heart rate monitor and chest strap need to be returned at the close of the project.

Heart rate monitoring
During all exercise sessions participants will wear a the A300 Polar Fitness Watch and Activity Tracker heart rate monitor paired to a chest strap. Children and their parents will be trained in the use and interpretation of the heart rate monitor by the WLSA Project GRIT staff, and will be assisted to calculate their maximum heart rate (HRmax), and identify their heart rate zone which is the heart rate zone which achieves the greatest level of fat oxidation (LIPOXmax). The heart rate data obtained from the polar fitness watch during the exercise sessions will be checked after the sessions to determine if the participant has achieved the appropriate hear rate zones during the session.

Exercise sessions
The children will attend three group sessions of high-intensity interval training (HIIT) per week (across the 12 week program), which will last for 30-minutes. The HIIT will begin with a slow run warm up followed by a gentle supervised stretch, and will be finished with an easy 200m walk. The HIIT will involve running fast for short periods with long recovery periods where the participants will be walking and lightly jogging. No exercise equipment will be used. The HIIT sessions will be implemented by a professional Fitness Trainer assisted by qualified supervision staff. There will be staff present for each training session (i.e. 1 staff per 10 children). The following interval sets will be used in the HIIT sessions, with a gradual progression through the weeks:
• 15-seconds high intensity activity: 2.45-minutes recovery at 50-70% HRmax.
• 30-seconds high intensity activity: 4.30-minutes recovery at 50-70% HRmax.
• 1-minute high intensity activity: 4-minutes recovery at 50-70% HRmax.
Attendance logs will be kept at all exercise sessions.

Healthy eating workshops/cooking demonstrations
During the 12-week program, three group workshops will be held which focus on healthy eating and two group workshops will be held for cooking demonstration. These sessions will last for approximately one hour and will be implemented by Accredited Practicing Dietitians. The workshops will be offered in the same small groups that children participate in their HIIT exercise with to build a sense of teamwork, trust and companionship. Participant groups will attend the workshops in either Weeks 1, 5 and 9 or in Weeks 2, 6 and 10. In addition to the three healthy eating workshops, all participants will attend two cooking demonstrations. These will be held in week 1 or 2, and then again in week 10, 11 or 12. In the weeks a group is not participating in a healthy eating workshop, they have workbook activities to complete. The first cooking demonstration will involve basic demonstrations on how to prepare healthy meals and snacks. The second cooking demonstration will involve a guest chef making a recipe created by one of the participants. The participants will not be cooking or involved in food preparation. Attendance logs will be kept at all healthy eating and cooking demonstration sessions.

Emotional freedom workshops
Each participant will attend a single group session within the 12-week program on emotional freedom technique (EFT) run by a Psychologist. The content of the workshop is an EFT (tapping workshop for kids), which is an alternative behaviour technique to self soothe. The group will be broken down into maximum of 12 participants per session. In addition to the EFT workshops, one-on-one sessions with the psychologist will be offered to Project GRIT participants on an as needed basis, reflecting any needs identified during the cognitive assessment with the psychologist at baseline. An attendance log will be kept at the EFT session.
Mindfulness workshop
A psychologist will run a single group session of mindfulness within the second half of the 12-week program. The mindfulness workshop will focus on eating behaviour techniques, and will involve guided eating meditations and discussions. Mindful eating techniques focus on attending physical hunger, satiety, taste, and awareness of cues to eat; it also focuses on the practice of savouring tastes and textures. During the workshop, participants will be offered non-allergenic foods to interact with and consume, such as raisins. An attendance log will be kept at the mindfulness session.
Intervention code [1] 301805 0
Lifestyle
Intervention code [2] 301806 0
Prevention
Intervention code [3] 301809 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306672 0
VO2max - maximal oxygen uptake. The amount of oxygen the body is capable of utilizing in one minute (measure of aerobic capacity). Measured by Ultima CPX metabolic stress testing system.
Timepoint [1] 306672 0
baseline and 12-weeks at end of intervention
Primary outcome [2] 306673 0
FATmax - the exercise intensity at which the maximal rate of fat oxidation achieved during exercise occurs. Measured by Ultima CPX metabolic stress testing system.
Timepoint [2] 306673 0
baseline and 12-weeks at end of intervention
Primary outcome [3] 306674 0
Australian Child and Adolescent Recommended Food Score (ACARFS) total score. Measured by the Australian Child and Adolescent Eating Survey (ACAES), a validated135-item semi-quantitative food frequency questionnaire (FFQ) with a report generated by the University of Newcastle.
Timepoint [3] 306674 0
baseline and 12-weeks at end of intervention
Secondary outcome [1] 349195 0
Fasting, respiratory quotient at rest. Measured by Ultima CPX metabolic stress testing system
Timepoint [1] 349195 0
baseline and 12-weeks at end of intervention
Secondary outcome [2] 349197 0
Substrate oxidation (fat versus carbohydrate) during exercise. Measured by Ultima CPX metabolic stress testing system
Timepoint [2] 349197 0
baseline and 12-weeks at end of intervention
Secondary outcome [3] 349198 0
Resting metabolic rate. Measured by Ultima CPX metabolic stress testing system.
Timepoint [3] 349198 0
Baseline and 12-weeks at end of intervention
Secondary outcome [4] 349199 0
Resting heart rate. Measured by Ultima CPX metabolic stress testing system
Timepoint [4] 349199 0
baseline and 12-weeks at end of intervention
Secondary outcome [5] 349200 0
Waist circumference (cm) via flexible tape measure
Timepoint [5] 349200 0
baseline and 12-weeks at end of intervention
Secondary outcome [6] 349201 0
BMI-for-age - Height (stadiometer) and weight (standing scales) measured and plotted on BMI-for-age growth charts.
Timepoint [6] 349201 0
Baseline and 12-weeks at end of intervention
Secondary outcome [7] 349230 0
Daily energy intake measured by the Australian Child and Adolescent Eating Survey (ACAES), a validated135-item semi-quantitative food frequency questionnaire (FFQ) with a report generated by the University of Newcastle.
Timepoint [7] 349230 0
Baseline and 12-weeks at end of intervention
Secondary outcome [8] 349231 0
Proportion of energy intake from healthy versus discretionary foods measured by the Australian Child and Adolescent Eating Survey (ACAES), a validated135-item semi-quantitative food frequency questionnaire (FFQ) with a report generated by the University of Newcastle.
Timepoint [8] 349231 0
Baseline and 12-weeks at end of intervention
Secondary outcome [9] 349232 0
ACARFS score for each food group, measured by the Australian Child and Adolescent Eating Survey (ACAES), a validated135-item semi-quantitative food frequency questionnaire (FFQ) with a report generated by the University of Newcastle.
Timepoint [9] 349232 0
Baseline and 12-weeks at end of intervention
Secondary outcome [10] 349233 0
Percentage energy contribution from saturated fat measured by the Australian Child and Adolescent Eating Survey (ACAES), a validated135-item semi-quantitative food frequency questionnaire (FFQ) with a report generated by the University of Newcastle.
Timepoint [10] 349233 0
Baseline and 12-weeks at end of intervention
Secondary outcome [11] 349234 0
Fibre intake measured by the Australian Child and Adolescent Eating Survey (ACAES), a validated135-item semi-quantitative food frequency questionnaire (FFQ) with a report generated by the University of Newcastle.
Timepoint [11] 349234 0
Baseline and 12-weeks at end of intervention
Secondary outcome [12] 349235 0
Self-concept, measured by the Way I Feel About Myself Piers-Harris 2 AutoScore Form
Timepoint [12] 349235 0
baseline and 12-weeks at end of intervention
Secondary outcome [13] 349236 0
Adverse events related to High Intensity Interval Training. All adverse events will be recorded using researcher logs. Serious adverse events will be those considered life-threatening, resulting in death, requiring inpatient hospitalisation or prolongation of existing hospitalisation, resulting in persistent or significant disability/capacity, requiring surgical intervention, or is otherwise medically significant. Minor adverse events are those not considered significant, but result in intervention by the allied health or medical team including the treatment of strain, muscular, tendon or joint injury, falls, cuts or skin abrasions, the requirement for prescription physical injury-related medication; or result in significantly and persistent abnormal heart rate, blood pressure or breathing.
Timepoint [13] 349236 0
During exercise sessions of 12-week program.
Secondary outcome [14] 349237 0
Participant satisfaction (child) measured by satisfaction surveys developed specifically for the GRIT project.
Timepoint [14] 349237 0
12-weeks at end of intervention
Secondary outcome [15] 349554 0
Participant satisfaction (parent) measured by satisfaction survey developed specifically for the GRIT project.
Timepoint [15] 349554 0
12-weeks at end of intervention

Eligibility
Key inclusion criteria
The following inclusion criteria will apply:
Child aged 9 (but turning 10 in 2018) – 15 years.
Parent(s) and child able to commit to a 12-week program with at least 80% attendance of all Project GRIT sessions.
Inactive child (self-reported).
Consent of supportive parent or guardian to help implement lifestyle changes.
Approval by child's usual GP for the child to participate in intense exercise and VO2max testing.
Minimum age
9 Years
Maximum age
15 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The following exclusion criteria will apply:
Known diagnosis of learning disorder and/or medical condition with which the staff involved or research team cannot provide sufficient support for, including: Attention Deficit Hyperactivity Disorder, Autism, Asperger Syndrome, Tourette Syndrome or Bipolar Disorder.
Known diagnosis with a medical condition which is a contraindication for participation in high-intensity exercise including: hypertension as defined by systolic and/or diastolic blood pressure equal to or greater than the 95th percentile measured upon three or more occasions; history or evidence of cardiac abnormalities or family history of hypertrophic obstructive cardiomyopathy; hypercholesterolemia; family history of hypertrophic obstructive cardiomyopathy; chronic disease including but not limited to kidney disease, chronic asthma, diabetes (type I or II); orthopaedic or neurological disorder which limits physical activity; pulmonary disease.
Current smoker.
Use of steroid medications.

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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
No sample size calculation was performed as this represents a pilot study.
An 80% attendance of all Project GRIT sessions is required of study participants, and those with <80% will be excluded from the data analysis.
Participant characteristics and outcomes will be reported using descriptive statistics. Changes within each group for the primary and secondary outcomes from baseline to completion will be tested using chi-square or paired t-tests as appropriate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 23309 0
4227 - Varsity Lakes

Funding & Sponsors
Funding source category [1] 300075 0
Commercial sector/Industry
Name [1] 300075 0
Weight Loss Solutions Australia
Address [1] 300075 0
Suite 3, Podium Level Lakeside 1, 1 Lake Orr Dr, Varsity Lakes QLD 4227
Country [1] 300075 0
Australia
Primary sponsor type
University
Name
Bond University
Address
14 University Dr, Robina QLD 4226
Country
Australia
Secondary sponsor category [1] 299473 0
Commercial sector/Industry
Name [1] 299473 0
Weight Loss Solutions Australia
Address [1] 299473 0
Suite 3, Podium Level Lakeside 1, 1 Lake Orr Dr, Varsity Lakes QLD 4227
Country [1] 299473 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300922 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 300922 0
Research Services
Building 1C, Level 4
Bond University QLD 4229
Ethics committee country [1] 300922 0
Australia
Date submitted for ethics approval [1] 300922 0
10/05/2018
Approval date [1] 300922 0
18/06/2018
Ethics approval number [1] 300922 0
SM02967

Summary
Brief summary
Project GRIT (Growth, Resilience, Insights, Thrive) is a single arm pilot intervention study for children. The program is 12-weeks in length and involves exercise (high intensity interval training), healthy eating and psychological intervention (mindfulness and emotional freedom techniques) for children. The key research question of Project GRIT is: what is the effectiveness of a multidisciplinary intervention involving small-group exercise training and dietary education on metabolic fitness, body composition, cognitive performance, and diet quality in sedentary children aged 9 – 15 years living on the Gold Coast, Australia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85290 0
Prof Liz Isenring
Address 85290 0
Bond Institute of Health and Sport, 2 Promethean Way, Robina, Queensland, 4226, Australia
Country 85290 0
Australia
Phone 85290 0
+61 7 5595 3337
Fax 85290 0
Email 85290 0
lisenrin@bond.edu.au
Contact person for public queries
Name 85291 0
Dr Hannah Mayr
Address 85291 0
Bond Institute of Health and Sport, 2 Promethean Way, Robina, Queensland, 4226, Australia
Country 85291 0
Australia
Phone 85291 0
+61 0432076263
Fax 85291 0
Email 85291 0
hmayr@bond.edu.au
Contact person for scientific queries
Name 85292 0
Dr Hannah Mayr
Address 85292 0
Bond Institute of Health and Sport, 2 Promethean Way, Robina, Queensland, 4226, Australia
Country 85292 0
Australia
Phone 85292 0
+61 0432076263
Fax 85292 0
Email 85292 0
hmayr@bond.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical approval has not been granted and participants (who are children) did not provide consent for data to be made available.
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 2069 0
Ethical approval
Citation [1] 2069 0
Link [1] 2069 0
Email [1] 2069 0
Other [1] 2069 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary