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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

2/07/2021

Date data sharing statement initially provided

4/06/2019

Date results 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]

None

Universal Trial Number (UTN)

Trial acronym

GRIT

Linked study record

Health condition

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

childhood obesity

Condition category

Condition code

Diet and Nutrition

Obesity

Public Health

Health promotion/education

Metabolic and Endocrine

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]

Lifestyle

Intervention code [2]

Prevention

Intervention code [3]

Behaviour

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

baseline and 12-weeks at end of intervention

Primary outcome [2]

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]

baseline and 12-weeks at end of intervention

Primary outcome [3]

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]

baseline and 12-weeks at end of intervention

Secondary outcome [1]

Fasting, respiratory quotient at rest. Measured by Ultima CPX metabolic stress testing system

Timepoint [1]

baseline and 12-weeks at end of intervention

Secondary outcome [2]

Substrate oxidation (fat versus carbohydrate) during exercise. Measured by Ultima CPX metabolic stress testing system

Timepoint [2]

baseline and 12-weeks at end of intervention

Secondary outcome [3]

Resting metabolic rate. Measured by Ultima CPX metabolic stress testing system.

Timepoint [3]

Baseline and 12-weeks at end of intervention

Secondary outcome [4]

Resting heart rate. Measured by Ultima CPX metabolic stress testing system

Timepoint [4]

baseline and 12-weeks at end of intervention

Secondary outcome [5]

Waist circumference (cm) via flexible tape measure

Timepoint [5]

baseline and 12-weeks at end of intervention

Secondary outcome [6]

BMI-for-age - Height (stadiometer) and weight (standing scales) measured and plotted on BMI-for-age growth charts.

Timepoint [6]

Baseline and 12-weeks at end of intervention

Secondary outcome [7]

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]

Baseline and 12-weeks at end of intervention

Secondary outcome [8]

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]

Baseline and 12-weeks at end of intervention

Secondary outcome [9]

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]

Baseline and 12-weeks at end of intervention

Secondary outcome [10]

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]

Baseline and 12-weeks at end of intervention

Secondary outcome [11]

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]

Baseline and 12-weeks at end of intervention

Secondary outcome [12]

Self-concept, measured by the Way I Feel About Myself Piers-Harris 2 AutoScore Form

Timepoint [12]

baseline and 12-weeks at end of intervention

Secondary outcome [13]

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]

During exercise sessions of 12-week program.

Secondary outcome [14]

Participant satisfaction (child) measured by satisfaction surveys developed specifically for the GRIT project.

Timepoint [14]

12-weeks at end of intervention

Secondary outcome [15]

Participant satisfaction (parent) measured by satisfaction survey developed specifically for the GRIT project.

Timepoint [15]

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

Sex

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

23/06/2018

Date of last participant enrolment

Anticipated

Actual

18/07/2018

Date of last data collection

Anticipated

18/10/2018

Actual

22/10/2018

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4227 - Varsity Lakes

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Weight Loss Solutions Australia

Address [1]

Suite 3, Podium Level Lakeside 1, 1 Lake Orr Dr, Varsity Lakes QLD 4227

Country [1]

Australia

Primary sponsor type

University

Name

Bond University

Address

14 University Dr, Robina QLD 4226

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Weight Loss Solutions Australia

Address [1]

Suite 3, Podium Level Lakeside 1, 1 Lake Orr Dr, Varsity Lakes QLD 4227

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bond University Human Research Ethics Committee

Ethics committee address [1]

Research Services
Building 1C, Level 4
Bond University QLD 4229

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/05/2018

Approval date [1]

18/06/2018

Ethics approval number [1]

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

Prof Liz Isenring

Address

Bond Institute of Health and Sport, 2 Promethean Way, Robina, Queensland, 4226, Australia

Country

Australia

Phone

+61 7 5595 3337

Fax

[email protected]

Contact person for public queries

Name

Hannah Mayr

Address

Bond Institute of Health and Sport, 2 Promethean Way, Robina, Queensland, 4226, Australia

Country

Australia

Phone

+61 0432076263

Fax

[email protected]

Contact person for scientific queries

Name

Hannah Mayr

Address

Bond Institute of Health and Sport, 2 Promethean Way, Robina, Queensland, 4226, Australia

Country

Australia

Phone

+61 0432076263

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
2069	Ethical approval					375558-(Uploaded-13-05-2019-10-48-41)-Study-related document.pdf

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Multidisciplinary lifestyle intervention in children and adolescents - Results of the project GRIT (Growth, Resilience, Insights, Thrive) pilot study.	2020	https://dx.doi.org/10.1186/s12887-020-02069-x

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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