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Trial registered on ANZCTR


Registration number
ACTRN12616000375459
Ethics application status
Approved
Date submitted
18/03/2016
Date registered
23/03/2016
Date last updated
23/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The SHAKE IT pilot study: Shakes and meal replacements to Help children and Adolescents Kick-start healthy Eating In Type 2 diabetes
Scientific title
Effectiveness and feasibility of a very low energy diet to ameliorate the metabolic abnormalities underlying type 2 diabetes in children and adolescents: a pilot study
Secondary ID [1] 288796 0
None
Universal Trial Number (UTN)
Trial acronym
SHAKE IT:
Shakes and meal replacements to Help children and Adolescents Kick-start healthy Eating In Type 2 diabetes
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 298062 0
Condition category
Condition code
Metabolic and Endocrine 298223 298223 0 0
Diabetes
Diet and Nutrition 298224 298224 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a pilot study. Children and adolescents aged 7-18 years with T2D will be recruited to the study and will follow a very low energy diet intervention (< 800 kcal/day diet consisting primarily of meal replacements) for 8 weeks. At baseline, participants will be provided with a diet information booklet describing the diet they will follow, the study timeline and the possible effects of ketosis which they may experience. During the 8 week intervention, participants will attend The Children's Hospital at Westmead weekly for dietary review with the experienced study dietitian (Megan Gow) (i.e. 8 x 1 hour visits in 8 weeks). After the 8 week very low energy diet participants will be transitioned to a standard hypocaloric diet over a 2-4 week period depending on the individual participant's preference. During this transition period, participants will continue weekly dietary review with the study dietitian at The Children's Hospital at Westmead (i.e. 2-4 x 1 hour visits over 2-4 weeks). Once transition is complete participants will follow their individualised hypocaloric diet for 34 weeks. During the follow-up period participants will attend The Children's Hospital at Westmead fortnightly to monthly for dietary review depending on participant preference (i.e. 5-10 x 1 hour visits during the follow-up period). In addition to the face-to-face contact, participants will receive additional support throughout the trial in the form of email/SMS/phone calls from the study dietitian. Detailed meal plans will be designed with patient preference in mind at every phase of the study. These meal plans will be adjusted as required throughout the trial. Nutrition coaching from the experienced dietitian will also be incorporated into dietary reviews. Examples of nutrition coaching techniques used in the trial include goal setting at each review and creating task lists to achieve goals. Adherence to the dietary intervention will be assessed throughout the trial using 24 hour dietary recalls. However, ultimately, adherence to the 8 week very low energy diet phase will be assessed by weight loss, i.e. at least 5% weight loss is expected in 8 weeks if the very low energy diet is adhered to (if a participant does not achieve 5% weight loss they will be considered to have not adhered to the diet).
Intervention code [1] 294246 0
Treatment: Other
Intervention code [2] 294258 0
Lifestyle
Intervention code [3] 294259 0
Behaviour
Comparator / control treatment
No control group - pilot study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297726 0
Presence/absence of type 2 diabetes
Assessed according to the American Diabetes Association criteria (i.e. an HbA1c >/= 6.5%, fasting plasma glucose >/= 7.0 mmol/L or a 2 hour post glucose load plasma glucose >/= 11.1 mmol/L) from fasting blood test and an oral glucose tolerance test.
Timepoint [1] 297726 0
Baseline
8 weeks
34 weeks
Primary outcome [2] 297727 0
Change in body mass (continuous outcome) as assessed using calibrated digital scales to the nearest 0.1 kg.
Timepoint [2] 297727 0
Baseline
8 weeks
34 weeks
Secondary outcome [1] 322017 0
Change in intrahepatic triacylglycerol content (continuous outcome) assessed by hydrogen proton magnetic resonance spectroscopy (1H-MRS).
Timepoint [1] 322017 0
Baseline
8 weeks
34 weeks
Secondary outcome [2] 322018 0
Change in body composition (i.e. body fat percentage, continuous outcome) assessed by bioelectrical impedance analysis (BIA).
Timepoint [2] 322018 0
Baseline
8 weeks
34 weeks
Secondary outcome [3] 322019 0
Acceptability of the diet by qualitative interview conducted by the dietitian.
Timepoint [3] 322019 0
8 weeks
Secondary outcome [4] 322020 0
Change in psychological dimensions of eating behaviours (continuous outcome) assessed by the Dutch Eating Behaviour Questionnaire (Child version).
Timepoint [4] 322020 0
Baseline
8 weeks
34 weeks
Secondary outcome [5] 322021 0
Change in health related quality of life (continuous outcome) assessed by the Peds-QL questionnaire.
Timepoint [5] 322021 0
Baseline
8 weeks
34 weeks
Secondary outcome [6] 322022 0
Changes in cardio-metabolic profile (dichotomous outcome) assessed by blood serum blood assay for presence of dyslipidaemia and elevated liver enzymes, automatic sphygmomanometry for the presence of hypertension and BMI according to the International Obesity Task Force criteria for the presence of obesity.
Timepoint [6] 322022 0
Baseline
8 weeks
34 weeks
Secondary outcome [7] 322060 0
Change in intrapancreatic triacylglycerol content (continuous outcome) assessed by hydrogen proton magnetic resonance spectroscopy (1H-MRS).
Timepoint [7] 322060 0
Baseline
8 weeks
34 weeks

Eligibility
Key inclusion criteria
Children and adolescents aged 7-18 years with a diagnosis of type 2 diabetes (fasting glucose >/=7.0 mmol/L and/or 2 hour glucose tolerance >/=11.1 mmol/L and/or HbA1c >/=6.5%) as defined by the American Diabetes Association.
Minimum age
7 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Type 1 diabetes
2. Secondary causes of obesity
3. Psychiatric disturbance
4. On weight loss medications or medications known to cause weight gain (other than insulin)
5. Neither parent/ carer speaks English.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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)
NSW
Recruitment hospital [1] 5469 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 12951 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 293154 0
Charities/Societies/Foundations
Name [1] 293154 0
Diabetes Australia Research Trust (2014)
Address [1] 293154 0
Postal Address:
PO Box 3156
Canberra ACT 2601

Office Location:
Level 1, 101 Northbourne Ave
TURNER ACT 2612
Country [1] 293154 0
Australia
Primary sponsor type
Individual
Name
Professor Chris T Cowell
Address
Endocrinology, The Children's Hospital at Westmead, Locked Bag 4001, Westmead, NSW, 2145
Country
Australia
Secondary sponsor category [1] 291955 0
None
Name [1] 291955 0
Address [1] 291955 0
Country [1] 291955 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294653 0
The Sydney Children's Hospital Network Human Research Ethics Committee
Ethics committee address [1] 294653 0
Locked Bag 4001, Westmead, NSW, 2145
Ethics committee country [1] 294653 0
Australia
Date submitted for ethics approval [1] 294653 0
15/08/2012
Approval date [1] 294653 0
06/02/2013
Ethics approval number [1] 294653 0
12/SCHN/297

Summary
Brief summary
The aim of this pilot study is to investigate the effectiveness of a very low energy diet (VLED), consisting primarily of meal replacements, to resolve the metabolic abnormalities underlying type 2 diabetes in children and adolescents. We hypothesise that children and adolescents who achieve rapid weight loss through short-term use of a VLED will reverse the metabolic abnormalities underlying their type 2 diabetes. Our approach to cure type 2 diabetes is innovative and is in contrast to current practice which is aimed at managing type 2 diabetes. To our knowledge this study will be a world's first with the aim of curing diabetes in youth.
Trial website
Trial related presentations / publications
ML Gow, LA Baur, CT Cowell and SP Garnett. Youth with type 2 diabetes who adhere to a very low energy diet achieve rapid weight loss and remission of type 2 diabetes; the SHAKE IT pilot study. Australia and New Zealand Obesity Society Annual Scientific Meeting, Melbourne, 15-17 October 2015 (poster presentation).
Public notes

Contacts
Principal investigator
Name 64502 0
Prof Chris T Cowell
Address 64502 0
Endocrinology, The Children's Hospital at Westmead, Locked Bag 4001, Westmead, NSW, 2145
Country 64502 0
Australia
Phone 64502 0
+61298453050
Fax 64502 0
Email 64502 0
chris.cowell@health.nsw.gov.au
Contact person for public queries
Name 64503 0
Mrs Megan Gow
Address 64503 0
Endocrinology, The Children's Hospital at Westmead, Locked Bag 4001, Westmead, NSW, 2145
Country 64503 0
Australia
Phone 64503 0
+61298453119
Fax 64503 0
Email 64503 0
megan.gow@health.nsw.gov.au
Contact person for scientific queries
Name 64504 0
Mrs Megan Gow
Address 64504 0
Endocrinology, The Children's Hospital at Westmead, Locked Bag 4001, Westmead, NSW, 2145
Country 64504 0
Australia
Phone 64504 0
+61298453119
Fax 64504 0
Email 64504 0
megan.gow@health.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary