The SHAKE IT pilot study: Shakes and meal replacements to Help children and Adolescents Kick-start healthy Eating In Type 2 diabetes

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).