Using functional Magnetic Resonance Imaging to assess the impact of Mandolean training on the neural control of obesity in young people: a feasibility study for the Bristol Nutrition BRU

INTERVENTION: Participants will be randomly allocated to one of 2 groups: (1) Standard care or (2) Standard care plus Mandolean training. Standard care intervention: Participants initially allocated to the standard care arm will receive a package of care specifically tailored for the treatment of obesity as per routine care at the Care of Childhood Obesity (COCO) clinic in the Children?s Hospital. This will be referred to as 'standard care', although this is likely to reflect an enhanced level of care to that usually received in primary care settings. In standard care, emphasis will be placed on implementing changes to increase levels of enjoyable physical activity to national recommended levels (60 minutes exercise a day for children) alongside a balanced diet, based on the 'Eatwell Plate' (Food Standards Agency). Families will be encouraged to set their own dietary goals and targets, with practical advice and guidance from the dietician. In encouraging activity, the approach is one of facilitation rather than prescription. Motivational interviewing techniques are used to engage patients and families in the decision‐making process for lifestyle changes. This is consistent with self‐determination principles and is more likely to lead to responsibility for long term change (Deci et al., 1990). Standard care appointments will be delivered at 6 weekly intervals over a 6‐month period, resulting in 6 contacts in total for this arm of the study. Experimental intervention: During the Mandolean intervention, participants will receive the same standard care package as the control group with the addition of Mandolean therapy. The Mandolean is a portable weighing scale connected to a small computer which can generate a graphical representation of food removal from the plate with weight of food (grams) on the y axis and time (minutes) on the x axis. The patient puts a measured portion of food determined by a therapist on the scale and the computer records and displays, in real‐time CONDITION: Childhood obesity and neuroimaging ; Nutritional, Metabolic, Endocrine ; Obesity PRIMARY OUTCOME: Patient BMI SDS (standard deviation score) at the end of the intervention period, converted from measures of height and weight using a standard algorithm. Height (using a stadiometer) and weight (using calibrated weighing scales) will be measured at baseline and at 6 months INCLUSION CRITERIA: 1. The target population for the obese group will be obese adolescents and young adults aged 11 years or above with a BMI >/= 95th percentile (definition of obesity in National Child Measurement Programme) 2. The target population for the MC4­R group will be adolescents and adults with obesity confirmed to be due to MC4­R mutation (Cambridge Genetics of Simple Obesity Study) 3. The target population for the control group will be normal­‐weight adolescents and young adults aged 11 years or above SECONDARY OUTCOME: 1. Maintained BMI or BMI SDS improvement at 6 months post therapy (12 months after study entry). Height (using a stadiometer) and weight (using calibrated weighing scales) will be measured at part of routine clinic appointments following participation in the study. Height and weight measurements will be recorded from medical notes from the closest clinic appointment to 12 months after study entry.; 2. Eating speed and self‐determined portion size measured using the Mandolean (weighing scale that records the rate at which food is removed from the plate) in test meals at time 0 (baseline) and 6 months (end of intervention); 3. Blood plasma levels of ghrelin and PYY, pre‐ and post‐intervention. Blood samples will be taken during each of the two OGTT fMRI sessions at baseline and end of intervention. According to the OGTT, samples will be taken prior to glucose ingestion then 30, 60 and 90 minutes post‐glucose ingestion. Blood samples will be processed and analysed using established protocols; 4. Brain activity in response to (a) glucose ingestion, and (b) pictures of food, pre‐ and post‐intervention. Brain activity will be measured during each of the two OGTT fMRI sessions at baseline and end of intervention. The Blood Oxygen Level Dependent (BOLD) response will be measured in response to pictures of food