Childhood obesity and neuroimaging Nutritional, Metabolic, Endocrine Obesity
Conditions
Interventions
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 allocate
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Children and adults with learning difficulties, visual or hearing difficulties, dysmorphic features suggesting other syndromes such as Prader?Willi 2. Children and adults with endocrine disorders such as hypothyroidism 3. Children and adults with iatrogenic causes of obesity ? cranial surgery, anticonvulsant therapy 4. Children and adults whose first language is not English 5. Patients for whom it would not be safe to enter the MR environment. Contraindications for participation are: 5.1. Metal implants (internal defibrillator, cochlear implant, artificial heart valves, implanted drug infusion ports, metal dental work if not removable, cardiac pacemaker, artificial limbs or metallic joint prostheses, metal pins, screws plates or surgical staples, intrauterine device) 5.2. Tattoos with metallic ink or unremovable body piercing which might be attracted to the magnet used during fMRI scanning and to avoid image distortion 5.3. Pregnancy, to avoid harm to the foetus 5.4. History of neurological disease, traumatic brain injury, mental illness 5.5. Claustrophobia, to avoid including participants with brain abnormalities or at risk of anxiety, in particular, anxiety related to being in enclosed places 5.6. Medical health problems requiring medication, to avoid disruption to brain function and responsiveness to glucose or test meals 5.7. Weight above 152kg due to the limits of the scanner bed, and girth of less than 210cm in order to fit inside the 70cm diameter bore of the scanner 5.8. Vegetarian or vegan, so that the images of food shown in the cue-reactivity task are not aversive to participants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed