sing 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 BR

Completed

• Conditions: Childhood obesity and neuroimaging; Nutritional, Metabolic, Endocrine; Obesity

• Registration Number: ISRCTN84202126
• Lead Sponsor: niversity of Bristol

Brief Summary

1. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30466438

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-03-30
• Study Start: 2018-02-22
• Last Update Posted: 14 January 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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