The Effect of a Structured Weight-loss Programme on the Metabolic Profiles of Obese and Overweight Children

STUDY DESIGN

Aims:

1. To identify the effects of a weight-loss programme on the metabolic profiles of obese and overweight children through global profiling of urine, before during and after the intervention.
2. To assess how chemicals (metabolites) in the food eaten by participants compared with those found in their urine through the metabolomic analysis of duplicate meals during the study.

Methodology:

• This will be an observational cohort study type of methodology. A cohort of overweight or obese children who have signed up to a well-known commercial summer weight loss camp (MORElife) will be recruited with parental consent.
• Each child will be attending the MORELife weight loss camp for a minimum of 2 weeks and a maximum of 5 weeks during which time again they are either residential or returning home after 5 pm.
• The programme consists of healthy but hypocaloric balanced meals as well as an exercise programme including a wide range of sports, team games and day trips. Throughout this the children are educated about healthy eating behaviour and choices and given support to achieve a sustained change in lifestyle. At the end of the camp they are followed up for three months by camp support staff via a weekly telephone call to check progress and offer encouragement. During this time and thereafter they can also interact with the support team via social media, email and an interactive web portal.
• Sample collection for metabolic profiling will be in the form of spot urine samples and stool samples from those who wish to and are happy to consent to proved either/both. These will be taken on arrival (Day Zero) prior to commencement of the weight loss programme to give the Control (baseline) sample. Thereafter a 'mid-point' sample will be taken around half way through the camp and a final sample on the day that they leave.
• Associated information for each child such as height, baseline weight on arrival and estimate basal metabolic rate (BMR), and body mass index (BMI) and changes in these parameters through the duration of the camp will be provided to the study by the camp coordinators with parental permission and consent.
• From the samples taken, metabolic profiling of individuals pre- during and post- intervention will be completed using a combination of untargeted and targeted spectroscopic assays including: Nuclear Magnetic Resonance spectroscopy and Mass Spectroscopy profiling of chemicals such as lipids, bile acids, amino acids, bacteria and others found in stool and urine.
• 1-2 meals eaten by the children during the camp will be analysed also by taking a duplicate meal and pureeing it then putting it through similar techniques to the urine and stool samples to compare the chemicals in the food with those excreted from the body.

Participants:

At least 30 male and female children/adolescents aged between 8 and 17 years who are overweight or obese according to classifications for their age. All children in the study will have signed up for the MORElife summer camp 2015 in Leeds, U.K and provided parental consent to take part.

Power calculations:

At the present time there is no data present on the impact of such an intervention in children on the metabolic profile and so such a calculation is not possible, however the numbers that the investigators have chosen reflect other similar studies allowing for a 33.3% drop out rate and the investigators feel confident that they should show representative results.

Health Screening:

Participants will be assessed for suitability to take part in the camp by the organisers of the weight loss camp (MORElife) and so all children who are accepted for entry into the camp will be taken as eligible for this study. The investigators will not be carrying out any separate intervention and are simply collecting samples from them during their time at the camp.

Consent and Participant Information:

Consent forms will be given to the parents of the children prior to beginning the camp as well as information for both parents and children to read before deciding whether they wish to take part. They can contact a member of the research team at any time prior to the study for more information and of course are free to withdraw at any time after agreeing.

Sample collection:

• Each child will be asked to submit a urine sample on day 0 (first day of camp before beginning weight loss programme). Then regular samples will be collected for the duration of their time at the camp with a final one at the reunion around one year later.
• The camp will be asked to provide the investigators with a duplicate lunch and dinner meal to that given to the children so that it can be pureed and prepared for analysis and comparison with the children's metabolic profiles.

Withdrawal Criteria: Children are under no pressure to join the study and can withdraw at any time with no explanation and without their time at Summer camp being affected.