The Effect of a Structured Weight-loss Programme on the Metabolic Profiles of Obese and Overweight Children
Condition: Obesity
MeSH terms: Overweight; Weight Loss
Study type: Observational

Summary: 
      Aim:

        -  The overall aims of this study to look at what changes are seen overweight and obese
           (very overweight) children, as they get thinner.

        -  Specifically the investigators are interested in the chemicals and bacteria that
           children pass in their urine and stool because looking at how these change as it tells
           us about how their gut and other bodily systems are adapting.

      Hypothesis: Metabolic profiling is a useful and accurate tool for observing and monitoring
      weight loss in children

      Study plan:

        -  To observe this weight loss process in children, the investigators will be attending a
           commercial weight loss camp called 'MORElife' which takes place every year in Leeds.
           This camp is attended by children age 8-17years who are overweight or obese, for between
           two and five weeks. It aims to help them lose weight through a structured diet,
           exercise, education and support program.

        -  The investigators plan to, with the consent of the parent and agreement the child ask if
           they would kindly give us a urine sample at the beginning and end of their time on the
           camp. For those staying longer than 2 weeks the investigators will also ask for a sample
           in the middle if possible.

        -  In addition for those children who consent, the investigators will also ask for a small
           stool (poo) sample at these same time points although there is no obligation to
           participate at all in the study and it will not affect their time on the camp whatever
           they decide.

        -  Any children who will be attending the MORElife reunion (arranged by the camp at around
           10-12 months after) who agree will be asked for a final urine and stool sample to look
           at the long-term effects.

        -  Each sample is given a code so as to remain anonymous, frozen and transported to the
           university laboratory to be analyzed.

        -  With permission and consent the investigators will also collect some information about
           the children such as, weight and height from the camp coordinators as well as samples of
           the diet that they will be fed and example of exercise activities to give a full picture
           so that results can be as accurate as possible.
    

Detailed description: 
      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.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): NO intervention by the research group - this is an observational study. urine samples simply collected as children lose weight on their diet and exercise camp
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Overweight or obese children aged between 8-17 years attending the MORElife weight loss
        Summer Camp
      
Biospecimen description: 
      urine and stool samples will be collected from those who consent
    
Keywords: obesity; weight-loss; metabonomics; gut microbiome