Ignite Creation Date:
2024-05-06 @ 7:48 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02608398
Status:
COMPLETED
Last Update Posted:
2016-09-29
First Post:
2015-08-13
Brief Title:
The Effect of a Structured Weight-loss Programme on the Metabolic Profiles of Obese and Overweight Children
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
The Effect of a Structured Weight-loss Programme on the Metabolic Profiles of Obese and Overweight Children
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 eitherboth 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 childrenadolescents 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 UK 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 333 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 childrens 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
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 eitherboth 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 childrenadolescents 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 UK 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 333 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 childrens 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None