NCT02608398已完成不适用
The Effect of a Structured Weight-loss Programme on the Metabolic Profiles of Obese and Overweight Children
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The effect of a weight-loss programme on the metabolic profile of obese/overweight children (metabolites measured in urine/stool/food using Nuclear Magnetic Resonance Spectrometry and Mass Spectroscopy)
研究概览
简要总结
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.
详细描述
STUDY DESIGN
Aims:
- 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.
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children attending the MORElife Summer Camp with consent
排除标准
- 未提供
结局指标
主要结局
The effect of a weight-loss programme on the metabolic profile of obese/overweight children (metabolites measured in urine/stool/food using Nuclear Magnetic Resonance Spectrometry and Mass Spectroscopy)
时间窗: 12 months
Metabolites detected and compared using Nuclear Magnetic Resonance Spectrometry and Mass Spectroscopy. Using computer software, analysis of these spectra and metabolite identification is carried out and Principal Component Analysis (PCA) completed
次要结局
未报告次要终点
研究者
研究点 (1)
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