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

NCT02608398 | Completed DMC

• 1 other identifier: 15IC2685
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

obesity; weight-loss; metabonomics; gut microbiome

Outcome Measures

Primary Outcomes (1)

• 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)

  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

  12 months

Study Arms (1)

overweight children at weight-loss camp

This is an observational study there is no intervention. The investigators will carry out metabolic profiling on a cohort of overweight or obese children who are attending a commercial weight loss camp for 2-5 weeks.

Other: no intervention

Interventions

no intervention OTHER

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

overweight children at weight-loss camp

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Overweight or obese children aged between 8-17 years attending the MORElife weight loss Summer Camp

You may qualify if:

• All children attending the MORElife Summer Camp with consent

You may not qualify if:

• nil

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College London

London, London, SW7 2AZ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

urine and stool samples will be collected from those who consent

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Elaine - Holmes, PhD

  Imperial College London

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: November 18, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 29, 2016

Record last verified: 2016-09

Locations

GB (1)