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临床试验/NCT00407420
NCT00407420已完成不适用

Can a Novel Treatment Using "Mandometer®" Technology Improve Weight Loss in a Childhood Obesity Clinic?

University of Bristol2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2004年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
106
试验地点
2
主要终点
BMI SDS or Z-score

研究概览

简要总结

We run a successful clinic in Bristol for children with severe obesity who already demonstrate many features to suggest they are at increased risk of early diabetes and heart disease. However, we have found that young children respond better to simple interventions than do adolescents. We have used a new treatment regimen "Mandometer®" to help our most difficult adolescent cases lose weight. We would like to do a study to see if all adolescents might improve weight loss using this technology compared to what we routinely offer

详细描述

Childhood obesity is rapidly reaching epidemic proportions in the United Kingdom. Recent studies have indicated a prevalence level for obesity of 15% at 15 years of age. The implications for metabolic, cardiovascular and cancer risk in later life are enormous. The International Obesity Task Force (IOTF) and the European Association for the Study of Obesity (EASO) have identified childhood obesity as a matter for urgent attention. However, there are very few obesity clinics for children in the UK and effective treatment regimens are simply not available. We have developed an obesity clinic at the Royal Hospital for Children in Bristol and observed effective weight reduction in pre-pubertal children. Our simple treatment framework has proved far less effective in adolescence. We have therefore collaborated with an eating disorder clinic from the Karolinska Institute in Sweden to develop a novel therapy to treat obesity using modified equipment originally designed to treat adolescents with DSM-IV eating disorders. Pilot data indicate that adolescents are better able to address the issue of weight reduction within this treatment modality. Having established the software and treatment process we now wish to perform a randomised, control trial to test the efficacy of this new treatment against that currently provided.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Obese children and adolescents aged 10-18

排除标准

  • Having associated learning difficulties
  • Who have received medication for associated insulin resistance
  • Refusal of parent/legal guardian to give informed consent.

研究组 & 干预措施

Mandometer

Experimental

Active intervention - one meal eaten per day off Mandometer

干预措施: Mandometer (Device)

Mandometer

Experimental

Active intervention - one meal eaten per day off Mandometer

干预措施: Lifestyle (Behavioral)

Control

Active Comparator

Nutritional and activity advice alone

干预措施: Mandometer (Device)

结局指标

主要结局

BMI SDS or Z-score

时间窗: 12 months primary/ 18 months secondary outcome

Body Mass Index standard deviation (s.d.) scores also called Z-scores, are measures of relative weight adjusted for a child's age and sex. In terms of this score for weight management, a lower score would be viewed a beneficial outcome at the end of the intervention. The change in BMI SDS was calculated as the value at 12 months minus value at baseline ( a negative score being beneficial).

次要结局

  • Insulin Sensitivity(12 months)
  • Speed Food Consumed(12 months)
  • Percentage Body Fat (Measured Using a Tanita Bio-impedance Monitor Model BC-418MA)(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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