ISRCTN99840111已完成不适用
HELP trial: randomised controlled trial of the Healthy Eating Lifestyle Programme for adolescents
Institute of Child Health (ICH) (UK)0 个研究点目标入组 174 人开始时间: 2011年1月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 174
研究概览
简要总结
2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22088133 2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28687677 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29449292
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 13/07/2012:
- •1. Young people aged 12 - 19 years, either sex
- •2. Obese (body mass index [BMI] greater than 95th centile for age and sex)
- •Previous inclusion criteria until 13/07/2012:
- •1. Young people aged 13 - 17 years, either sex
- •2. Obese (body mass index [BMI] greater than International Obesity Task Force [IOTF] thresholds for age and sex)
排除标准
- •Current exclusion criteria:
- •1. Participants with significant mental health problems or undergoing mental health treatment
- •2. Other chronic illness, known secondary obesity, monogenic obesity syndrome or use of medications known to promote obesity. Added 06/10/2015: Young people with asthma will be included in the study so long as they have not had more than one course of oral steroids in the preceding 3 months (where course is less than or equal to 5 days), or are on more than the first starting dose of inhaled steroids as per British Thoracic Society Guidelines.
- •3. Participants with significant learning disability
- •4. Participants with lack of command of English sufficient to render them unable to participate effectively in the planned intervention. The great majority of eligible young people from black or minority ethnic groups in this population have good command of English. Given the importance of standardising the intervention, it will not be possible to use interpreters to enable parents with poor English to participate. To allow as many young people as possible to participate while maintaining the external validity of the study, we will allowing another relative with good English to participate alongside the young person (if they wish it).
- •5. Participation in behavioural weight management programmes in the past 12 months. This does not include participation in commercial programmes such as Weight Watchers.
- •6. Young people with BMI greater than or equal to 45 kg/m2. We exclude this group as the evidence suggests they are unlikely to benefit from a community based intervention such as HELP.
- •Previous exclusion criteria until 13/07/2012:
- •6. Young people with BMI greater than or equal to 40 kg/m2. We exclude this group as the evidence suggests they are unlikely to benefit from a community based intervention such as HELP.
研究者
相似试验
已完成
不适用
Multicentre randomised controlled trial of HELP (heat loss prevention) in the delivery roomHypothermia in premature infantsNeonatal DiseasesHypothermiaISRCTN85045728niversity of Alberta and Sunnybrook and Women's College Health Sciences Centre (Canada) and The Vermont Oxford Network (USA)1,685
已完成
不适用
A randomised controlled trial to investigate the effectiveness of two commonly-used lifestyle-based weight-loss programmes across three countriesOverweight and obesityNutritional, Metabolic, EndocrineObesityISRCTN85485463Medical Research Council Human Nutrition Research (UK)804
已完成
不适用
Evaluation of a new Healthcare Social Media platform (ZWIP) for frail elderly: improving care coordination and self-managementISRCTN11165483ZonMw (Netherlands)1,044
已完成
不适用
Efficacy of an educational school-based intervention to reduce prevalence of obesity in childhood in CataloniaObesityISRCTN29247645niversity of Rovira i Virgili (Universitat Rovira i Virgili) (Spain)1,400
已完成
不适用
Gaseous oxygen enrichment before implantation as a means of improving organ function in liver transplantatioLiver diseaseISRCTN00167887niversity Hospital Duisburg-Essen (Germany)116