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临床试验/NL-OMON22186
NL-OMON22186招募中不适用

The effect of extended personalisation components to a combined lifestyle intervention program.

TNO in collaboration with GGD-NOG (owner of SLIMMER)0 个研究点目标入组 120 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • In order to be eligible to participate in this study, a subject must meet all of the following criteria in addition to the above:
  • Physically able to participate in a lifestyle intervention program;
  • Motivated to join lifestyle program.
  • Able to use online technology on a tablet or a PC/laptop which has good access to the internet;
  • In possession of a Smartphone running on a recent version of iOS or Android;
  • Willing to comply with all study procedures;
  • Proficient in the Dutch language (speaking and reading).

排除标准

  • Exclusion criteria from the SLIMMER programme:
  • 1)Behavioural problems that obstruct group sessions
  • 2)Cognitive impairment (IQ < 80);
  • 3)Psychopathology, that requires a different treatment
  • 4)Having an underlying cause of obesity that can be treated;
  • 5)incompetent to act for oneself, without consent of the legal representative.
  • Participation in another regular vigorous exercise program (sporting at least 3 times a week) and/or diet program
  • Participation in any clinical trial including administration of substances up to 90 days before Day 01 of this study
  • Severe cardiovascular disease (this also includes history of cardiac dysrhythmia), unless GP gives agreement
  • Not being able to attend 80% of the planned group- and individual sessions;
  • Planned surgery during the entire study period
  • Pregnant or lactating women
  • Using on a regular base: anti-inflammatory drugs (NSAID’s), corticosteroids (including topical and inhalation corticosteroids), TNF-alpha blockers, and salicylates (e.g. ascal)
  • Having a chronic inflammatory disease, including asthma, rheumatic fever, IBD, COPD
  • Other bowel diseases, including Chron’s disease and Colitis Ulcerosa.
  • Alcohol consumption > 21 units/week
  • Recent blood donation (<1 month prior to the start of the study)
  • Not willing to give up blood donation during the study
  • Personnel of TNO Healthy Living, their partner and their first and second degree relatives

研究者

发起方
TNO in collaboration with GGD-NOG (owner of SLIMMER)

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