NL-OMON51873已完成不适用
The effect of extended personalisation components to a combined lifestyle intervention program. - Personalised combined lifestyle intervention (Slimmer-Personalised)
TNO0 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
- 已完成
- 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
- 年龄范围
- 18 至 64（—）
入选标准
- •Men and women aged 18-70 years
- •BMI > 30 kg/m2, or
- •BMI > 25 kg/m2 with an increased risk of cardiovascular diseases and/or type
- •2 diabetes, based on the Dutch primary care guidelines cardiovascular risk
- •management (CVRM), obesity and diabetes.
- •Increased waist circumference (women > 80 cm and men > 92 cm);
- •Little physical activity and suboptimal diet (room for improvement);
- •Physically able to participate in a lifestyle intervention program;
- •Motivated to join lifestyle program.
- •Able to use online technology on a tablet and 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
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •Exclusion criteria from the SLIMMER program:
- •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 the 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
- •Preferably not use anti-inflammatory drugs (NSAID*s), corticosteroids
- •(including topical and inhalation corticosteroids), TNF-alpha blockers on a
- •regular base
- •Other bowel diseases, including Chron*s disease and Colitis Ulcerosa.
- •Alcohol consumption > 21 units/week
- •Recent blood donation (<1 month before 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
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