Applicability and Efficiency of Different Approaches in Lifestyle Interventions - Lifestyle Management and Changes in Everyday Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 339
- 试验地点
- 3
- 主要终点
- Psychological Flexibility (AAQ-2)
研究概览
简要总结
The purpose of this study is to examine the effectiveness and applicability of different interventions designed for enhancing overall wellbeing. Lifestyle changes, as well as psychological and physiological health variables are assessed. The interventions are based on the principles of cognitive behavioural therapy, and delivered either face-to-face, via mobile phone application, or Internet.
详细描述
The study focuses on targeting overweight, stress, and impaired overall wellbeing with new cost-effective intervention methods. The intervention methods are based on the principles of cognitive behavioural therapy (CBT) and further acceptance-commitment therapy (ACT). The interventions are delivered either face-to-face, via mobile application, or via Internet. The purpose of each intervention is to improve the subjects lifestyles and activate them towards beneficial changes in their everyday life. The psychological and physiological effects of interventions are measured with various invasive and non-invasive methods. The study gives new insight into effectiveness and acceptability of up-to-date psychological intervention methods, and new knowledge of different ways to deliver interventions for improving wellbeing of an individual.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index (BMI) 27-34.9
- •Psychological Stress (3/4 or 4/4 points in General Health Questionnaire)
- •Possibility to use computer and internet connection
排除标准
- •Diagnosed severe chronic illness
- •Symptomatic cardiovascular disease
- •Type 1 or 2 diabetes
- •Severe psychiatric conditions
- •Remarkable clinical operation within past 6 months
- •Heart attack or stroke within past 6 months
- •Kidney disease requiring Dialysis
- •Regular use of cortisone pills
- •Eating disorder: bulimia
- •Disability pension for psychological reasons
- •Pregnancy or breastfeeding within the pas 6 months
- •Shift work (in three shifts) or night work
- •Participation in other intervention studies during the present study
研究组 & 干预措施
Face-to-Face
Group meetings face-to-face using intervention for wellbeing with ACT principles.
干预措施: Wellbeing intervention (ACT) (Behavioral)
Mobile
Intervention for wellbeing via mobile phone application with ACT principles.
干预措施: Wellbeing intervention (ACT) (Behavioral)
Internet
Intervention for wellbeing via Internet (Virtual Health Check and Coaching).
干预措施: Wellbeing intervention (Internet) (Behavioral)
Control
Control group, no intervention.
干预措施: No intervention (Behavioral)
结局指标
主要结局
Psychological Flexibility (AAQ-2)
时间窗: Change from Baseline in Psychological Flexibility at 8.5 months
次要结局
- Blood lipids(pre, post, follow-up (0, 10, 36))
- Diet (interview, questionnaire)(pre, post, follow-up (0, 10, 36 weeks))
- Depression(Pre, post, follow-up (0, 10, 36 weeks))
- Perceived and physiological stress (questionnaire, heart rate variability measurement)(pre, post, follow-up (0, 10, 36 weeks))
- Sleep (ESS, Basic Nordic Sleep Questionnaire, actigraphy, sleep diary)(pre, post, follow-up (0, 10, 36 weeks))
- Physical Activity (questionnaire)(pre, post, follow-up (0, 10, 36 weeks))
- User experiences concerning technology (interview, questionnaire)(during, post, follow-up (2, 10, 36 weeks))