Gender-sensitive Enhancement of Common Weight Loss Strategies for Overweight and Obesity: a Personalized Smartphone App
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 213
- 试验地点
- 2
- 主要终点
- Changes in Subjective Illness Representations
研究概览
简要总结
The major aim of the proposed study is to develop a gender-sensitive individually tailored add-on intervention that focusses on improving individual gender-specific SIRs (subjective illness representations) in obese or overweight individuals. We will investigate whether this will improve compliance with and long-term success of common weight loss interventions. The effectiveness of this intervention in every-day-life with regard to weight-related behavioral changes and weight loss will be evaluated within a randomized controlled setting.To enhance the applicability of the intervention in every-day-life and its dissemination we plan to develop a smart-phone-based intervention.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obesity class I or II with subjectively experienced weight-related impairment and a current will to lose weight.
- •Overweight (i.e. BMI between 25 and 29.9 kg/m²) with weight-related health problems and/or visceral adipose tissue and/or high psychosocial weight-related distress with a current will to lose weight.
排除标准
- •Obesity Class III (i.e. BMI >39.9 kg/m²).
- •Current (or within the last 12 months) involvement in a structured weight loss intervention.
- •Insulin-dependent type 1 diabetes.
- •Previous or intended bariatric surgery.
- •Current psychotherapeutic treatment of weight-related health problems.
- •Weight-enhancing drugs.
- •Drugs which promote weight-loss (e.g. anti-obesity drugs).
- •Weight-enhancing health problems which are not yet treated.
- •Cancerous disease within the last five years.
- •Current substance-use disorders, depression, psychosis, suicidal tendency or pregnancy.
- •Severe cognitive impairments.
- •Insufficient knowledge of the german language.
- •Binge-Eating Disorder or Bulimia nervosa.
结局指标
主要结局
Changes in Subjective Illness Representations
时间窗: The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later.
The effectiveness of the intervention with regard to subjective illness representations (IPQ-R) will be investigated respecting gender-related differences.
Changes in Physical Activity
时间窗: The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later.
The effectiveness of the intervention with regard to physical activity (motion sensors) will be investigated respecting gender-related differences.
Changes in Eating Behavior
时间窗: The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later.
The effectiveness of the intervention with regard to eating behavior (DEBQ) will be investigated respecting gender-related differences.
次要结局
- Weight Change(The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later.)
- Changes in Emotional Competence(The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later.)
- Changes in Weight-Related Life Quality: ORWELL-97(The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later.)
- Changes in Impulsivity(The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later.)
- Changes in Self-Efficacy: General-Self-Efficacy-Scale(The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later.)
- Changes in Coping Strategies(The outcome will be measured at four assessments. At the beginning of the study (day 0), after finishing the app intervention (12 weeks later) and at to follow-up assessments 6 and 12 months later.)