Motivational Interviewing for Weight Loss in the Management of Non Alcoholic Fatty Liver Disease - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 231
- 试验地点
- 2
- 主要终点
- Change in weight after 1 year compared to baseline
研究概览
简要总结
The goal of this study is to assess if motivational counselling works to reduce the weight in participants with Non Alcoholic Fatty Liver Disease (NAFLD).
详细描述
Participants with NAFLD who meet inclusion and exclusion criteria and who give informed written consent, will be randomly assigned to the intervention and control group. Randomization will be done by using a random sequence generator with concealed allocation.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years to 60 years
- •Body Mass Index (BMI) is 25 kg/m^2 or more
- •Newly diagnosed with NAFLD based on clinical history, ultrasound scan and laboratory values
排除标准
- •Any medical condition that will significantly alter the weight eg: hypothyroidism, hyperthyroidism, Cushing disease
- •Having moderate/severe depressive disorders or psychotic symptoms and or substance use disorders that would reduce their capacity to give consent and engage in Motivational interview
- •Who are on drugs which will affect weight or mood/affect (eg: corticosteroids)
- •Pregnancy or expecting to be conceive within the study period
- •Having any health conditions that would impede engagement in physical activities
- •Having any health conditions that would compromise the ability to follow the recommended dietary behaviors
- •Concurrent involvement in another weight loss programme
结局指标
主要结局
Change in weight after 1 year compared to baseline
时间窗: Baseline, 3 months, 6 months, 12 months
Weight is measured using a digital scale
Change in platelet count after 1 year compared to baseline
时间窗: Baseline and 12 months
Lower platelet count has a poor outcome
Change in Aspartate aminotransferase (AST) level and Alanine aminotransferase (ALT) level after 1 year compared to baseline
时间窗: Baseline and 12 months
Lower AST and ALT levels have a better outcome
Change in total fat percentage and visceral fat percentage after 1 year compared to baseline
时间窗: Baseline and 12 months
Both are measured by impedance method.
Change in waist circumference and hip circumference after 1 year compared to baseline
时间窗: Baseline and 12 months
The waist circumference is measured at the narrowest part of the waist. The hip circumference is measured at the widest part of the hips. Both are measured by using a measuring tape.
次要结局
- Change in motivation for weight loss after 1 year compared to baseline(Baseline, 12 months)
- Change in depression, anxiety and stress after 1 year compared to baseline(Baseline, 12 months)
- Change in quality of life after 1 year compared to baseline(Baseline, 12 months)
研究者
Madunil Anuk Niriella
Professor in Gastroenterology
University of Kelaniya