NCT05736536已完成不适用
Health Intervention on Behaviour Change to Act for Adults With Type 2 Diabetes Mellitus and Body Mass Index of ≥ 23kg/m2: a Quasi-Experimental Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 4
- 主要终点
- Changes of readiness to change for weight loss (behaviour)
研究概览
简要总结
This quasi-experimental study aims to determine the effectiveness of a health intervention (Chance2Act) on behaviour change to act for weight loss among overweight/obese type 2 diabetes adults.
The main question it aims to answer is:
- Is the new health intervention (Chance2Act) effective in changing overweight/obese type 2 diabetes adults from not being ready to act, to take action to lose weight?
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T2DM patients under follow-up of government health clinics Kuantan, Pahang.
- •Age between 20 - 65 years old.
- •Body Mass Index of more or equal to 23 kg/m
- •In the stage of pre-contemplation, contemplation, or preparation stage of change based on the S-weights questionnaire.
- •Able to understand, read and write in the Malay Language.
- •Have access to smartphone devices and internet services.
- •Have immediate family members (adults) who are living in the same household.
排除标准
- •Pregnant patients.
- •Patients' advanced comorbidity that will affect participation in the study protocol (e.g. vision problem, unable to walk or physically unfit to stand up, advanced heart failure, or cancer).
- •Patients with mental conditions which will affect understanding of the study protocol.
结局指标
主要结局
Changes of readiness to change for weight loss (behaviour)
时间窗: T0 (Week 0), T1 (Week 5), T2 (Week 9)
The stage of change for weight loss is based on the S-weight questionnaire (Transtheoretical Model). Data type: Categorical data (either in pre-contemplation, contemplation, preparation, or action stage)
次要结局
- Changes of decisional balance for weight loss (behaviour)(T0 (Week 0), T1 (Week 5), T2 (Week 9))
- Changes waist circumference (anthropometric)(T0 (Week 0), T1 (Week 5), T2 (Week 9))
- Changes in family support for healthy diet and physical activity to encourage weight loss (social support)(T0 (Week 0), T1 (Week 5), T2 (Week 9))
- Changes of self-efficacy for weight loss (behaviour)(T0 (Week 0), T1 (Week 5), T2 (Week 9))
- Changes body mass index (anthropometric)(T0 (Week 0), T1 (Week 5), T2 (Week 9))
- Changes in body fat composition (anthropometric)(T0 (Week 0), T1 (Week 5), T2 (Week 9))
研究者
Noraini Binti Mohd Saad
Principal Investigator
Universiti Teknologi Mara
研究点 (4)
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