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【ChiCTR2100052752】The effectiveness of the Information-Motivation-Behavioural (IMB) based multimodal intervention (WALK-Beat-S) on anthropometric parameters, psychotic symptoms, physical activity levels and dietary behaviour of adults with schizophrenia: A pilot randomised controlled trial

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基本信息

登记号

ChiCTR2100052752

试验状态

正在进行

药物名称

药物类型

规范名称

首次公示信息日的期

2021-11-05

临床申请受理号

靶点

适应症

精神分裂症

试验通俗题目

The effectiveness of the Information-Motivation-Behavioural (IMB) based multimodal intervention (WALK-Beat-S) on anthropometric parameters, psychotic symptoms, physical activity levels and dietary behaviour of adults with schizophrenia: A pilot randomised controlled trial

试验专业题目

申办单位信息

申请人联系人

申请人名称

联系人邮箱

联系人邮编

852

联系人通讯地址

临床试验信息

试验目的

To examine the acceptability and feasibility of the information-behavioural-motivation (IMB) based multimodal intervention (WALK-Beat-S program) and to evaluate its potential effects on body weight (BW) (primary outcome), other anthropometric parameters, including waist circumferences (WC), systolic blood pressure (SBP) and diastolic blood pressure (DBP), psychotic symptoms, physical activity levels and dietary behaviour, of adults with schizophrenia who are overweight or obese, compared with standard care at immediate post-intervention and one-month post-intervention.

试验分类

试验类型

随机平行对照

试验分期

探索性研究/预试验

随机化

Participants will be randomly allocated into an intervention group (WALK-Beat-S program) or a control group (standard care) by using block randomisation on a 1:1 ratio, with a block size of six and eight. A clerical staff independent from the study will generate random codes by a random allocation software.

盲法

Assessor-blinded

试验项目经费来源

N/A

试验范围

目标入组人数

实际入组人数

第一例入组时间

2021-09-01

试验终止时间

2022-09-30

是否属于一致性

入选标准

1. Chinese adults and aged from 18 to 64 years; 2. BMI >= 23 kg/m2; 3. Have been diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) or 5th edition (DSM-V), or the International Statistical Classification of Diseases and Related Health Problem, 10th Revision (ICD-10); 4. Able to read and write in Chinese, and able to understand Cantonese; 5. Mentally fit to provide consent as confirmed by attending psychiatrist; 6. Able to use apps installed on a smartphone (e.g., WeChat, Pedometer app).；

排除标准

1. Currently receiving enrolled in diet control and/or regular physical activity program; 2. Any physical impairment that barrier to participating in an exercise program; 3. Prior bariatric surgery; 4. Currently receiving cancer treatment; 5. Having the problem of harmful or dependent use of the substance; 6. Diagnosis of an eating disorder, including anorexia nervosa, bulimia nervosa, mental retardation or organic brain disorders; 7. Breastfeeding or being pregnant at recruitment.；

研究者信息

研究负责人姓名

试验机构

N/A

研究负责人电话

研究负责人邮箱

研究负责人邮编

852

联系人通讯地址

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