ChiCTR2100052752RecruitingUnknown
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
Not provided1 site in 1 country76 target enrollmentStarted: September 1, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Recruiting
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Body Weight
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- 随机平行对照
- Masking
- Assessor-blinded
Eligibility Criteria
- Ages
- 18 to 64 (—)
- Sex
- All
Inclusion Criteria
- •Chinese adults and aged from 18 to 64 years;
- •BMI >= 23 kg/m2;
- •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);
- •Able to read and write in Chinese, and able to understand Cantonese;
- •Mentally fit to provide consent as confirmed by attending psychiatrist;
- •Able to use apps installed on a smartphone (e.g., WeChat, Pedometer app).
Exclusion Criteria
- •Currently receiving enrolled in diet control and/or regular physical activity program;
- •Any physical impairment that barrier to participating in an exercise program;
- •Prior bariatric surgery;
- •Currently receiving cancer treatment;
- •Having the problem of harmful or dependent use of the substance;
- •Diagnosis of an eating disorder, including anorexia nervosa, bulimia nervosa, mental retardation or organic brain disorders;
- •Breastfeeding or being pregnant at recruitment.
Arms & Interventions
1
WALK-Beat-S Program
2
Standard Care
Outcomes
Primary Outcomes
Body Weight
Secondary Outcomes
- Waist Circumferences
- Blood Pressure
- Psychotic symptoms
- Dietary behaviour
- Physical activity level
Investigators
Study Sites (1)
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