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临床试验/NCT04708379
NCT04708379已完成不适用

Lifestyle Interventions for Overweight Adults With Severe Mental Illness in Shenzhen, China

Wuhan University1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
176
试验地点
1
主要终点
BMI

研究概览

简要总结

The purpose of this study is to examine the lifestyle intervention on life quality and mental health among overweight adults with severe mental illness in Shenzhen, China. A total of 210 overweight adults with severe mental illness will be randomly allocated to intervention group and control group. Participants in the intervention groups will receive a 10-month lifestyle intervention while the control group will be waitlisted. A group of investigators will measure the anthropocentric indicators, blood pressure, lifestyle, life quality, and mental health for all participants.

详细描述

Previous studies suggest that overweight is an important risk factor for life quality and mental health among patients with severe mental illness. Findings on Chinese adults regarding this issue are limited. Thus, we aim to assess the lifestyle intervention on life quality and mental health among overweight adults with severe mental illness in Shenzhen, China.

A total of 210 overweight adults with severe mental illness will be randomly allocated to two groups. Participants in the intervention groups will receive a 10-month lifestyle intervention while the control group will be waitlisted.

In the intervention group, participants will receive lifestyle education delivered by trained staffs from Wuhan university. The main objective of the lifestyle education is to raise participants' awareness regarding the health complications related to obesity and subsequently to promote weight loss through behavioural modifications. Participants will be advised to reduce energy intake by having three main meals and avoiding snacks; limiting intake of sugary food and beverages as well as fried and fatty foods; increasing intake of fruits and vegetables, etc. They will be asked to increase physical activity, aiming for a minimum 150 min of moderate-intensity exercise per week and/or 10,000 steps per day.

Outcome measurement include height, weight, blood pressure, dietary habits, sleep, physical activity, life quality, and mental health that will be measured by a group of trained investigator for all participants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-65 years
  • With severe mental illness
  • BMI>=24.0
  • Live in this district for 1 year at least.

排除标准

  • Disability
  • Refuse to participate
  • Pregnant woman
  • Severe chronic diseases, such as cancer.

结局指标

主要结局

BMI

时间窗: 12 weeks

Participants' height (in meters) and weight (in kilograms) will be measured by a group of investigators. weight and height will be combined to report BMI in kg/m\^2.

次要结局

  • Social support(12 weeks)
  • Life quality(12 weeks)
  • Depression(12 weeks)

研究者

发起方
Wuhan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Qiqiang He

Professor

Wuhan University

研究点 (1)

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