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Clinical Trials/NCT04708379
NCT04708379
Completed
Not Applicable

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

Wuhan University1 site in 1 country176 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mental Health Disorder
Sponsor
Wuhan University
Enrollment
176
Locations
1
Primary Endpoint
BMI
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
January 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Wuhan University
Responsible Party
Principal Investigator
Principal Investigator

Qiqiang He

Professor

Wuhan University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

BMI

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

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