Lifestyle Interventions for Overweight Adults With Mental Illness

Overview

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.

Full Title of Study: “Lifestyle Interventions for Overweight Adults With Severe Mental Illness in Shenzhen, China”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 31, 2021

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.

Interventions

  • Behavioral: Lifestyle intervention
    • Nutrition and physical activity education.

Arms, Groups and Cohorts

  • Experimental: Intervention group
    • Nutrition education and physical activity education.
  • No Intervention: Control group
    • No specific intervention.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Life quality
    • Time Frame: 12 weeks
    • Life quality will be investigated by the short form version of the quality of life enjoyment and satisfaction questionnaire (Q-LES-Q-SF). Each item uses a 5-point scale ranging from 1 (very poor) to 5 (very good). A total score is derived from 14 items with a maximum score of 70 and with higher scores indicating greater life satisfaction and enjoyment.
  • Depression
    • Time Frame: 12 weeks
    • Depression will be assessed by Center for Epidemiological Studies Depression Scale (CES-D). This is a 20-item measure that asks participants to rate how often over the past week they experienced symptoms associated with depression. Response options range from 0 to 3 for each item. Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
  • Social support
    • Time Frame: 12 weeks
    • Social support will be assessed by Perceived social support scale(PSSS). The scale consists of 12 items, including family support, friend support and other support. The higher the score of Liker-7 points, the higher the level of social support perceived by the individual.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Wuhan University
  • Collaborator
    • Centers for Disease Control and Prevention
  • Provider of Information About this Clinical Study
    • Principal Investigator: Qiqiang He, Professor – Wuhan University
  • Overall Official(s)
    • Qiqiang He, PhD, Principal Investigator, Wuhan University
  • Overall Contact(s)
    • Qiqiang He, PhD, 862768758648, 4657473@qq.com

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