Clinical trial NCT04708379: Lifestyle Interventions for Overweight Adults With Mental Illness
Official title: Lifestyle Interventions for Overweight Adults With Severe Mental Illness in Shenzhen, China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Disorder
Lead sponsor: Wuhan University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2021-01-13
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: BMI
timeFrame: 12 weeks
Secondary outcomes:
measure: Life quality
timeFrame: 12 weeks
measure: Depression
timeFrame: 12 weeks
measure: Social support
timeFrame: 12 weeks
Other outcomes:
measure: BP
timeFrame: 12 weeks
measure: Sleep
timeFrame: 12 weeks
measure: Physical activity
timeFrame: 12 weeks
measure: Diet
timeFrame: 12 weeks
Locations:
city: Shenzhen
country: China
facility: Pingshan CDC
state: Guangdong
Study officials:
affiliation: Wuhan University
name: Qiqiang He, PhD
role: PRINCIPAL_INVESTIGATOR
References: