Lifestyle Interventions for Overweight Adults With Mental Illness

NCT ID: NCT04708379

Last Updated: 2022-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-01-01

Brief Summary

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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

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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.

Conditions

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Mental Health Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention group

Nutrition education and physical activity education.

Group Type EXPERIMENTAL

Lifestyle intervention

Intervention Type BEHAVIORAL

Nutrition and physical activity education.

Control group

No specific intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lifestyle intervention

Nutrition and physical activity education.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Wuhan University

OTHER

Sponsor Role lead

Responsible Party

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Qiqiang He

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qiqiang He, PhD

Role: PRINCIPAL_INVESTIGATOR

Wuhan University

Locations

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Pingshan CDC

Shenzhen, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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Pingshan Mental Health Study

Identifier Type: -

Identifier Source: org_study_id

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