NCT04708379

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

January 3, 2021

Last Update Submit

May 16, 2022

Conditions

Mental Health Disorder

Outcome Measures

Primary Outcomes (1)

  • BMI

    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.

    12 weeks

Secondary Outcomes (3)

  • Life quality

    12 weeks

  • Depression

    12 weeks

  • Social support

    12 weeks

Other Outcomes (4)

  • BP

    12 weeks

  • Sleep

    12 weeks

  • Physical activity

    12 weeks

  • +1 more other outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Nutrition education and physical activity education.

Behavioral: Lifestyle intervention

Control group

NO INTERVENTION

No specific intervention.

Interventions

Lifestyle interventionBEHAVIORAL

Nutrition and physical activity education.

Intervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pingshan CDC

Shenzhen, Guangdong, 518118, China

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Qiqiang He, PhD

    Wuhan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 3, 2021

First Posted

January 13, 2021

Study Start

January 1, 2021

Primary Completion

June 30, 2021

Study Completion

January 1, 2022

Last Updated

May 17, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)