Lifestyle Interventions for Overweight Adults With Mental Illness

Mental Health Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04708379
• Other study ID #: Pingshan Mental Health Study
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: May 2022
• Source: Wuhan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: January 1, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Mental Health Disorder
• Overweight

Intervention

Behavioral:
• Lifestyle intervention
Nutrition and physical activity education.

Locations

Country	Name	City	State
China	Pingshan CDC	Shenzhen	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Wuhan University	Centers for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	BP	Blood pressure (measured by a group of investigators)	12 weeks
Other	Sleep	Sleep status will be assessed by Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-report questionnaire consisting of 19 items and five additional questions. The 19 items are combined to form seven sleep quality component scores. Each component score can range from 0 to 3. The seven component scores are summed to yield a global PSQI score ranging from 0 to 21, with higher scores indicate poorer sleep quality.	12 weeks
Other	Physical activity	Physical activity will be assessed by International Physical Activity Questionnaire (IPAQ). This IPAQ consists of seven questions assessing the frequency and duration of participation in vigorous, moderate-intensity, and walking activity as well as the time spent sitting during a weekday. The sum of the three activity scores gives an indicator of total physical activity.	12 weeks
Other	Diet	Participants self-report their dietary intake including rice, meat, milk, fruits, vegetable, etc using a short food frequency questionnaire.	12 weeks
Primary	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	Life quality	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.	12 weeks
Secondary	Depression	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.	12 weeks
Secondary	Social support	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.	12 weeks