Lifestyle Interventions for Overweight Adults With Mental Illness

Sponsor
Wuhan University (Other)
Overall Status
Completed
CT.gov ID
NCT04708379
Collaborator
Centers for Disease Control and Prevention (U.S. Fed)
176
1
2
12
14.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Lifestyle intervention
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
176 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Lifestyle Interventions for Overweight Adults With Severe Mental Illness in Shenzhen, China
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Jan 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

Nutrition education and physical activity education.

Behavioral: Lifestyle intervention
Nutrition and physical activity education.

No Intervention: Control group

No specific intervention.

Outcome Measures

Primary Outcome Measures

  1. BMI [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 Outcome Measures

  1. Life quality [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.

  2. Depression [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.

  3. Social support [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.

Other Outcome Measures

  1. BP [12 weeks]

    Blood pressure (measured by a group of investigators)

  2. Sleep [12 weeks]

    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.

  3. Physical activity [12 weeks]

    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.

  4. Diet [12 weeks]

    Participants self-report their dietary intake including rice, meat, milk, fruits, vegetable, etc using a short food frequency questionnaire.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pingshan CDC Shenzhen Guangdong China 518118

Sponsors and Collaborators

  • Wuhan University
  • Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Qiqiang He, PhD, Wuhan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Qiqiang He, Professor, Wuhan University
ClinicalTrials.gov Identifier:
NCT04708379
Other Study ID Numbers:
  • Pingshan Mental Health Study
First Posted:
Jan 13, 2021
Last Update Posted:
May 17, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2022