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NCT Number: NCT04708379

Lifestyle Interventions for Overweight Adults With Mental Illness

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.

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Key information

Conditions

Mental Health Disorder Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pingshan CDC

Shenzhen, Guangdong, 518118, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lifestyle Intervention

Behavioral

Nutrition and physical activity education.

Primary outcomes

  1. BMI

    Time frame: 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 outcomes

  1. Life quality

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. BP

    Time frame: 12 weeks

    Blood pressure (measured by a group of investigators)

  2. Sleep

    Time frame: 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

    Time frame: 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

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

Wuhan University

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jan 13, 2021
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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