Preventing Eating Disorders by Improving Mental Health Literacy in Chinese Adolescents
Primary Purpose
Eating Disorders, Mental Health Literacy
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MHL intervention
Waiting list
Sponsored by
About this trial
This is an interventional prevention trial for Eating Disorders
Eligibility Criteria
Inclusion Criteria:
- Middle school students
Exclusion Criteria:
-
Sites / Locations
- Peking University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
MHL intervention
Waiting list
Arm Description
Mental health literacy intervention for eating disorder
The waiting list group received MHL intervention at the end of 12 weeks follow-up assessment.
Outcomes
Primary Outcome Measures
Eating disorders mental health literacy
The vignette for eating disorders mental health literacy was developed for the current study. The vignette describes a 14-year old girl who has bulimia nervosa. We also conducted a 5-point Likert scale to assess the knowledge, attitude, and help-seeking behaviors of eating disorders. Higer scores indicating a higer level of eating disorders mental health literacy.
social distance scale
The social distance scale was used to assess the level of social rejection that participants were likely to impose on people with eating disorders. The lower the score, the greater the desire for social distancing and the more negative the attitude toward people with eating disorders.
Secondary Outcome Measures
Weight Concerns Scale
The Weight Concerns Scale was used to assess weight concern and shape concern, with a higher score indicating more concerns.
The SCOFF
The SCOFF (Sick, Control, One, Fat, Food) was used to detect the existence of eating disorder symptoms. Scores of 2 or greater were originally set a cut-off point for maximum sensitivity to detect anorexia and Bulimia nervosa (Morgan et al, 1999).
Actual help-seeking behavior
We conducetd three items to assess the actual help-seeking behavior, including, "In the last 6 months, have you come into contact with someone who you think may have the same problems as Lily?","Have you offered help to them?", "How you helped him/her?".
Patient Health Questionnaire-4
The Patient Health Questionnaire-4 was used to assess any negative impact on participant's well-being. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05428046
Brief Title
Preventing Eating Disorders by Improving Mental Health Literacy in Chinese Adolescents
Official Title
Preventing Eating Disorders by Improving Mental Health Literacy in Chinese Adolescents: A Non-randomized Cluster Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 18, 2021 (Actual)
Primary Completion Date
June 5, 2022 (Actual)
Study Completion Date
June 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Mental health literacy (MHL) is necessary for the prevention, detection, and treatment of eating disorders, whereas the MHL about eating disorders is inadequate in China. Thus, the current study aimed to improve the MHL for eating disorders among Chinese adolescents via a brief online intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders, Mental Health Literacy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1395 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MHL intervention
Arm Type
Experimental
Arm Description
Mental health literacy intervention for eating disorder
Arm Title
Waiting list
Arm Type
Other
Arm Description
The waiting list group received MHL intervention at the end of 12 weeks follow-up assessment.
Intervention Type
Behavioral
Intervention Name(s)
MHL intervention
Intervention Description
The current MHL intervention is a brief online intervention and comprises two modules. The first module is a short video introducing a teenage girl with bulimia nervosa. The second module is an online lecture comprising information about eating disorders including the prevalence, symptoms, type, cause, treatment, a related symptom checker, and sources of help. The above two modules are implemented in a single session lasting approximately 2 hours.
Intervention Type
Behavioral
Intervention Name(s)
Waiting list
Intervention Description
Participants assigned to the waiting list group will not receive any intervention until the end of the 12 weeks follow-up. They received the same intervention as the MHL intervention group after the 12 weeks follow-up test.
Primary Outcome Measure Information:
Title
Eating disorders mental health literacy
Description
The vignette for eating disorders mental health literacy was developed for the current study. The vignette describes a 14-year old girl who has bulimia nervosa. We also conducted a 5-point Likert scale to assess the knowledge, attitude, and help-seeking behaviors of eating disorders. Higer scores indicating a higer level of eating disorders mental health literacy.
Time Frame
pre-intervention, post-intervention, 4 weeks follow-up, 12 weeks follow-up
Title
social distance scale
Description
The social distance scale was used to assess the level of social rejection that participants were likely to impose on people with eating disorders. The lower the score, the greater the desire for social distancing and the more negative the attitude toward people with eating disorders.
Time Frame
pre-intervention, post-intervention, 4 weeks follow-up, 12 weeks follow-up
Secondary Outcome Measure Information:
Title
Weight Concerns Scale
Description
The Weight Concerns Scale was used to assess weight concern and shape concern, with a higher score indicating more concerns.
Time Frame
pre-intervention, post-intervention, 4 weeks follow-up, 12 weeks follow-up
Title
The SCOFF
Description
The SCOFF (Sick, Control, One, Fat, Food) was used to detect the existence of eating disorder symptoms. Scores of 2 or greater were originally set a cut-off point for maximum sensitivity to detect anorexia and Bulimia nervosa (Morgan et al, 1999).
Time Frame
pre-intervention, post-intervention, 4 weeks follow-up, 12 weeks follow-up
Title
Actual help-seeking behavior
Description
We conducetd three items to assess the actual help-seeking behavior, including, "In the last 6 months, have you come into contact with someone who you think may have the same problems as Lily?","Have you offered help to them?", "How you helped him/her?".
Time Frame
pre-intervention, post-intervention, 4 weeks follow-up, 12 weeks follow-up
Title
Patient Health Questionnaire-4
Description
The Patient Health Questionnaire-4 was used to assess any negative impact on participant's well-being. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression.
Time Frame
pre-intervention, post-intervention, 4 weeks follow-up, 12 weeks follow-up
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Middle school students
Exclusion Criteria:
-
Facility Information:
Facility Name
Peking University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100871
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Preventing Eating Disorders by Improving Mental Health Literacy in Chinese Adolescents
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