- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05428046
Preventing Eating Disorders by Improving Mental Health Literacy in Chinese Adolescents
July 3, 2022 updated by: Peking University
Preventing Eating Disorders by Improving Mental Health Literacy in Chinese Adolescents: A Non-randomized Cluster Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1395
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100871
- Peking University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Middle school students
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MHL intervention
Mental health literacy intervention for eating disorder
|
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.
|
Other: Waiting list
The waiting list group received MHL intervention at the end of 12 weeks follow-up assessment.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eating disorders mental health literacy
Time Frame: pre-intervention, post-intervention, 4 weeks follow-up, 12 weeks follow-up
|
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.
|
pre-intervention, post-intervention, 4 weeks follow-up, 12 weeks follow-up
|
social distance scale
Time Frame: pre-intervention, post-intervention, 4 weeks follow-up, 12 weeks follow-up
|
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.
|
pre-intervention, post-intervention, 4 weeks follow-up, 12 weeks follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight Concerns Scale
Time Frame: pre-intervention, post-intervention, 4 weeks follow-up, 12 weeks follow-up
|
The Weight Concerns Scale was used to assess weight concern and shape concern, with a higher score indicating more concerns.
|
pre-intervention, post-intervention, 4 weeks follow-up, 12 weeks follow-up
|
The SCOFF
Time Frame: pre-intervention, post-intervention, 4 weeks follow-up, 12 weeks follow-up
|
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).
|
pre-intervention, post-intervention, 4 weeks follow-up, 12 weeks follow-up
|
Actual help-seeking behavior
Time Frame: pre-intervention, post-intervention, 4 weeks follow-up, 12 weeks follow-up
|
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?".
|
pre-intervention, post-intervention, 4 weeks follow-up, 12 weeks follow-up
|
Patient Health Questionnaire-4
Time Frame: pre-intervention, post-intervention, 4 weeks follow-up, 12 weeks follow-up
|
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.
|
pre-intervention, post-intervention, 4 weeks follow-up, 12 weeks follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 18, 2021
Primary Completion (Actual)
June 5, 2022
Study Completion (Actual)
June 5, 2022
Study Registration Dates
First Submitted
June 16, 2022
First Submitted That Met QC Criteria
June 16, 2022
First Posted (Actual)
June 22, 2022
Study Record Updates
Last Update Posted (Actual)
July 7, 2022
Last Update Submitted That Met QC Criteria
July 3, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MHL-ED
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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