Eating DisordersNCT05428046
Preventing Eating Disorders by Improving Mental Health Literacy in Chinese Adolescents
A study testing MHL intervention and Waiting list in people with Eating Disorders and Mental Health Literacy, run by Peking University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Eating Disorders, Mental Health Literacy
- What is being tested?
- MHL intervention and Waiting list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,395 participants
- Where
- 1 siteChina
- Study dates
- 18 Nov 2021to 5 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Middle school students
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Eating Disorders, Mental Health Literacy
- Being tested
- MHL intervention, Waiting list
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MHL interventionBehavioural
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.
Waiting listBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MHL intervention | Experimental | Mental health literacy intervention for eating disorder Receives: Behavioral: MHL intervention |
| Waiting list | Other | The waiting list group received MHL intervention at the end of 12 weeks follow-up assessment. Receives: Behavioral: Waiting list |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-intervention, post-intervention, 4 weeks follow-up, 12 weeks follow-up
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.
Measured: pre-intervention, post-intervention, 4 weeks follow-up, 12 weeks follow-up
Secondary outcomes (4)
Weight Concerns Scale
The Weight Concerns Scale was used to assess weight concern and shape concern, with a higher score indicating more concerns.
Measured: pre-intervention, post-intervention, 4 weeks follow-up, 12 weeks follow-up
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).
Measured: pre-intervention, post-intervention, 4 weeks follow-up, 12 weeks follow-up
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?".
Measured: pre-intervention, post-intervention, 4 weeks follow-up, 12 weeks follow-up
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.
Measured: pre-intervention, post-intervention, 4 weeks follow-up, 12 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start18 Nov 2021
- Primary completion5 Jun 2022
- Study completion5 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,395 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428046
- Sponsor's protocol ID
- MHL-ED
- Status last verified
- Jul 2022
- First submitted
- 16 Jun 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Eating Disorders by Improving Mental Health Literacy in Chinese Adolescents: A Non-randomized Cluster Controlled Trial
- ClinicalTrials.gov ID
- NCT05428046
- Acronym / sponsor ID
- MHL-ED
- Conditions
- Eating Disorders, Mental Health Literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,395 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 5 Jun 2022 (actual)
- Study completion
- 5 Jun 2022 (actual)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MHL intervention | Experimental | Behavioral: MHL interventionMental health literacy intervention for eating disorder |
| Waiting list | Other | Behavioral: Waiting listThe waiting list group received MHL intervention at the end of 12 weeks follow-up assessment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Middle school students
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MHL interventionThe 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. | Behavioural | MHL intervention |
| Waiting listParticipants 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. | Behavioural | Waiting list |
Primary outcome
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.
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.
4 secondary outcomes
Weight Concerns Scale
Time frame: 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
Actual help-seeking behavior
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MHL intervention and Waiting list in people with Eating Disorders and Mental Health Literacy, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating disorders mental health literacy (time frame: pre-intervention, post-intervention, 4 weeks follow-up, 12 weeks follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.