UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055004 |
|---|---|
| Receipt number | R000062839 |
| Scientific Title | Body weight and eating attitudes influence improvement of depressive symptoms n children and pre-adolescents with eating disorders: a prospective multicenter cohort study |
| Date of disclosure of the study information | 2024/07/22 |
| Last modified on | 2024/07/17 23:41:41 |
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Basic information
Public title
Depressive symptoms in children and pre-adolescents with eating disorders: a prospective multicenter cohort study
Acronym
Depressive symptoms and pediatric eating disorders
Scientific Title
Body weight and eating attitudes influence improvement of depressive symptoms n children and pre-adolescents with eating disorders: a prospective multicenter cohort study
Scientific Title:Acronym
Effects of weight and eating attitudes on depression in pediatric eating disorders
Region
| Japan |
Condition
Condition
Eating disorders
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate body weight, eating attitudes, psychosocial factors, and depression in children with eating disorders at the initial phase and to determine whether depressive symptoms improve prospectively with changes in as weight and eating behavior after treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in BMI-SD, ChEAT26, outcome scale, and CDI were assessed after 12 months of treatment.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 7 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The registration period lasted two years, from April 2014 to March 2016. Patients with eating disorders under the age of 16 were enrolled, and consent was obtained after the study protocol was explained to the patient and their guardians in the research manual.
Key exclusion criteria
Patients who did not provide informed consent to participate in this study were excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Suzuki |
Organization
Fukushima Medical University School of Medicine
Division name
Department of Pediatrics
Zip code
9601295
Address
1 Hikariga-oka, Fukushima, Fukushima 960-1295, Japan
TEL
0245471295
susan@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Suzuki |
Organization
Fukushima Medical University School of Medicine
Division name
Department of Pediatrics
Zip code
9601295
Address
1 Hikariga-oka, Fukushima, Fukushima 960-1295, Japan
TEL
0245471295
Homepage URL
susan@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
he Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Division of Medical Research Promotion
Address
1 Hikariga-oka, Fukushima, Fukushima 960-1295, Japan
Tel
0245471790
liaison@fmu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
13211
Org. issuing International ID_1
the medical ethics committee of Kurume University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 22 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/31528200/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/31528200/
Number of participants that the trial has enrolled
91
Results
After 12 months of treatment, depressive symptoms were evaluated in 62 of the 91 cases assessed initially. A paired-sample t-test showed a significant decrease in CDI scores after 12 months and a significant increase in BMI-SDS. Multiple regression analysis revealed that initial BMI-SDS and ChEAT26 scores were beneficial for CDI recovery. Additionally, initial BMI-SDS was useful for predicting BMI-SDS recovery after 12 months.
Results date posted
| 2024 | Year | 07 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The male to female ratio was 8:83, with females accounting for 93.4% of the cohort. The average BMI was 13.5 (SD: 1.6), and the average BMI-SDS was -3.5 (SD: 1.7). The free T3 levels, which reflect nutritional status, were low at 1.67 pg/mL (SD: 0.84). The prevalence of AN was 70.3% (64/91); the other 29.7% (27/91) were cases of ARFID, and the autism spectrum disorder comorbidity diagnosed based on DSM-5 criteria was 12.1% (11/91). The average ChEAT26 score was 20.7 points (SD: 15.5), and the outcome score was 15.7 points (SD: 4.5). The average CDI score was 17.5 points (SD: 8.5), with 24.2% of the cases exceeding the cutoff value (23/24) for Japanese children.
Participant flow
91 patients with eating disorders who had CDI at the initial visit (all patients), 62 patients who had CDI after 12 months of treatment (the follow-up group), and 29 patients who dropped out during the observation period (the dropout group)
Adverse events
no adverse events
Outcome measures
Changes in CDI score, BMI-SDS, ChEAT26 score, and outcome scale from the initial phase to the 12-month follow-up
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Among the 91 patients with eating disorders who had CDI at the initial visit (all patients), 62 patients who had CDI after 12 months of treatment (the follow-up group), and 29 patients who dropped out during the observation period (the dropout group), there were no significant differences in age at the initial visit, male-to-female ratio, BMI, and BMI-SDS, free T3 levels, the prevalence of AN and autism spectrum disorder comorbidity, the ChEAT26 score, the outcome score, and the CDI score.
Management information
Registered date
| 2024 | Year | 07 | Month | 17 | Day |
Last modified on
| 2024 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062839
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
