UMIN-CTR Clinical Trial

Basic information
Public title	Psycho-social predictors of recovery in patients with eating disorder: a cohort study
Acronym	Recovery of eating disorder with patient and mother
Scientific Title	Psycho-social predictors of recovery in patients with eating disorder: a cohort study
Scientific Title:Acronym	Recovery of eating disorder with patient and mother
Region	Japan

Condition
Condition	Eating diorder
Classification by specialty	Psychiatry Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to examine whether the recuction of mother's loneliness contribute improving ED symptoms of patients with ED.
Basic objectives2	Others
Basic objectives -Others	The aim of this study is to examine whether the recuction of mother's loneliness contribute improving ED symptoms of patients with ED.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The reduction of mother's loneliness measured by UCLA loneliness scale contribute improving ED symptoms of patients with ED measured by Eating Disorder Inventory.
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	16 years-old <=
Age-upper limit	50 years-old >=
Gender	Female
Key inclusion criteria	The participant are patients with eating disorder and their mothers. Inclusion criteria are: the patient met the criteria for eating disorder; patients are inpatients, outpatients and in the treatment interruption; the patients are aged between 16 and 50 years; the mothers are aged between 30 and 85 years.
Key exclusion criteria	They con not read or write in Japanese
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Middle name Last name Fujika Katsuki
Organization	Nagoya City University
Division name	School of Nursing
Zip code
Address	Kawasumi 1, Mizuho-ku, Misuho-cho, Nagoya
TEL	052-853-8048
Email	katsuki@med.nagoya-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Fujika Katsuki
Organization	Nagoya City University
Division name	School of Nursing
Zip code
Address	Kawasumi 1, Mizuho-ku, Misuho-cho, Nagoya
TEL	052-853-8048
Homepage URL
Email	katsuki@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University
Institute
Department

Funding Source
Organization	Ministry of Education, Science, and Technology
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
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 10 Day
Date of IRB	2017 Year 05 Month 15 Day
Anticipated trial start date	2017 Year 07 Month 19 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Assessment (Patients) Self esteem Loneliness Assertion Eating disorder symptoms Family function Assessment (Mothers) Social support Self-efficacy Loneliness Active listening Depression Mental Health

Management information
Registered date	2018 Year 03 Month 13 Day
Last modified on	2020 Year 09 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036152