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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020793
Receipt No. R000023031
Scientific Title Family intervention program with a focus on paternal role based on the social cognitive theory for treatment of obese children: a randomized controlled trial
Date of disclosure of the study information 2016/01/30
Last modified on 2021/08/03

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Basic information
Public title Family intervention program with a focus on paternal role based on the social cognitive theory for treatment of obese children: a randomized controlled trial
Acronym Family intervention program with a focus on paternal role for treatment of obese children
Scientific Title Family intervention program with a focus on paternal role based on the social cognitive theory for treatment of obese children: a randomized controlled trial
Scientific Title:Acronym Family intervention program with a focus on paternal role for treatment of obese children
Region
Japan

Condition
Condition Childhood obesity
Classification by specialty
Endocrinology and Metabolism Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the operability, continuity, satisfaction and effectiveness of a family intervention program (non-face-to-face) which put emphasis on father's role, based on the social cognitive theory for the obese children by randomized controlled trial in Setagaya-ku, Tokyo, Japan.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Children's degree of obesity at 3-month follow-up
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 1. Intervention group
After an explanatory meeting, both parents and their children start the intervention program based on social recognition theory at home for one month.
(1) After an explanatory meeting, they learn diet and lifestyle improvement methods for weight management along with workbook provided.
(2) They perform own evaluation using checklist provided in the logbook.
(3) During the one month intervention, they perform self-monitoring such as lifestyle, weight and steps in every day, and homework involve both father and their children.
Interventions/Control_2 2. Control group
After an explanatory meeting, they learn diet and lifestyle the improvement methods for weight management with only workbook.
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
6 years-old <=
Age-upper limit
16 years-old >
Gender Male and Female
Key inclusion criteria 1 children
(1) Age:6-16years old
degree of obesity: 20%or more
(2) They live with their parents.
(3) They agree to join this research by document.
2 parents
(1) They live with their children.
(2) They agree to join this research by document.
Key exclusion criteria 1 children
(1) They're using the medicine which influences the weight.
(2) They're handicapped physically or developmentally.
(3) They have some underlying diseases.
2 parents
(1) They're using the medicine which influences the weight.
(2) They have some underlying diseases.
(3) There is a problem with that they answer to a questionnaire, exercise and make a meal in homework.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Hisako
Middle name
Last name TANAKA
Organization National Center for Child Health and Development
Division name Department of Social Medicine
Zip code 157-8535
Address #2-10-1, Okura, Setagaya-ku, Tokyo 157-8535, Japan
TEL 03-3417-2647
Email tanaka-hs@ncchd.go.jp

Public contact
Name of contact person
1st name Hisako
Middle name
Last name TANAKA
Organization National Center for Child Health and Development
Division name Department of Social Medicine
Zip code 157-8535
Address #2-10-1, Okura, Setagaya-ku, Tokyo 157-8535, Japan
TEL 03-3417-2647
Homepage URL
Email tanaka-hs@ncchd.go.jp

Sponsor
Institute National Center for Child Health ans Developmnet
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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 National Center for Child Health ans Developmnet
Address #2-10-1, Okura, Setagaya-ku, Tokyo 157-8535, Japan
Tel 03-3416-0181
Email rinri@ncchd.go.jp

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
2016 Year 01 Month 30 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 No longer recruiting
Date of protocol fixation
2015 Year 11 Month 16 Day
Date of IRB
2015 Year 11 Month 16 Day
Anticipated trial start date
2016 Year 01 Month 10 Day
Last follow-up date
2019 Year 06 Month 30 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 29 Day
Last modified on
2021 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023031

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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