UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020793 |
|---|---|
| Receipt number | 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 | 2024/02/06 14:19:03 |
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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
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
tanaka-hs@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health ans Developmnet
Institute
Department
Personal name
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
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
https://www.jstage.jst.go.jp/article/shokuiku/17/3/17_119/_article/-char/ja
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/shokuiku/17/3/17_119/_article/-char/ja
Number of participants that the trial has enrolled
26
Results
Comparing the mean change in obesity for children in the intervention and control groups, there was a 0.4% greater reduction in the intervention group. In children in the intervention group, energy, fat, and carbohydrate intake was reduced after the intervention. In addition, the intake of vegetables increased from pre-intervention levels. There were also changes in the children's lifestyle, especially in the intervention group.
Results date posted
| 2024 | Year | 02 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The subjects were recruited from among participants of the 'Screening for Lifestyle-related Diseases in Schoolchildren' conducted in Setagaya Ward from 2015 to 2018.
Participant flow
We administered a survey, tracked the number of daily steps, and collected anthropometric measurements at baseline and at 1 and 3 months after intervention. The intervention included the distribution of a workbook and logbook and was performed for a month.
Adverse events
Not applicable.
Outcome measures
Percentage of overweight
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2021 | Year | 04 | Month | 21 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 29 | Day |
Last modified on
| 2024 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023031
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| Registered date | File name |
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