UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015622 |
|---|---|
| Receipt number | R000018134 |
| Scientific Title | The Health Initiative Program for Kids (HIP Kids): 1-year multidisciplinary lifestyle intervention on adiposity and quality of life in obese children and adolescents |
| Date of disclosure of the study information | 2014/11/07 |
| Last modified on | 2019/06/03 23:13:03 |
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Basic information
Public title
The Health Initiative Program for Kids (HIP Kids): 1-year multidisciplinary lifestyle intervention on adiposity and quality of life in obese children and adolescents
Acronym
The HIP Kids Program
Scientific Title
The Health Initiative Program for Kids (HIP Kids): 1-year multidisciplinary lifestyle intervention on adiposity and quality of life in obese children and adolescents
Scientific Title:Acronym
The HIP Kids Program
Region
| North America |
Condition
Condition
Pediatric Obesity
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this pilot study is to prospectively evaluate whether HIP Kids, a 1-year, multidisciplinary, family-centred, hospital-based, outpatient intervention for obese children and adolescents 8-17 years of age and their families, is effective in preventing further increase in body mass index (BMI) and BMI standard deviation score (BMI z-score), and in improving QoL.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in BMI and BMI z-score
Key secondary outcomes
Change in health-related quality of life, body composition (% body fat, fat-ree mass, waist circumference), physical activity score (Physical Activity Questionnaires for children and adolescents); cost of intervention per patient.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The 1-year multidisciplinary intervention consisted of an initial 3-month intensive phase with bi-weekly individual counseling sessions, followed by a 9-month maintenance phase with alternating monthly individual or group sessions. Each of the 15 sessions was 90 minutes in length and was divided into three 30-minute educational blocks focusing on nutrition, physical activity, and psychosocial and behavioural aspects, led by a dietitian, exercise specialist, and social worker. Assessments were performed at baseline, at 3 months and 12 months.
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
| 8 | years-old | < |
Age-upper limit
| 17 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Physician-referred children and adolescents 8-17 years of age with primary obesity (BMI, calculated as weight in kilograms divided by height in meters squared, at or above the 95th percentile for age and sex, Centers for Disease Control and Prevention October 2000 growth charts)
Key exclusion criteria
Age or BMI outside of the specified range, lack of committment of at least one caregiver willing to participate in the program sessions.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Dirk |
| Middle name | E. |
| Last name | Bock |
Organization
Children's Hospital, London Health Sciences Centre, University of Western Ontario
Division name
Pediatrics
Zip code
N6A5W9
Address
800 Commissioners Rd E. London, Ontario, N6A 5W9, Canada
TEL
5196858500
dirk.bock@lhsc.on.ca
Public contact
Name of contact person
| 1st name | Tracy |
| Middle name | |
| Last name | Robinson |
Organization
Children's Hospital, London Health Sciences Centre
Division name
Pediatrics
Zip code
N6A5W9
Address
800 Commissioners Rd E. London, Ontario, N6A 5W9, Canada
TEL
5196858500
Homepage URL
tracy.robinson@lhsc.on.ca
Sponsor or person
Institute
Lawson Health Research Institute (incorporated as London Health Sciences Centre Research Inc.)
Institute
Department
Personal name
Funding Source
Organization
Children's Health Foundation, London, Ontario, Canada
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Canada
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office of Research Ethics, Western University
Address
Western University, London, Ontario, Canada
Tel
5196613036
ethics@uwo.ca
Secondary IDs
Secondary IDs
YES
Study ID_1
4523
Org. issuing International ID_1
Office of Research Ethics, Western University, London, Ontario, Canada
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Children's Hospital, London Health Sciences Centre, University of Western Ontario
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 07 | Day |
Related information
URL releasing protocol
Study completed 2012
Publication of results
Published
Result
URL related to results and publications
https://bmcpediatr.biomedcentral.com/articles/10.1186/s12887-014-0296-1
Number of participants that the trial has enrolled
88
Results
See publication.
Results date posted
| 2019 | Year | 06 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
See publication.
Participant flow
See publication.
Adverse events
None.
Outcome measures
See publication.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2008 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2009 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2012 | Year | 04 | Month | 12 | Day |
Date of closure to data entry
| 2012 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
| 2012 | Year | 08 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 07 | Day |
Last modified on
| 2019 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018134
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