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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015622
Receipt No. 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 2014/11/07

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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
Last name of lead principal investigator
1st name
Middle name
Last name Dirk E. Bock MD
Organization Children's Hospital, London Health Sciences Centre, University of Western Ontario
Division name Pediatrics
Zip code
Address 800 Commissioners Rd E. London, Ontario, N6A 5W9, Canada
TEL 5196858500
Email dirk.bock@lhsc.on.ca

Public contact
1st name of contact person
1st name
Middle name
Last name Tracy Robinson
Organization Children's Hospital, London Health Sciences Centre
Division name Pediatrics
Zip code
Address 800 Commissioners Rd E. London, Ontario, N6A 5W9, Canada
TEL 5196858500(ext.57130)
Homepage URL
Email tracy.robinson@lhsc.on.ca

Sponsor
Institute Lawson Health Research Institute (incorporated as London Health Sciences Centre Research Inc.)
Institute
Department

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
Address
Tel
Email

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
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Poster presented at the Canadian Obesity Summit, Vancouver B.C., Canada (May 1-4, 2013). 
Publication in peer-reviewed journal pending, manuscript re-submitted for consideration.
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
2009 Year 01 Month 20 Day
Date of IRB
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
2014 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018134

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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