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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00107692




Registration number
NCT00107692
Ethics application status
Date submitted
6/04/2005
Date registered
7/04/2005
Date last updated
13/09/2006

Titles & IDs
Public title
Can a Physical Activity Skill Development and Parent-Centered Dietary Intervention Help Combat Child Obesity?
Scientific title
Effect of a Weight Management Program for Overweight and Obese Children: a Randomized Controlled Trial
Secondary ID [1] 0 0
NHMRC Project Grant 354101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Physical activity and diet

Behaviour: Physical activity and diet
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate and compare in overweight children the effectiveness of the following interventions: a parent-centered dietary modification program
Timepoint [1] 0 0
Primary outcome [2] 0 0
a physical activity skill development program
Timepoint [2] 0 0
Primary outcome [3] 0 0
and a parent-centered dietary modification + physical activity skill development program.
Timepoint [3] 0 0

Eligibility
Key inclusion criteria
- Overweight and obese children with the Wollongong and Newcastle regions, aged between
5.5 and 9

- BMI within specified range

- Otherwise healthy children

- Not on any medications that may influence obesity

- One parent able to attend all required sessions

- Pre-pubertal

- No sibling enrolled
Minimum age
66 Months
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Children with BMI outside the specified range

- Children on medication that may influence obesity

- Children that have conditions that may influence obesity

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of Newcastle - Newcastle
Recruitment hospital [2] 0 0
Child Obesity Research Centre, University of Wollongong - Wollongong
Recruitment postcode(s) [1] 0 0
2308 - Newcastle
Recruitment postcode(s) [2] 0 0
2522 - Wollongong

Funding & Sponsors
Primary sponsor type
Other
Name
University of Wollongong
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Newcastle University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Sydney
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Illawarra Area Health Services
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study, and its original contribution to research, is to determine the
impact of a physical activity skill development and parent centered family weight management
program on the weight, cardiovascular health, physical activity, dietary intake and sedentary
behaviors of overweight and obese children.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00107692
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tony D Okely, PhD, BEd
Address 0 0
University of Wollongong
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00107692