Increasing physical activity in obese children

ISRCTN	ISRCTN58144540
DOI	https://doi.org/10.1186/ISRCTN58144540
Secondary identifying numbers	MCT-53574

Submission date: 01/09/2005
Registration date: 01/09/2005
Last edited: 11/12/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Gary Scott Goldfield
Scientific

Children's Hospital of Eastern Ontario
Research Institute
Ottawa, Ontario
K1H 8L1
Canada

Phone	+1 613 737 7600 ext. 3288
Email	ggoldfield@cheo.on.ca

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Quality of life
Scientific title
Study objectives	Compared to children with free access to targeted sedentary behaviors, children with contingent access to sedentary behavior will exhibit greater increases in physical activity, larger reductions in sedentary behaviors, and more favorable changes in fitness, body composition, diet, and motivation to be physically active.
Ethics approval(s)	Ethics approval received from the Children's Hospital of Eastern Ontario (CHEO) Research Ethics Board on the 11th June 2001.
Health condition(s) or problem(s) studied	Obesity
Intervention	Intervention: Contingent Group - The experimental (contingent) group is designed to increase child physical activity levels and decrease time spent in targeted sedentary behaviors by making access to sedentary activity contingent on physical activity. After data from activity monitors are downloaded, participants in the experimental contingent group will be told how much time they earned in each of the following two weeks for TV/VCR viewing and video games played via TV (e.g. Nintendo etc.). Parents will be taught how to program the TV allowance, which is an electronic device that records and helps budget TV/VCR viewing and video game playing. We acknowledge that targeted children may watch TV with parents or friends outside the house, or play computer games on a PC computer, and this will be measured by the concomitant use of self-report measures of sedentary activity. It is important to note that these potential sources of contamination also existed in previous clinical research that reduced access to TV viewing in obese children, and marked increases in physical activity were still obtained. Parents will be asked to implement the contingencies for two weeks beyond 12-week post-treatment to encourage physical activity between weeks 10 and 12, and this fading of contingency management may provide an opportunity for parents to implement their own contingencies. Control: Non-Contingent group - Participants in the non-contingent control group will also visit the laboratory bi-weekly to have their physical activity monitors downloaded. They will also be given a TV allowance for monitoring purposes (and to control for this device in the home), but parents will be explicitly told that children should have free access to targeted sedentary activities independent of physical activity. The control group is designed to control for contact with investigators, feedback on physical activity levels, passage of time, the effects of wearing the activity monitors, and the presence of the TV allowance in the home.
Intervention type	Other
Primary outcome measure	Physical activity, measured by pedometer counts.
Secondary outcome measures	1. Time in sedentary behaviour 2. Aerobic fitness (peak maximal oxygen consumption) 3. Body Mass Index (BMI) 4. Percent body fat (bioelectrical impedance and skinfold measurement) 5. Food intake and macronutrient composition 6. Motivation to be physically active (self-report)
Overall study start date	01/09/2002
Completion date	30/06/2004

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	8 Years
Upper age limit	12 Years
Sex	Both
Target number of participants	48
Key inclusion criteria	1. 8 - 12 year old children, either sex, who are overweight or obese defined as a Body Mass Index (BMI) above the 85th BMI percentile for age and sex (CDC, 2002) 2. Engaging in 15 hours of targeted sedentary behaviour per week, including TV/VCR/DVD use and video game playing 3. Engaging in less than 30 minutes of moderate to vigorous physical activity 4. No conditions that would limit physical activity 5. Agreement that the child or parent would not participate in any other exercise or weight control program during the course of the study 6. No regular participation in swimming or strength training because these activities cannot be measured properly by accelerometry 7. Willingness of the parents to enforce or maintain the contingencies or lack of as reflected by their assigned study group 8. Parent providing signed informed consent, and child providing signed informed assent
Key exclusion criteria	Children with developmental disabilities, who are often obese, will be excluded from participating in this initial trial in order to reduce the heterogeneity of the sample.
Date of first enrolment	01/09/2002
Date of final enrolment	30/06/2004

Locations

Countries of recruitment

Canada

Study participating centre

Children's Hospital of Eastern Ontario

Ottawa, Ontario
K1H 8L1
Canada

Sponsor information

Children's Hospital of Eastern Ontario (Canada)
Not defined

401 Smyth Road
Ottawa, Ontario
K1H 8L1
Canada

Website	http://www.cheo.on.ca/english/hub.shtml
"ROR"	https://ror.org/05nsbhw27

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-53574)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan