Can a Physical Activity Skill Development and Parent-Centered Dietary Intervention Help Combat Child Obesity?
|ClinicalTrials.gov Identifier: NCT00107692|
Recruitment Status : Unknown
Verified September 2006 by University of Wollongong.
Recruitment status was: Active, not recruiting
First Posted : April 7, 2005
Last Update Posted : September 13, 2006
|Condition or disease||Intervention/treatment|
|Obesity||Behavioral: Physical activity and diet|
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The aim of this randomized controlled trial (RCT) is to evaluate and compare in overweight children the effectiveness of the following interventions:
1. a parent-centered dietary modification program; 2. a physical activity skill development program; and 3. a parent-centered dietary modification + physical activity skill development program.
We have successfully piloted two community-based conventional weight management programs, SHARK (a physical activity-based program) and PRAISE (a dietary modification program), suitable for use with overweight, pre-adolescent children, and propose that the combination of these two programs into a multi-component intervention has the potential to effectively treat child obesity. We hypothesize that at 6-, 12-, and 24-month follow-ups, compared to overweight children allocated to the physical activity only and dietary modification only groups, overweight children in the physical activity + dietary modification group will display a greater reduction in their adiposity and display improved metabolic profiles. Secondary analyses will determine if the combined intervention improves physical activity, sedentariness, energy intake, movement skills, self-esteem, and an activity of daily living.
Study design: An assessor-blinded randomized controlled trial.
Participants and their recruitment: 216 overweight children in Wollongong and Newcastle aged 6-9 years will be recruited. Each site will recruit 108 participants, 36 in each treatment arm. Recruitment will occur through the Media Units at both universities, through local GPs (general practitioners) and pediatricians.
Inclusion criteria: BMI (Body Mass Index) above international cut-off points for age and gender, one parent able to attend all required sessions, pre-pubertal, and no sibling enrolled.
Exclusion criteria: Extreme obesity (BMI SD [mean] score > 3.5), known syndromal causes of obesity, long term oral steroids, medications associated with weight gain, chronic illness, dietary restriction.
Allocation to groups: Computer-based random number-producing algorithm schedule.
Interventions: SHARK Physical activity skill development program. The “SHARK” program focuses on increasing the children's actual competence (or fundamental movement skills), perceived competence, and social support for physical activity. PRAISE parent-centered family weight management program. The PRAISE Program is a non-diet approach to healthy eating that aims to decrease overly restrictive eating and encourage eating in response to “true hunger”.
Assessment of outcome variables: assessed at baseline, 6-, 12-, and 24-month follow-ups.
Adiposity: BMI SD score, height, weight, and waist circumference. Metabolic profile measures: blood pressure; cholesterol, triglycerides; glucose and insulin.
Physical activity energy expenditure and sedentary activities: total kilocalories expended and time spent in sedentary activities.
Dietary energy intake: 4-day weighed food record (2 week days and the week-end), parent selection of lower fat items in the household grocery shopping and behavior changes related to a healthy lifestyle.
Actual and perceived competence: Test of Gross Motor Development and the Self-Perception Profile for Children.
Activity of daily living: Sit-to-stand transfer.
Statistical analyses: intention-to-treat analysis using the 12-month follow-up as the initial endpoint and 24-month follow-up as final data point.
Quality-assurance. Site bias, standardized and clearly defined protocols and retention strategies have been fully addressed.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||216 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of a Weight Management Program for Overweight and Obese Children: a Randomized Controlled Trial|
|Study Start Date :||March 2005|
|Estimated Study Completion Date :||October 2007|
- To evaluate and compare in overweight children the effectiveness of the following interventions: a parent-centered dietary modification program
- a physical activity skill development program
- and a parent-centered dietary modification + physical activity skill development program.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00107692
|Australia, New South Wales|
|University of Newcastle|
|Newcastle, New South Wales, Australia, 2308|
|Child Obesity Research Centre, University of Wollongong|
|Wollongong, New South Wales, Australia, 2522|
|Principal Investigator:||Tony D Okely, PhD, BEd||University of Wollongong|