Can a Physical Activity Skill Development and Parent-Centered Dietary Intervention Help Combat Child Obesity?
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|First Submitted Date ICMJE||April 6, 2005|
|First Posted Date ICMJE||April 7, 2005|
|Last Update Posted Date||September 13, 2006|
|Study Start Date ICMJE||March 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00107692 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Can a Physical Activity Skill Development and Parent-Centered Dietary Intervention Help Combat Child Obesity?|
|Official Title ICMJE||Effect of a Weight Management Program for Overweight and Obese Children: a Randomized Controlled Trial|
|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.|
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 ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Intervention ICMJE||Behavioral: Physical activity and diet|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date||October 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||66 Months to 9 Years (Child)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Australia|
|Removed Location Countries|
|NCT Number ICMJE||NCT00107692|
|Other Study ID Numbers ICMJE||NHMRC Project Grant 354101|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University of Wollongong|
|PRS Account||University of Wollongong|
|Verification Date||September 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP