Can a Physical Activity Skill Development and Parent-Centered Dietary Intervention Help Combat Child Obesity?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by University of Wollongong.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Newcastle University
University of Sydney
Illawarra Area Health Services
Information provided by:
University of Wollongong
ClinicalTrials.gov Identifier:
NCT00107692
First received: April 6, 2005
Last updated: September 11, 2006
Last verified: September 2006

April 6, 2005
September 11, 2006
March 2005
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  • 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.
Same as current
Complete list of historical versions of study NCT00107692 on ClinicalTrials.gov Archive Site
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Can a Physical Activity Skill Development and Parent-Centered Dietary Intervention Help Combat Child Obesity?
Effect of a Weight Management Program for Overweight and Obese Children: a Randomized Controlled Trial

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.

AIMS

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.

BACKGROUND

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.

RESEARCH PLAN

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
Behavioral: Physical activity and diet
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
216
October 2007
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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

Exclusion Criteria:

  • Children with BMI outside the specified range
  • Children on medication that may influence obesity
  • Children that have conditions that may influence obesity
Both
66 Months to 9 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00107692
NHMRC Project Grant 354101
Not Provided
Not Provided
University of Wollongong
  • Newcastle University
  • University of Sydney
  • Illawarra Area Health Services
Principal Investigator: Tony D Okely, PhD, BEd University of Wollongong
University of Wollongong
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP