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.

Condition	Treatment or Intervention
Obesity	Behavior: Physical activity and diet

Further Study Details: 

Primary Outcomes: 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.
Expected Total Enrollment:  216

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 practictioners) 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.

Ages Eligible for Study:  66 Months   -   9 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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

Tony D Okely, PhD,      +61 2 42 214641    tokely@uow.edu.au

Australia, New South Wales
      Child Obesity Research Centre, University of Wollongong, Wollongong,  New South Wales,  2522,  Australia; Recruiting
      University of Newcastle, Newcastle,  New South Wales,  2308,  Australia; Recruiting

Study ID Numbers:  NHMRC Project Grant 354101
Record last reviewed:  April 2005
Last Updated:  April 7, 2005
Record first received:  April 6, 2005
ClinicalTrials.gov Identifier:  NCT00107692
Health Authority: Australia: National Health and Medical Research Council (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-04-08