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
  Purpose

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 Intervention
Obesity
Behavioral: Physical activity and diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of a Weight Management Program for Overweight and Obese Children: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Wollongong:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 216
Study Start Date: March 2005
Estimated Study Completion Date: October 2007
  Hide Detailed Description

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   66 Months to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107692

Locations
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
Sponsors and Collaborators
University of Wollongong
Newcastle University
University of Sydney
Illawarra Area Health Services
Investigators
Principal Investigator: Tony D Okely, PhD, BEd University of Wollongong
  More Information

No publications provided by University of Wollongong

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00107692     History of Changes
Other Study ID Numbers: NHMRC Project Grant 354101
Study First Received: April 6, 2005
Last Updated: September 11, 2006
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by University of Wollongong:
Child Obesity
Physical activity
community intervention study
competence
diet and nutrition
Nutrition
physical activity

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014