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ObesityNCT00107692

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

A study testing Physical activity and diet in people with Obesity, run by University of Wollongong at 2 sites in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 66 months to 9 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Physical activity and diet
How many people
216 participants
Where
2 sitesAustralia
Study dates
Mar 2005to Oct 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 66 months to 9 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • Children with BMI outside the specified range
  • Children on medication that may influence obesity
  • Children that have conditions that may influence obesity

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

  • University of Newcastle

    Newcastle, New South Wales, 2308

  • Child Obesity Research Centre, University of Wollongong

    Wollongong, New South Wales, 2522

Other trials in Australia

About this study

Official title: 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.

Read the 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.

Conditions
Obesity
Being tested
Physical activity and diet
Keywords
Child Obesity, Physical activity, community intervention study, competence, diet and nutrition, Nutrition
Medical subject headings
Obesity, Pediatric Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical activity and dietBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate and compare in overweight children the effectiveness of the following interventions: a parent-centered dietary modification program

  2. a physical activity skill development program

  3. and a parent-centered dietary modification + physical activity skill development program.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2005 (estimated)
  2. Study startMar 2005
  3. Study completionOct 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
216 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00107692
Sponsor's protocol ID
NHMRC Project Grant 354101
Status last verified
Sep 2006
First submitted
6 Apr 2005
Last updated
13 Sep 2006
Results posted
No

Publications

  • Burrows T, Janet WM, Collins CE. Long-term changes in food consumption trends in overweight children in the HIKCUPS intervention. J Pediatr Gastroenterol Nutr. 2011 Nov;53(5):543-7. doi: 10.1097/MPG.0b013e3182274829.

    PubMed 21670711

  • Collins CE, Okely AD, Morgan PJ, Jones RA, Burrows TL, Cliff DP, Colyvas K, Warren JM, Steele JR, Baur LA. Parent diet modification, child activity, or both in obese children: an RCT. Pediatrics. 2011 Apr;127(4):619-27. doi: 10.1542/peds.2010-1518. Epub 2011 Mar 28.

    PubMed 21444600

  • Burrows T, Collins CE, Garg ML. Omega-3 index, obesity and insulin resistance in children. Int J Pediatr Obes. 2011 Jun;6(2-2):e532-9. doi: 10.3109/17477166.2010.549489. Epub 2011 Jan 12.

    PubMed 21226540

  • Cliff DP, Okely AD, Morgan PJ, Steele JR, Jones RA, Colyvas K, Baur LA. Movement skills and physical activity in obese children: randomized controlled trial. Med Sci Sports Exerc. 2011 Jan;43(1):90-100. doi: 10.1249/MSS.0b013e3181e741e8.

    PubMed 20473216

  • Okely AD, Collins CE, Morgan PJ, Jones RA, Warren JM, Cliff DP, Burrows TL, Colyvas K, Steele JR, Baur LA. Multi-site randomized controlled trial of a child-centered physical activity program, a parent-centered dietary-modification program, or both in overweight children: the HIKCUPS study. J Pediatr. 2010 Sep;157(3):388-94, 394.e1. doi: 10.1016/j.jpeds.2010.03.028. Epub 2010 May 6.

    PubMed 20447648

  • Burrows T, Warren JM, Collins CE. The impact of a child obesity treatment intervention on parent child-feeding practices. Int J Pediatr Obes. 2010;5(1):43-50. doi: 10.3109/17477160902957158.

    PubMed 19437180

  • Jones RA, Warren JM, Okely AD, Collins CE, Morgan PJ, Cliff DP, Burrows T, Cleary J, Baur LA. Process evaluation of the Hunter Illawarra Kids Challenge Using Parent Support study: a multisite randomized controlled trial for the management of child obesity. Health Promot Pract. 2010 Nov;11(6):917-27. doi: 10.1177/1524839908328994. Epub 2009 Jan 21.

    PubMed 19158237

  • Burrows TL, Warren JM, Colyvas K, Garg ML, Collins CE. Validation of overweight children's fruit and vegetable intake using plasma carotenoids. Obesity (Silver Spring). 2009 Jan;17(1):162-8. doi: 10.1038/oby.2008.495. Epub 2008 Nov 6.

    PubMed 18997681

Questions about this trial

What is this clinical trial studying?

A study testing Physical activity and diet in people with Obesity, run by University of Wollongong at 2 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate and compare in overweight children the effectiveness of the following interventions: a parent-centered dietary modification program. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00107692, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2006.

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