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Trial registered on ANZCTR


Registration number
ACTRN12608000055303
Ethics application status
Not yet submitted
Date submitted
22/01/2008
Date registered
29/01/2008
Date last updated
29/01/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Better outcomes for obese children in general practice: randomized controlled trial of a new shared-care model vs usual care
Scientific title
Better outcomes for obese children in general practice: randomized controlled trial of a new shared-care model vs usual care
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood obesity 2748 0
Condition category
Condition code
Public Health 2871 2871 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each child will attend a single initial multidisciplinary obesity clinic at Melbournes Royal Childrens Hospital, accompanied by parent(s)/guardian(s), where they will see a team comprising a paediatrician, a paediatric dietitian and an exercise specialist. A medical and family history will be taken and assessments of daily diet, physical activity (both background and formal exercise) and sedentary activities will be recorded. Clinical examination will be undertaken to identify and quantify secondary problems of obesity, with appropriate investigations (eg liver function tests, glucose tolerance) as clinically indicated. The team will then discuss lifestyle changes that may assist weight management in the child, encouraging changes in family behaviour wherever possible. This is in accordance with research showing beneficial results to the child when the parents are involved and is consistent with the National Health and Medical Research Council (NHMRC) recommendation that weight maintenance, rather than actual weight loss, should be encouraged in this age range. The paediatric dietitian will outline general principles of healthy eating and offer targeted advice based on the child and family eating patterns and the health and exercise specialist will advise on forms of enjoyable physical activity. Depending on the first years development work, this process could be expedited and enhanced by offering some of this information in intake sessions allowing group education and demonstration.

Details of the consultation including the initial plan and individualized resources provided will be entered into the shared-care software, which will be set up so that every childs progress will be accessible by both the childs GP and the obesity team throughout the 12 months of the intervention. Each child will then be offered appointments with their general practitioner at 6 weeks and at 3, 6, 9 and 12 months, during which lifestyle and Body Mass Index (BMI) progress will be reviewed; problems identified and solved where possible; new goals set using brief solution-focused techniques, software decision support and printable educational material; and results recorded in the database. At 6 month, the obesity clinician coordinator and GP will together formally review each childs progress using the synchronised software, with a focus on solutions and guidance, and the clinician will be available to the GP on as as-needed basis throughout the year.
Intervention code [1] 2484 0
Behaviour
Intervention code [2] 2485 0
Lifestyle
Comparator / control treatment
The usual care (control) arm will not be offered an obesity clinic appointment or identified as being in the trial to their GP (this approach was acceptable to GPs, ethics committees and worked well in Live Eat And Play (LEAP) trials). Parents will be informed that they are free to seek assistance with their GP or with any other service, and given a written list of potential local sources of assistance. Should they present to their GP, the GP will be able to implement their usual clinical care and utilize skills gained in the training process, but will not be able to access the shared-care, software program, tracking or educational materials, or obesity team support. An audit of all control childrens medical records in our LEAP trial indicated that no overweight or obese control children in fact consulted their GP for weight management in the 12 months following recruitment, suggesting that contamination in this trial will also be low and justifying our decision to randomize at the level of the individual rather than the GP or the practice.
Control group
Active

Outcomes
Primary outcome [1] 3757 0
Compared to the control group, the intervention children will demonstrate a reduced relative BMI, measured as a z-score
Timepoint [1] 3757 0
At 12 months after randomisation
Secondary outcome [1] 6343 0
Compared to the control group, the intervention children will demonstrate a reduced % fat and increased % lean muscle mass
Timepoint [1] 6343 0
At 12 months after randomisation
Secondary outcome [2] 6344 0
Compared to the control group, the intervention children will demonstrate a reduced waist circumference
Timepoint [2] 6344 0
At 12 months after randomisation
Secondary outcome [3] 6345 0
Compared to the control group, the intervention children will not show evidence of harm (ie poorer health status, body satisfaction, or global self-worth)
Timepoint [3] 6345 0
At 12 months after randomisation
Secondary outcome [4] 6346 0
The intervention will be acceptable and feasible to (i) parents; (ii) general practitioners; (iii) general practice staff; and (iv) the specialist obesity team.
Timepoint [4] 6346 0
Throughout the duration of the study (3 years)

Eligibility
Key inclusion criteria
All eligible obese (according to International Obesity Taskforce (IOTF) BMI cut-off points) 3-9 year olds identified via participating general practitioners, for whom parents provide informed consent.
Minimum age
3 Years
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children will be excluded if they
(1) are receiving ongoing weight management in a secondary or tertiary care program;
(2) have a known endocrine or chromosomal cause for their overweight; or
(3) have major disabilities or health conditions precluding their participation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The trial will be publicised within each GP practice by poster, brochure and practice staff. Trained practice staff will opportunistically offer to weigh/measure children attending for consultations, using accurate digital scales and rigid stadiometers supplied by the research team, and mail or fax their details to the research team. Practices will also invite by mail all of their in-age children to attend one of up to two dedicated weigh-measure sessions run by the research team in the surgery.

Families will be allocated to treatment group by a staff member not otherwise involved in the project. Randomisation will be via a concealed, computerised random number sequence stratified by general practitioner and pre-generated by the Clinical Epidemiology and Biostatistics Unit at the Royal Childrens Hospital. Researchers conducting follow up visits remained blinded throughout data collection. Intervention status will be recorded in a password-protected database concealed to all staff involved in follow up data collection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
At the end of Year 1, children will be randomized simultaneously to allow for smooth scheduling of shared-care appointments and a more concentrated delivery of intervention children to the general practitioners. Randomisation will be via a concealed, computerised random number sequence stratified by general practitioner and pre-generated by the Clinical Epidemiology and Biostatistics Unit at the Royal Childrens Hospital.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3013 0
Government body
Name [1] 3013 0
National Health and Medical Research Council
Country [1] 3013 0
Australia
Primary sponsor type
Hospital
Name
Royal Childrens Hospital
Address
Royal Childrens Hospital
Flemington Road
Parkville
Victoria, 3052
Country
Australia
Secondary sponsor category [1] 2716 0
Other
Name [1] 2716 0
Centre for Community Child Health at the Murdoch Childrens Research Institute, Royal Children?s Hospital
Address [1] 2716 0
Flemington Road,
Parkville,
Victoria 3052
Country [1] 2716 0
Australia
Secondary sponsor category [2] 2717 0
Individual
Name [2] 2717 0
Associate Professor Melissa Wake
Address [2] 2717 0
Centre for Community Child Health,
The Royal Children's Hospital,
Flemington Road,
Parkville,
Victoria 3052
Country [2] 2717 0
Australia
Other collaborator category [1] 169 0
University
Name [1] 169 0
University of Melbourne
Address [1] 169 0
200 Berkeley Street
Carlton
Victoria, 3053
Country [1] 169 0
Australia
Other collaborator category [2] 170 0
University
Name [2] 170 0
The University of Adelaide
Address [2] 170 0
Royal Adelaide Hospital,
North Terrace,
Adelaide,
South Australia, 5000
Country [2] 170 0
Australia
Other collaborator category [3] 171 0
University
Name [3] 171 0
Deakin University
Address [3] 171 0
221 Burwood Highway
Burwood
Victoria, 3125
Country [3] 171 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4959 0
Royal Childresn Hospital Human Research Ethics Committee
Ethics committee address [1] 4959 0
Flemington Road,
Parkville,
Victoria 3052
Ethics committee country [1] 4959 0
Australia
Date submitted for ethics approval [1] 4959 0
21/01/2008
Approval date [1] 4959 0
Ethics approval number [1] 4959 0
28017

Summary
Brief summary
Few management options are available to the 200,000 Australian children with established obesity. Paradoxically, whereas speciality obesity clinics improve body mass index (BMI) but are accessible to very few obese children, general practice is universally available - but so far frustratingly ineffectual.
We aim to trial an innovative shared-care approach to the management of childhood obesity, drawing together four established lines of research: (i) specialist child obesity approaches that are known to be effective; (ii) positive aspects of our previous child obesity prevention general practice trials; (iii) computerised support and decision assistance in primary care; and (iv) the effectiveness of shared-care approaches. Because all elements are already in place, it has a high degree of feasibility and, we believe, a high chance of success.
This trial addresses the urgent need identified in the 2003 NHMRC Clinical Practice Guidelines for the Management of Overweight and Obesity in Children and Adolescents for ‘simple, well-designed intervention studies which can be translated into usual clinical practice’. In the first year, the software support and clinical approaches will be customized and focus-tested. The trial itself will involve approximately 45 general practitioners and 172 obese children aged 3-9 years and their families in the second and third years. Half the children will attend a specialist multidisciplinary obesity session, followed by supported general practice care for 12 months. The other half will be offered usual care. After 12 months, we aim for reductions in BMI, percentage body fat, and waist girth in the shared care compared to the usual care group. We will also conduct an economic evaluation, to understand the costs of the new model, compared with usual care, to government and families against all outcomes at 12 months.
If effective, benefits would include increased general practitioner identification of childhood obesity; a shift in focus towards younger obese children (for whom treatment is more effective and secondary prevention of morbidity is still possible); and a replicable, feasible, cost-effective primary care approach to childhood overweight/obesity tailored to the Australian health care system.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28318 0
Address 28318 0
Country 28318 0
Phone 28318 0
Fax 28318 0
Email 28318 0
Contact person for public queries
Name 11475 0
Associate Professor Melissa Wake
Address 11475 0
Royal Childrens Hospital
Flemington Road
Parkville
Victoria, 3052
Australia
Country 11475 0
Australia
Phone 11475 0
03 9345 5937
Fax 11475 0
03 9345 5900
Email 11475 0
[email protected]
Contact person for scientific queries
Name 2403 0
Associate Professor Melissa Wake
Address 2403 0
Royal Childrens Hospital
Flemington Road
Parkville
Victoria, 3052
Australia
Country 2403 0
Australia
Phone 2403 0
03 9345 5937
Fax 2403 0
03 9345 5900
Email 2403 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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