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Better outcomes for obese children in general practice: randomized controlled trial of a new shared-care model vs usual care

Better outcomes for obese children in general practice: randomized controlled trial of a new shared-care model vs usual care

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000055303
Enrollment
180
Registered
2008-01-29
Start date
2009-04-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 sec

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.

Sponsors

Royal Childrens Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
3 Years to 9 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 26, 2026