Outcomes and costs of primary care surveillance and intervention for overweight or obese children: The LEAP 2 randomised controlled trial
Wake, Melissa, Baur, Louise A., Gerner, Bibi, Gibbons, Kay, Gold, Lisa, Gunn, Jane, Levickis, Penny, McCallum, Zoe, Naughton, Geraldine, Sanci, Lena and Ukoumunne, Obioha C.. (2009) Outcomes and costs of primary care surveillance and intervention for overweight or obese children: The LEAP 2 randomised controlled trial. British Medical Journal. 339(7730), pp. 1 - 8. https://doi.org/10.1136/bmj.b3308
|Authors||Wake, Melissa, Baur, Louise A., Gerner, Bibi, Gibbons, Kay, Gold, Lisa, Gunn, Jane, Levickis, Penny, McCallum, Zoe, Naughton, Geraldine, Sanci, Lena and Ukoumunne, Obioha C.|
Objective: To determine whether ascertainment of childhood obesity by surveillance followed by structured secondary prevention in primary care improved outcomes in overweight or mildly obese children.
Design: Randomised controlled trial nested within a baseline cross sectional survey of body mass index (BMI). Randomisation and outcomes measurement, but not participants, were blinded to group assignment.
Setting: 45 family practices (66 general practitioners) in Melbourne, Australia.
Participants: 3958 children visiting their general practitioner in May 2005-July 2006 were surveyed for BMI. Of these, 258 children aged 5 years 0 months up to their 10th birthday who were overweight or obese by International Obesity Taskforce criteria were randomised to intervention (n=139) or control (n=119) groups. Children who were very obese (UK BMI z score ≥3.0) were excluded.
Intervention: Four standard consultations over 12 weeks targeting change in nutrition, physical activity, and sedentary behaviour, supported by purpose designed family materials.
Main outcomes measures: Primary measure was BMI at 6 and 12 months after randomisation. Secondary measures were mean activity count/min by 7-day accelerometry, nutrition score from 4-day abbreviated food frequency diary, and child health related quality of life. Differences were adjusted for socioeconomic status, age, sex, and baseline BMI.
Results: Of 781 eligible children, 258 (33%) entered the trial; attrition was 3.1% at 6 months and 6.2% at 12 months. Adjusted mean differences (intervention − control) at 6 and 12 months were, for BMI, −0.12 (95% CI −0.40 to 0.15, P=0.4) and −0.11 (−0.45 to 0.22, P=0.5); for physical activity in counts/min, 24 (−4 to 52, P=0.09) and 11 (−26 to 49, P=0.6); and, for nutrition score, 0.2 (−0.03 to 0.4, P=0.1) and 0.1 (−0.1 to 0.4, P=0.2). There was no evidence of harm to the child. Costs to the healthcare system were significantly higher in the intervention arm.
Conclusions: Primary care screening followed by brief counselling did not improve BMI, physical activity, or nutrition in overweight or mildly obese 5-10 year olds, and it would be very costly if universally implemented. These findings are at odds with national policies in countries including the US, UK, and Australia.
Trial registration: ISRCTN 52511065 (www.isrctn.org)
|Journal||British Medical Journal|
|Journal citation||339 (7730), pp. 1 - 8|
|Publisher||BMJ Publishing Group ltd.|
|Digital Object Identifier (DOI)||https://doi.org/10.1136/bmj.b3308|
|Open access||Open access|
|Page range||1 - 8|
|Place of publication||United Kingdom|
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