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Outcome data from the LEAP (Live, Eat and Play) trial: a randomized controlled trial of a primary care intervention for childhood overweight/mild obesity

Abstract

Objectives:

To reduce gain in body mass index (BMI) in overweight/mildly obese children in the primary care setting.

Design:

Randomized controlled trial (RCT) nested within a baseline cross-sectional BMI survey.

Setting:

Twenty nine general practices, Melbourne, Australia.

Participants:

(1) BMI survey: 2112 children visiting their general practitioner (GP) April–December 2002; (2) RCT: individually randomized overweight/mildly obese (BMI z-score <3.0) children aged 5 years 0 months–9 years 11 months (82 intervention, 81 control).

Intervention:

Four standard GP consultations over 12 weeks, targeting change in nutrition, physical activity and sedentary behaviour, supported by purpose-designed family materials.

Main outcome measures:

Primary: BMI at 9 and 15 months post-randomization. Secondary: Parent-reported child nutrition, physical activity and health status; child-reported health status, body satisfaction and appearance/self-worth.

Results:

Attrition was 10%. The adjusted mean difference (intervention–control) in BMI was −0.2 kg/m2 (95% CI: −0.6 to 0.1; P=0.25) at 9 months and −0.0 kg/m2 (95% CI: −0.5 to 0.5; P=1.00) at 15 months. There was a relative improvement in nutrition scores in the intervention arm at both 9 and 15 months. There was weak evidence of an increase in daily physical activity in the intervention arm. Health status and body image were similar in the trial arms.

Conclusions:

This intervention did not result in a sustained BMI reduction, despite the improvement in parent-reported nutrition. Brief individualized solution-focused approaches may not be an effective approach to childhood overweight. Alternatively, this intervention may not have been intensive enough or the GP training may have been insufficient; however, increasing either would have significant cost and resource implications at a population level.

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Acknowledgements

Contributors: The project was initiated and funding obtained by MW, ZM, JG, LB, KG and EW. All authors contributed to developing the protocols and reviewing, editing and approving the final version of the paper. The trial was implemented by ZM and MW who oversaw all stages. ZM, BG and JS carried out recruitment and data collection; ZM, BG and OU conducted the analyses with the exception of the economic analysis which was performed by LG. ZM and MW wrote the paper. ZM is the guarantor and accepts full responsibility for the conduct of the study, had access to the data, and controlled the decision to publish. Sharon Foster, Helen Cahill and Denise Findlay contributed medical education expertise and Christy Collins assisted in early recruitment of families.

Ethical approval: The project was approved by the Royal Children's Hospital Ethics in Human Research Committee (EHRC 2109).

Funding: ZM was funded via Public Health Postgraduate National Health and Medical Research Council Scholarship (ID 216745). The LEAP trial was funded via a grant from the Australian Health Ministers' Advisory Council for Priority Driven Research (AHMAC PDR 2001/15).

Statement of competing interests: This study was funded by an Australian Health Ministers' Advisory Council Priority Driven Research Project Grant (AHMAC PDR 2001/15). The supporting source had neither involvement in the design and conduct of the study nor control or influence over the writing and submission of this manuscript. There is no conflict of interest.

Sources of support: Australian Health Ministers' Advisory Council Strategic Research Fund; National Health and Medical Research Council Public Health Postgraduate Scholarship.

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McCallum, Z., Wake, M., Gerner, B. et al. Outcome data from the LEAP (Live, Eat and Play) trial: a randomized controlled trial of a primary care intervention for childhood overweight/mild obesity. Int J Obes 31, 630–636 (2007). https://doi.org/10.1038/sj.ijo.0803509

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