Study protocol

Go4it; study design of a randomised controlled trial and economic evaluation of a multidisciplinary group intervention for obese adolescents for prevention of diabetes mellitus type 2

Geesje H Hofsteenge^1*, Marijke JM Chinapaw^2,3, Peter JM Weijs¹, Maurits W van Tulder^2,4 and Henriette A Delemarre-van de Waal⁵

• * Corresponding author: Geesje H Hofsteenge A.Hofsteenge@vumc.nl

Author Affiliations

¹ Dept. of Nutrition & Dietetics, VU University Medical Center, Amsterdam, The Netherlands

² EMGO Institute, VU University Medical Center, Amsterdam, The Netherlands

³ Dept. of Public and Occupational Health, VU University Medical Center, Amsterdam, The Netherlands

⁴ Dept. of Health Sciences, Faculty of Earth and Life Sciences, VU University, Amsterdam, The Netherlands

⁵ Dept. of Paediatrics, VU University Medical Center, Amsterdam, The Netherlands

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BMC Public Health 2008, 8:410 doi:10.1186/1471-2458-8-410

Published: 16 December 2008

Abstract

Background

In the Netherlands, the first adolescents with diabetes mellitus type 2 as a result of obesity have recently been diagnosed. Therefore, it is very important that programs aiming at the prevention of type 2 diabetes of obese adolescents are developed and evaluated.

Methods

Go4it is a multidisciplinary group treatment that focuses on: 1) increasing awareness of the current dietary and physical activity behaviour (i.e. energy balance behaviour), 2) improving diet, 3) decreasing sedentary behaviour, 4) increasing levels of physical activity, and 5) coping with difficult situations. Go4it consists of 7 sessions with an interval of 2–3 weeks.

The effectiveness of the multidisciplinary group treatment compared with usual care (i.e. referral to a dietician) was evaluated in a randomised controlled trial. We examined effects on BMI(sds), body composition, energy expenditure, glucose tolerance and insulin resistance (primary outcome measure), as well as dietary and physical activity behaviour and quality of life. An economic evaluation from a societal perspective was conducted alongside the randomised trial to evaluate the cost-effectiveness of the multidisciplinary treatment program vs. usual care.

Discussion

In this paper we described a multidisciplinary treatment program (Go4it) for obese adolescents and the design of a randomised controlled trial and economic evaluation to evaluate its effectiveness and cost-effectiveness.

Trial registration

Netherlands Trial Register (ISRCTN27626398).