Abstract
BackgroundWeight loss improves cardiovascular risk factors and “quality of life”. Most therapeutic approaches fail to induce a sustained weight loss and most individuals undergo weight regain. In this paper the comprehensive design of the “MAINTAIN” study, all assessments as well as the one year lifestyle intervention will be outlined in detail.Methods/Design One-center randomized controlled trial with seven assessment time points conducted 2009-2015. For the randomization eight groups were distinguished in a list to allocate intervention or control group: Females and males either pre-pubertal or pubertal and with a BMI-SDS under or over 2.5. Setting: Weight loss at a residential weight reduction programme Berlin/Brandenburg and intervention at a paediatric outpatient clinic; Participants: 137 children and adolescents (10 to 17 years). Intervention: Participants were randomized after an initial weight loss at a residential weight reduction programme and allocated to intervention (n=65) and control (n=72) conditions. The intervention group received an one-year group multi-professional lifestyle intervention with monthly meetings at the paediatric outpatient obesity clinic. The control group had a free living phase for one year and both groups 48 months follow up. Main outcome measures: Participants who are engaged in monthly intervention meetings will benefit in terms of a sustained weight maintenance. The primary aim is to describe the dynamic of hormonal and metabolic mechanisms counter-balancing sustained weight loss during puberty and adolescence. The secondary aim is to investigate the effect of an intensive family based lifestyle intervention during the weight maintenance period on the endogenous counter-regulation as well as on health related quality of life. The third aim is to establish predictors for successful weight maintenance and risk factors for weight regain in obese children and adolescents.DiscussionWeight maintenance after induced weight loss is one of the most important therapeutic challenges as long as most patients fail to maintain their weight loss. MAINTAIN is the first paediatric RCT addressing in parallel to a RCT in obese adults the course of weight regain after induced weight loss and is embedded in an experimental research consortium in order to also address several molecular mechanisms of weight regain.Trial registrationClinicalTrials NCT00850629, first registration 17 February 2009, verified January 2012, Paediatric part of the interventional study. Ethic proposal approved at 08.04.2009Electronic supplementary materialThe online version of this article (doi:10.1186/s40608-016-0110-8) contains supplementary material, which is available to authorized users.
Highlights
Weight loss improves cardiovascular risk factors and “quality of life”
MAINTAIN is the first paediatric randomized controlled trials (RCT) addressing in parallel to a RCT in obese adults the course of weight regain after induced weight loss and is embedded in an experimental research consortium in order to address several molecular mechanisms of weight regain
Considering a dropout rate of 15 % during intervention and 20 % dropout rate during the initial weight loss period, a total of 150 individuals was determined for the weight reduction period (T-3). To our knowledge this is the first paediatric RCT focused on weight maintenance
Summary
To our knowledge this is the first paediatric RCT focused on weight maintenance (following weight reduction). Success in treating obese children and adolescents is limited by the fast weight regain and it is extremely difficult to achieve weight maintenance even in specialized institutions. This unfortunate situation has been quantified already in meta-analyses [15, 16]. Puberty alone is accompanied by a physiological insulin resistance, especially in girls, shifting the metabolic situation to growth acceleration and anabolism In obese adolescents these conditions are aggravated, resulting in e.g., early menarche in obese girls.
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