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Hormonal regulatory mechanisms in obese children and adolescents after previous weight reduction with a lifestyle intervention: maintain - paediatric part - a RCT from 2009-15.

ABSTRACT: BACKGROUND:Weight 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. DISCUSSION:Weight 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 REGISTRATION:ClinicalTrials NCT00850629, first registration 17 February 2009, verified January 2012, Paediatric part of the interventional study. Ethic proposal approved at 08.04.2009.

SUBMITTER: Bau AM

PROVIDER: S-EPMC4901466 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Hormonal regulatory mechanisms in obese children and adolescents after previous weight reduction with a lifestyle intervention: maintain - paediatric part - a RCT from 2009-15.

Bau Anne-Madeleine AM Ernert Andrea A Krude Heiko H Wiegand Susanna S

BMC obesity 20160610

<h4>Background</h4>Weight 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.<h4>Methods/design</h4>One-center randomized controlled trial with seven assessment time points conducted 2009-2015. For the randomization eight ...[more]

PMID: 27298729

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Project description:Background/objectivesObesity in pregnancy has been associated with increased childhood cardiometabolic risk and reduced life expectancy. The UK UPBEAT multicentre randomised control trial was a lifestyle intervention of diet and physical activity in pregnant women with obesity. We hypothesised that the 3-year-old children of women with obesity would have heightened cardiovascular risk compared to children of normal BMI women, and that the UPBEAT intervention would mitigate this risk.Subjects/methodsChildren were recruited from one UPBEAT trial centre. Cardiovascular measures included blood pressure, echocardiographic assessment of cardiac function and dimensions, carotid intima-media thickness and heart rate variability (HRV) by electrocardiogram.ResultsCompared to offspring of normal BMI women (n = 51), children of women with obesity from the trial standard care arm (n = 39) had evidence of cardiac remodelling including increased interventricular septum (IVS; mean difference 0.04 cm; 95% CI: 0.018 to 0.067), posterior wall (PW; 0.03 cm; 0.006 to 0.062) and relative wall thicknesses (RWT; 0.03 cm; 0.01 to 0.05) following adjustment. Randomisation of women with obesity to the intervention arm (n = 31) prevented this cardiac remodelling (intervention effect; mean difference IVS -0.03 cm (-0.05 to -0.008); PW -0.03 cm (-0.05 to -0.01); RWT -0.02 cm (-0.04 to -0.005)). Children of women with obesity (standard care arm) compared to women of normal BMI also had elevated minimum heart rate (7 bpm; 1.41 to 13.34) evidence of early diastolic dysfunction (e prime) and increased sympathetic nerve activity index by HRV analysis.ConclusionsMaternal obesity was associated with left ventricular concentric remodelling in 3-year-old offspring. Absence of remodelling following the maternal intervention infers in utero origins of cardiac remodelling.Clinical trial registry name and registration numberThe UPBEAT trial is registered with Current Controlled Trials, ISRCTN89971375.

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Hormonal regulatory mechanisms in obese children and adolescents after previous weight reduction with a lifestyle intervention: maintain - paediatric part - a RCT from 2009-15.

Publications

Hormonal regulatory mechanisms in obese children and adolescents after previous weight reduction with a lifestyle intervention: maintain - paediatric part - a RCT from 2009-15.

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