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Trials. 2017 Aug 10;18(1):372. doi: 10.1186/s13063-017-2117-y.

Prevention of diabetes in overweight/obese children through a family based intervention program including supervised exercise (PREDIKID project): study protocol for a randomized controlled trial.

Author information

1
Nutrition, Exercise and Health Research group, Elikadura, Ariketa Fisikoa eta Osasuna, ELIKOS group, Department of Nutrition and Food Science, University of the Basque Country, UPV/EHU, Vitoria-Gasteiz, Spain.
2
Department of Magnetic Resonance Imaging, Osatek, University Hospital of Alava (HUA), Vitoria-Gasteiz, Spain.
3
Paediatric Endocrinology Unit, University Hospital of Araba (HUA), Vitoria-Gasteiz, Spain.
4
Computational Intelligence Group, University of the Basque Country, UPV/EHU, Donostia, Spain.
5
Department of Nuclear Medicine, University Hospital of Araba (HUA), Vitoria-Gasteiz, Spain.
6
Department of Personality, Assessment and Psychological Treatment, University of the Basque Country, UPV/EHU, San Sebastián-Donostia, Spain.
7
Department of Radiology, University Hospital of Araba (HUA), Vitoria-Gasteiz, Spain.
8
Technological Services Division, Health and quality of life, TECNALIA, Miñano, Spain.
9
Nutrition and Metabolism Section, International Agency for Research on Cancer, World Health Organization, Lyon, France.
10
Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, GA, USA.
11
PROmoting FITness and Health through physical activity research group (PROFITH), Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Grenada, Spain.
12
Department of Health Sciences, Public University of Navarra, Pamplona, Spain. idoia.labayen@unavarra.es.

Abstract

BACKGROUND:

The global pandemic of obesity has led to an increased risk for prediabetes and type-2 diabetes (T2D). The aims of the current project are: (1) to evaluate the effect of a 22-week family based intervention program, including supervised exercise, on insulin resistance syndrome (IRS) risk in children with a high risk of developing T2D and (2) to identify the profile of microRNA in circulating exosomes and in peripheral blood mononuclear cells in children with a high risk of developing T2D and its response to a multidisciplinary intervention program including exercise.

METHODS:

A total of 84 children, aged 8-12 years, with a high risk of T2D will be included and randomly assigned to control (N = 42) or intervention (N = 42) groups. The control group will receive a family based lifestyle education and psycho-educational program (2 days/month), while the intervention group will attend the same lifestyle education and psycho-educational program plus the exercise program (3 days/week, 90 min per session including warm-up, moderate to vigorous aerobic activities, and strength exercises). The following measurements will be evaluated at baseline prior to randomization and after the intervention: fasting insulin, glucose and hemoglobin A1c; body composition (dual-energy X-ray absorptiometry); ectopic fat (magnetic resonance imaging); microRNA expression in circulating exosomes and in peripheral blood mononuclear cells (MiSeq; Illumina); cardiorespiratory fitness (cardiopulmonary exercise testing); dietary habits and physical activity (accelerometry).

DISCUSSION:

Prevention and identification of children with a high risk of developing T2D could help to improve their cardiovascular health and to reduce the comorbidities associated with obesity.

TRIAL REGISTRATION:

ClinicalTrials.gov, ID: NCT03027726 . Registered on 16 January 2017.

KEYWORDS:

Children; Ectopic fat; Exercise; Family based lifestyle intervention program; Type-2 diabetes; miRNA

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