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

Lide Arenaza, María Medrano, María Amasene, Beatriz Rodríguez-Vigil, Ignacio Díez, Manuel Graña, Ignacio Tobalina, Edurne Maiz, Edurne Arteche, Eider Larrarte, Inge Huybrechts, Catherine Lucy Davis, Jonatan R. Ruiz, Francisco B. Ortega, Javier Margareto, Idoia Labayen

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Article number372
JournalTrials
Volume18
Issue number1
DOIs
StatePublished - Aug 10 2017

Fingerprint

Randomized Controlled Trials
Type 2 Diabetes Mellitus
Exercise
Exosomes
MicroRNAs
Life Style
Blood Cells
Obesity
Accelerometry
Education
Prediabetic State
Photon Absorptiometry
Pandemics
Feeding Behavior
Random Allocation
Body Composition
Insulin Resistance
Comorbidity
Fasting
Hemoglobins

Keywords

  • Children
  • Ectopic fat
  • Exercise
  • Family based lifestyle intervention program
  • MiRNA
  • Type-2 diabetes

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

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. / Arenaza, Lide; Medrano, María; Amasene, María; Rodríguez-Vigil, Beatriz; Díez, Ignacio; Graña, Manuel; Tobalina, Ignacio; Maiz, Edurne; Arteche, Edurne; Larrarte, Eider; Huybrechts, Inge; Davis, Catherine Lucy; Ruiz, Jonatan R.; Ortega, Francisco B.; Margareto, Javier; Labayen, Idoia.

In: Trials, Vol. 18, No. 1, 372, 10.08.2017.

Research output: Contribution to journalArticle

Arenaza, L, Medrano, M, Amasene, M, Rodríguez-Vigil, B, Díez, I, Graña, M, Tobalina, I, Maiz, E, Arteche, E, Larrarte, E, Huybrechts, I, Davis, CL, Ruiz, JR, Ortega, FB, Margareto, J & Labayen, I 2017, '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', Trials, vol. 18, no. 1, 372. https://doi.org/10.1186/s13063-017-2117-y
Arenaza, Lide ; Medrano, María ; Amasene, María ; Rodríguez-Vigil, Beatriz ; Díez, Ignacio ; Graña, Manuel ; Tobalina, Ignacio ; Maiz, Edurne ; Arteche, Edurne ; Larrarte, Eider ; Huybrechts, Inge ; Davis, Catherine Lucy ; Ruiz, Jonatan R. ; Ortega, Francisco B. ; Margareto, Javier ; Labayen, Idoia. / 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. In: Trials. 2017 ; Vol. 18, No. 1.
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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.",
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AU - Amasene, María

AU - Rodríguez-Vigil, Beatriz

AU - Díez, Ignacio

AU - Graña, Manuel

AU - Tobalina, Ignacio

AU - Maiz, Edurne

AU - Arteche, Edurne

AU - Larrarte, Eider

AU - Huybrechts, Inge

AU - Davis, Catherine Lucy

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