Prevention of Diabetes in Overweight/Obese Preadolescent Children
Condition: Overweight Children With Type 2 Diabetes Risk
MeSH terms: Diabetes Mellitus; Overweight
Study type: Interventional

Summary: 
      Background: The global pandemic obesity has led to increased risk for prediabetes and type 2
      diabetes (T2D).

      Objectives: (i) To evaluate the effect of a 22 weeks multidisciplinary intervention program
      including exercise on T2D risk in pre-adolescents with high risk to develop T2D, and (ii) To
      identify the profile of microRNA in circulating exosomes and in blood peripheral mononuclear
      cells in pre-adolescents with high risk to develop T2D and its response to a
      multidisciplinary intervention program including exercise.
    

Detailed description: 
      Background: The global pandemic obesity has led to increased risk for prediabetes and type 2
      diabetes (T2D).

      Objectives: (i) To evaluate the effect of a 22 weeks multidisciplinary intervention program
      including exercise on T2D risk in pre-adolescents with high risk to develop T2D, and (ii) To
      identify the profile of microRNA in circulating exosomes and in blood peripheral mononuclear
      cells in pre-adolescents with high risk to develop T2D and its response to a
      multidisciplinary intervention program including exercise.

      Design, participants and methods: A total of 84 children with high risk of type 2 diabetes
      mellitus aged 8-12 years 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). The duration of training sessions will be 90 min of exercise, 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; total and abdominal fat (dual X-ray absorptiometry);
      pancreatic, hepatic and visceral fat (magnetic resonance imaging); systolic and diastolic
      blood pressure; fasting leptin, adiponectin, fibroblast growth factor-21, fetuin-A,
      hs-C-reactive protein, tumor necrosis factor-alfa, interleukin (IL)-1beta and IL-6 and lipid
      profile; carotid intima-media thickness (ultrasonography), microRNA expression in circulating
      exosomes and in blood peripheral mononuclear cells (MiSeq-Illumina); functional peak aerobic
      capacity (cardiopulmonary exercise testing and 20m shuttle run test). Changes in dietary
      habits (food frequency questionnaire and two non-consecutive 24h recalls), physical activity
      and sleep (accelerometry); sex, age, socioeconomic status and pubertal status will be used as
      potential confounders.

      Discussion/Conclusions: Early prevention and identification of children with high risk to
      develop T2D could help to reduce the morbidity and mortality associated with the disease.
    

Intervention name(s): lifestyle and psycho-educational program; Exercise plus lifestyle and psycho-educational program
Intervention type(s): Behavioral; Other
Intervention description(s): The family-based healthy lifestyle education and psychological education program will be followed once every two weeks (11 sessions over 22 weeks) for 90 minutes (45 minutes in the healthy lifestyle education program and 45 minutes in the psycho-educational intervention). The sessions of the healthy lifestyle education and psycho-educational interventions will be developed simultaneously and delivered to both parents (or caregivers) and children, separately. The family-based healthy lifestyle education program will be conducted by experienced nutritionists and the psycho-educational program by experienced psychologists in behavior changes; The intervention group will attend the same lifestyle education and psycho-educational program plus the exercise program. The exercise group will do exercise 3 days/week, 90 minutes per session, over a 22-week period. The program will be offered to the families five days per week to choose a total of three days/week. Sessions will be designed and supervised by exercise specialists. The duration of training sessions will be 90 minutes of exercise, including warm-up, moderate to vigorous aerobic activities, and strength exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment