Obesity Clinical Trial
Official title:
Evaluation of Family Intervention Program for the Treatment of Overweight or Obese Children (Nereu Program): Randomized Clinical Trial
Objectives: To evaluate the effectiveness of the Nereu program compared to standard care
(advice on increased physical activity and nutrition) such as a health intervention tool for
the childhood obesity management
Methods/Design: The study design is a randomized controlled multicenter clinical trial using
two types of treatment. Population and sample: Children 6 to 12 years with overweight or
obesity, according to the z score of body mass index (BMI z) >= 1 for age and gender defined
by International Obesity Task Force (IOTF). It is considered necessary to recruit 100
children: 50 control group (CG) and 50 Intervention (IG). Study Intervention: Nereu Group: 8
month intervention with 3 weekly training sessions doing physical exercise for children and
a weekly session for parents of physical activity and healthy eating habits and behaviour
strategies, that involves both parental and child participation. The control group will
receive a monthly session of healthy physical and eating habits. Main Outcome Measures:
Improvement of BMI z, physical activity and nutrition habits, behaviour components and
quality life related to health at the end, 6 and 12 months after intervention.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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