Effect of Mindfulness on Stress, Appetite Hormones and Body Weight of Obese Schoolchildren. Controlled Clinical Trial
Condition: Obesity, Childhood; Mindfulness
MeSH terms: Pediatric Obesity; Body Weight
Study type: Interventional

Summary: 
      In addition to diet and sedentary lifestyle, factors such as stress, depression and anxiety
      have been found associated in up to 86% of cases of obesity in children. Mindfulness is a
      method based on the concentration of attention, awareness and meditation, which has been
      successfully used to reduce stress, depression and anxiety in individuals with some pathology
      in the short term (eight weeks).

      Objective: To determine if an intervention with mindfulness is effective to reduce the
      stress, appetite, and body weight of a group of school children with obesity and stress
      comparing them with a group that receives conventional therapy.

      Methods For a controlled clinical trial, 60 children of 10-14 years of age with obesity (BMI>
      2 SD) and stress (Spence scale> 60) will be selected, and randomly assigned to a group that
      receives the intervention with mindfulness (M8S), or to the control group (TC);The
      intervention with Mindfulness will be done once a week for 8 weeks. Measurements of BMI,
      glucose, leptin, ghrelin, cortisol and insulin will be carried out at the beginning of the
      study, and repeated at the end of the intervention and eight weeks after finishing the
      intervention to evaluate relapses.
    

Detailed description: 
      Parents of children 10-14 years of age with suspected obesity will be invited to participate.
      When the child and at least one of the parents wish to participate, anthropometry will be
      performed to calculate the BMI z-score and the Spence questionnaire will be applied to
      identify stress. If they meet the selection criteria, they will be recorded in a
      pre-registration form to call them once the sample size is completed in order to start the
      interventions simultaneously for all the children and in parallel for the two groups.

      To initiate the intervention, the children will be summoned in the Research Unit accompanied
      by at least one of the parents at 7:00 with at least eight hours of fasting, without brushing
      their teeth and without having performed any physical activity, for explain what their
      participation in the study consists of and ask them to sign the letters of consent and
      informed consent. Anthropometric measurements (weight, height, waist circumference) will be
      taken, and a peripheral blood sample will be taken to determine the concentrations of
      insulin, glucose, leptin and ghrelin, and a 24-h reminder questionnaire will be applied. When
      they leave, they will be given a kit for collecting saliva samples to calculate the Cortisol
      Awakening Response and will be given the appropriate instructions.

      Once all the children's anthropometric and diet information has been obtained, they will be
      randomly assigned to one of the two groups using a computerized random number table. The
      children assigned to the mindfulness group will be summoned every Wednesday in the classroom
      of the Research Unit to receive the sessions, which will be taught by an expert in
      mindfulness techniques in children of the Spanish School of Transpersonal Development.
      Children assigned to the conventional treatment group will be summoned every Thursday at the
      same place to receive reinforcement talks aimed at motivating the child and their parents to
      adhere to the indications of diet and physical activity, taught by a pediatric
      endocrinologist with nutrition training. involved in the investigation.

      Body weight will be measured every week before the session, and biochemical measurements will
      be repeated at the end of the eight weeks of intervention and eight weeks after the end of
      the intervention to assess relapses.
    

Intervention name(s): Mindfulness
Intervention type(s): Behavioral
Intervention description(s): Mindfulness is a method based on the concentration of attention, awareness and meditation, which has been used successfully to reduce stress, depression and anxiety in individuals with some pathology in the short term
Other intervention name(s): method on the concentration of attention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment