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Effect of Mindfulness on Stress, Appetite Hormones and Body Weight of Obese Schoolchildren. Controlled Clinical Trial (Mindfulness)

Primary Purpose

Obesity, Childhood, Mindfulness

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Mindfulness
Sponsored by
Coordinación de Investigación en Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Childhood

Eligibility Criteria

10 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

obesity (BMI> 2 SD) and stress (Spence scale> 60) -

Exclusion Criteria:

  • taking any antihyperglycemic medication
  • obesity of endocrinological origin
  • do not wish to participate

Sites / Locations

  • Mardia Lopez Alarcon
  • Unit or research in Medical Nutrition, Pediatric Hospital CMN "Siglo XXI", Instituto Mexicano del Seguro Social

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mindfulness

Control

Arm Description

In this group, children and their parents will receive a mindfulness session once a week, with a duration of 90 minutes, during 8 weeks (sessions will be separated for children and parents). Mindfulness sessions will be coordinated by experts in mindfulness techniques in children and adults respectively from the collaborator Institution "Spanish School of Transpersonal Development" Previous to the session, a 24-hour food recall questionnaire will be applied to offer a meal plan restricted in 500 kcal. The 24-R will be repeated at each session in order to make adjustments to the meal plan if necessary. Also a 60-minute walk 3 times a week will be recommended

In this group, children and their parents will receive information regarding what is a healthy diet and physical activity attached to the World Health Organization recommendations. The session will be coordinated by a pediatric endocrinologist. Previous to the session, a 24-hour food recall questionnaire will be applied to offer a meal plan restricted in 500 kcal. The 24-R will be repeated at each session in order to make adjustments to the meal plan when necessary. Also a 60-minute walk 3 times a week will be recommended

Outcomes

Primary Outcome Measures

stress
Change in salivary cortisol from baseline to end of intervention

Secondary Outcome Measures

insulin resistance
Change in homeostasis model assessment from baseline to the end of intervention
appetite hormones
Change in serum ghrelin and leptin from baseline to the end of intervention
weight
Change in BMI from baseline to the end of intervention
BMI relapse
Change in BMI from the end of intervention to 8 weeks later

Full Information

First Posted
March 6, 2018
Last Updated
November 11, 2019
Sponsor
Coordinación de Investigación en Salud, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT03495310
Brief Title
Effect of Mindfulness on Stress, Appetite Hormones and Body Weight of Obese Schoolchildren. Controlled Clinical Trial
Acronym
Mindfulness
Official Title
Effect of Mindfulness on Some Hormones That Regulate Stress and Appetite, and on the Body Weight of Obese Schoolchildren. Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Coordinación de Investigación en Salud, Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood, Mindfulness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness
Arm Type
Experimental
Arm Description
In this group, children and their parents will receive a mindfulness session once a week, with a duration of 90 minutes, during 8 weeks (sessions will be separated for children and parents). Mindfulness sessions will be coordinated by experts in mindfulness techniques in children and adults respectively from the collaborator Institution "Spanish School of Transpersonal Development" Previous to the session, a 24-hour food recall questionnaire will be applied to offer a meal plan restricted in 500 kcal. The 24-R will be repeated at each session in order to make adjustments to the meal plan if necessary. Also a 60-minute walk 3 times a week will be recommended
Arm Title
Control
Arm Type
No Intervention
Arm Description
In this group, children and their parents will receive information regarding what is a healthy diet and physical activity attached to the World Health Organization recommendations. The session will be coordinated by a pediatric endocrinologist. Previous to the session, a 24-hour food recall questionnaire will be applied to offer a meal plan restricted in 500 kcal. The 24-R will be repeated at each session in order to make adjustments to the meal plan when necessary. Also a 60-minute walk 3 times a week will be recommended
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Other Intervention Name(s)
method on the concentration of attention
Intervention Description
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
Primary Outcome Measure Information:
Title
stress
Description
Change in salivary cortisol from baseline to end of intervention
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
insulin resistance
Description
Change in homeostasis model assessment from baseline to the end of intervention
Time Frame
8 weeks
Title
appetite hormones
Description
Change in serum ghrelin and leptin from baseline to the end of intervention
Time Frame
8 weeks
Title
weight
Description
Change in BMI from baseline to the end of intervention
Time Frame
8 weeks
Title
BMI relapse
Description
Change in BMI from the end of intervention to 8 weeks later
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: obesity (BMI> 2 SD) and stress (Spence scale> 60) - Exclusion Criteria: taking any antihyperglycemic medication obesity of endocrinological origin do not wish to participate
Facility Information:
Facility Name
Mardia Lopez Alarcon
City
Cuauhtémoc
State/Province
Ciudad DE Mexico
ZIP/Postal Code
06720
Country
Mexico
Facility Name
Unit or research in Medical Nutrition, Pediatric Hospital CMN "Siglo XXI", Instituto Mexicano del Seguro Social
City
Mexico City
ZIP/Postal Code
06720
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Mindfulness on Stress, Appetite Hormones and Body Weight of Obese Schoolchildren. Controlled Clinical Trial

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