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

NCT03495310 | Completed DMC

• 1 other identifier: R-2017-785-096
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity, Childhood; Mindfulness

Outcome Measures

Primary Outcomes (1)

• stress

  Change in salivary cortisol from baseline to end of intervention

  8 weeks

Secondary Outcomes (4)

• insulin resistance

  8 weeks

• appetite hormones

  8 weeks

• weight

  8 weeks

• BMI relapse

  8 weeks

Study Arms (2)

Mindfulness

EXPERIMENTAL

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

Behavioral: Mindfulness

Control

NO INTERVENTION

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

Interventions

Mindfulness BEHAVIORAL

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

Also known as: method on the concentration of attention

Mindfulness

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (2)

Mardia Lopez Alarcon

Cuauhtémoc, Mexico City, 06720, Mexico

Location

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

Mexico City, 06720, Mexico

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Mardia Lopez-Alarcon

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: April 12, 2018
• Study Start: September 1, 2018
• Primary Completion: May 30, 2019
• Study Completion: August 30, 2019
• Last Updated: November 13, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2)