Obesity, ChildhoodMindfulnessNCT03495310
Effect of Mindfulness on Stress, Appetite Hormones and Body Weight of Obese Schoolchildren. Controlled Clinical Trial
A study testing Mindfulness in people with Obesity, Childhood and Mindfulness, run by Coordinación de Investigación en Salud, Mexico at 2 sites in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Obesity, Childhood, Mindfulness
- What is being tested?
- Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesMexico
- Study dates
- 1 Sep 2018to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- obesity (BMI> 2 SD) and stress (Spence scale> 60) -
Who cannot join
- taking any antihyperglycemic medication
- obesity of endocrinological origin
- do not wish to participate
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
Mardia Lopez Alarcon
Cuauhtémoc, Mexico City, 06720
Unit or research in Medical Nutrition, Pediatric Hospital CMN "Siglo XXI", Instituto Mexicano del Seguro Social
Mexico City, 06720
About this study
Official title: Effect of Mindfulness on Some Hormones That Regulate Stress and Appetite, and on the Body Weight of Obese Schoolchildren. Controlled Clinical Trial
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.
Read the 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.
- Conditions
- Obesity, Childhood, Mindfulness
- Being tested
- Mindfulness
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
Also called method on the concentration of attention
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
stress
Change in salivary cortisol from baseline to end of intervention
Measured: 8 weeks
Secondary outcomes (4)
insulin resistance
Change in homeostasis model assessment from baseline to the end of intervention
Measured: 8 weeks
appetite hormones
Change in serum ghrelin and leptin from baseline to the end of intervention
Measured: 8 weeks
weight
Change in BMI from baseline to the end of intervention
Measured: 8 weeks
BMI relapse
Change in BMI from the end of intervention to 8 weeks later
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start1 Sep 2018
- Primary completion30 May 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mardia Guadalupe Lopez Alarcon, Coordinación de Investigación en Salud, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495310
- Sponsor's protocol ID
- R-2017-785-096
- Acronym
- Mindfulness
- Status last verified
- Nov 2019
- First submitted
- 6 Mar 2018
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mindfulness on Some Hormones That Regulate Stress and Appetite, and on the Body Weight of Obese Schoolchildren. Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03495310
- Acronym / sponsor ID
- Mindfulness / R-2017-785-096
- Conditions
- Obesity, Childhood, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: MindfulnessIn 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 |
| 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 |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- obesity (BMI> 2 SD) and stress (Spence scale> 60) -
Key exclusion criteria (3 listed)
- taking any antihyperglycemic medication
- obesity of endocrinological origin
- do not wish to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindfulnessAlso: method on the concentration of attentionMindfulness 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 | Behavioural | Mindfulness |
Primary outcome
stress
Time frame: 8 weeks
Change in salivary cortisol from baseline to end of intervention
4 secondary outcomes
insulin resistance
Time frame: 8 weeks
appetite hormones
Time frame: 8 weeks
weight
Time frame: 8 weeks
BMI relapse
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness in people with Obesity, Childhood and Mindfulness, run by Coordinación de Investigación en Salud, Mexico at 2 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stress (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019; AzTrials last refreshed its copy on 8 Nov 2026.