Efficacy of a Mindful-eating Program to Reduce Emotional Eating

NCT ID: NCT03927534

Last Updated: 2021-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-08-30

Brief Summary

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Mindfulness-Based Interventions have been applied in different fields to improve physical and psychological health. However, little is known about its applicability and effectiveness in Spanish adults with overweight and obesity. The aim of the present study protocol is to evaluate the feasibility and efficacy of an adapted MBI programme to reduce emotional eating in adults with overweight and obesity in primary care (PC) settings.

Detailed Description

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This study is a multi-centre, two-armed randomized controlled trial (RCT), with pre-treatment, post-treatment and 1-year follow-up measures, and a 1:1 allocation rate between groups. Patients from four mental health units in Zaragoza (Spain) will be randomly assigned to two different parallel conditions, with one psychological intervention group ('ME + TAU') and usual treatment ('TAU alone') managed by their general practitioner (GP), to test the superiority of 'ME + TAU' provision compared with 'TAU alone' provision. For ethical reasons, those patients allocated to 'TAU alone' will be offered the ME programme after finishing the trial at 1-year follow-up.

Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental

Mindful Eating program is apply face to face 7 sessions of 120 minutes/session. ME is apply in groups of 10-12 people in traditional format. Written material and sound recordings will be offered as support elements. The estimated duration of the face to face program is two months.

Group Type EXPERIMENTAL

Mindful Eating

Intervention Type BEHAVIORAL

The ME group will be composed by 7 weekly group sessions with a minimum duration of two hours, mixing theoretical contents with practices. Sessions will always be the same day of the week, except for bank holidays or eventualities, and will be conducted by a psychologist specially trained and certified in ME with experience in leading mindfulness groups. Group sizes will range between 10 and 12 participants. At the end of each session, participants will receive theoretical contents and homework activities to be practiced along the week.

Control

Treatment As Usual (TAU) in Primary Care (PC) is any kind of treatment administered by the GP to the patient with overweight and obesity. According to nutritional status, overweight or obesity, as well as the presence of co-morbidity, different actions can comprise the treatment offered at a PC level. For individuals presenting with overweight (BMI 25-29.9 kg/m2) but with no co-morbidities, PC teams organise care plans to enable them to achieve a normal BMI range (BMI 18.5-24.9 kg/m2). In case of suicide risk, severe social dysfunction or worsening of symptoms, it is recommended that patients are referred to mental health facilities.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindful Eating

The ME group will be composed by 7 weekly group sessions with a minimum duration of two hours, mixing theoretical contents with practices. Sessions will always be the same day of the week, except for bank holidays or eventualities, and will be conducted by a psychologist specially trained and certified in ME with experience in leading mindfulness groups. Group sizes will range between 10 and 12 participants. At the end of each session, participants will receive theoretical contents and homework activities to be practiced along the week.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age between 45-75 years
* Have overweight or obesity condition based in BMI (Body Mass Index). Individuals with BMI of 25 or more.
* Have two of these three risk: sedentary lifestyle, poor diet and binge episodes.
* Ability to understand oral and written Spanish.
* Willingness to participate in the study and signing informed consent.

Exclusion Criteria

* Any diagnosis of a disease that may affect the central nervous system (brain condition, traumatic brain injury, dementia, etc).
* Other psychiatric diagnoses or acute psychiatric illness (substance dependence or abuse, history of schizophrenia or other psychotic disorders, etc.), except for anxiety disorder or personality disorders.
* Presence of delusional ideas or hallucinations whether consistent or not with mood.
* Suicide risk.
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dharamsala Institute of Mindfulness and Psychotherapy of Zaragoza

UNKNOWN

Sponsor Role collaborator

Hospital Miguel Servet

OTHER

Sponsor Role lead

Responsible Party

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Javier Garcia Campayo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Javier GarcĂ­a-Campayo, PhD

Role: PRINCIPAL_INVESTIGATOR

Miguel Servet Hospital and University of Zaragoza

Locations

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Department of Psychiatry. Miguel Servet University Hospital

Zaragoza, , Spain

Site Status

Countries

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Spain

References

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Rossner S. Obesity: the disease of the twenty-first century. Int J Obes Relat Metab Disord. 2002 Dec;26 Suppl 4:S2-4. doi: 10.1038/sj.ijo.0802209.

Reference Type BACKGROUND
PMID: 12457290 (View on PubMed)

Mann T, Tomiyama AJ, Westling E, Lew AM, Samuels B, Chatman J. Medicare's search for effective obesity treatments: diets are not the answer. Am Psychol. 2007 Apr;62(3):220-33. doi: 10.1037/0003-066X.62.3.220.

Reference Type BACKGROUND
PMID: 17469900 (View on PubMed)

Holzel BK, Lazar SW, Gard T, Schuman-Olivier Z, Vago DR, Ott U. How Does Mindfulness Meditation Work? Proposing Mechanisms of Action From a Conceptual and Neural Perspective. Perspect Psychol Sci. 2011 Nov;6(6):537-59. doi: 10.1177/1745691611419671.

Reference Type BACKGROUND
PMID: 26168376 (View on PubMed)

Kristeller JL, Hallett CB. An Exploratory Study of a Meditation-based Intervention for Binge Eating Disorder. J Health Psychol. 1999 May;4(3):357-63. doi: 10.1177/135910539900400305.

Reference Type BACKGROUND
PMID: 22021603 (View on PubMed)

Medina WL, Wilson D, de Salvo V, Vannucchi B, de Souza EL, Lucena L, Sarto HM, Modrego-Alarcon M, Garcia-Campayo J, Demarzo M. Effects of Mindfulness on Diabetes Mellitus: Rationale and Overview. Curr Diabetes Rev. 2017;13(2):141-147. doi: 10.2174/1573399812666160607074817.

Reference Type BACKGROUND
PMID: 27280721 (View on PubMed)

Rosenzweig S, Reibel DK, Greeson JM, Edman JS, Jasser SA, McMearty KD, Goldstein BJ. Mindfulness-based stress reduction is associated with improved glycemic control in type 2 diabetes mellitus: a pilot study. Altern Ther Health Med. 2007 Sep-Oct;13(5):36-8.

Reference Type BACKGROUND
PMID: 17900040 (View on PubMed)

Miller CK, Kristeller JL, Headings A, Nagaraja H, Miser WF. Comparative effectiveness of a mindful eating intervention to a diabetes self-management intervention among adults with type 2 diabetes: a pilot study. J Acad Nutr Diet. 2012 Nov;112(11):1835-42. doi: 10.1016/j.jand.2012.07.036.

Reference Type BACKGROUND
PMID: 23102183 (View on PubMed)

Fanning J, Osborn CY, Lagotte AE, Mayberry LS. Relationships between dispositional mindfulness, health behaviors, and hemoglobin A1c among adults with type 2 diabetes. J Behav Med. 2018 Dec;41(6):798-805. doi: 10.1007/s10865-018-9938-3. Epub 2018 May 25.

Reference Type BACKGROUND
PMID: 29802533 (View on PubMed)

Mantzios M, Wilson JC. Mindfulness, Eating Behaviours, and Obesity: A Review and Reflection on Current Findings. Curr Obes Rep. 2015 Mar;4(1):141-6. doi: 10.1007/s13679-014-0131-x.

Reference Type BACKGROUND
PMID: 26627097 (View on PubMed)

Godsey J. The role of mindfulness based interventions in the treatment of obesity and eating disorders: an integrative review. Complement Ther Med. 2013 Aug;21(4):430-9. doi: 10.1016/j.ctim.2013.06.003. Epub 2013 Jul 9.

Reference Type BACKGROUND
PMID: 23876574 (View on PubMed)

Mason AE, Epel ES, Kristeller J, Moran PJ, Dallman M, Lustig RH, Acree M, Bacchetti P, Laraia BA, Hecht FM, Daubenmier J. Effects of a mindfulness-based intervention on mindful eating, sweets consumption, and fasting glucose levels in obese adults: data from the SHINE randomized controlled trial. J Behav Med. 2016 Apr;39(2):201-13. doi: 10.1007/s10865-015-9692-8. Epub 2015 Nov 12.

Reference Type BACKGROUND
PMID: 26563148 (View on PubMed)

Morillo Sarto H, Barcelo-Soler A, Herrera-Mercadal P, Pantilie B, Navarro-Gil M, Garcia-Campayo J, Montero-Marin J. Efficacy of a mindful-eating programme to reduce emotional eating in patients suffering from overweight or obesity in primary care settings: a cluster-randomised trial protocol. BMJ Open. 2019 Nov 21;9(11):e031327. doi: 10.1136/bmjopen-2019-031327.

Reference Type DERIVED
PMID: 31753880 (View on PubMed)

Other Identifiers

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05/2019

Identifier Type: -

Identifier Source: org_study_id

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