Efficacy of a Mindful-eating Program to Reduce Emotional Eating

NCT03927534 | Completed

• 1 other identifier: 05/2019
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight and Obesity

Keywords

Obesity; Overweight; Mindful Eating; Primary Care; Randomized controlled trial (RCT)

Outcome Measures

Primary Outcomes (3)

• The Dutch Eating Behavior Questionnaire

  It was designed to measure eating styles that may attenuate or contribute to the development of overweight. It comprises three scales that measure emotional, external and restrained eating. The Spanish version of the DEBQ has 33 items, 13 of them referred to the emotional eating scale (e.g., "Desire to eat when irritated"), and 10 items referring to the external (e.g., "Eating when you feel lonely") and restrictive (e.g., "Difficult to resist delicious food") scales, respectively. The items can be rated on a five-point likert scale with 1 indicating "never" and 5 indicating "very often".

  Baseline in experimental and control groups.

• The Dutch Eating Behavior Questionnaire

  It was designed to measure eating styles that may attenuate or contribute to the development of overweight. It comprises three scales that measure emotional, external and restrained eating. The Spanish version of the DEBQ has 33 items, 13 of them referred to the emotional eating scale (e.g., "Desire to eat when irritated"), and 10 items referring to the external (e.g., "Eating when you feel lonely") and restrictive (e.g., "Difficult to resist delicious food") scales, respectively. The items can be rated on a five-point likert scale with 1 indicating "never" and 5 indicating "very often".

  Post-treatment 8 weeks from baseline in experimental and control groups

• The Dutch Eating Behavior Questionnaire

  It was designed to measure eating styles that may attenuate or contribute to the development of overweight. It comprises three scales that measure emotional, external and restrained eating. The Spanish version of the DEBQ has 33 items, 13 of them referred to the emotional eating scale (e.g., "Desire to eat when irritated"), and 10 items referring to the external (e.g., "Eating when you feel lonely") and restrictive (e.g., "Difficult to resist delicious food") scales, respectively. The items can be rated on a five-point likert scale with 1 indicating "never" and 5 indicating "very often".

  twelve-months follow-up in experimental and control groups

Secondary Outcomes (40)

• Sociodemographic data Gender, age, marital status, education, occupation, economical level

  Baseline in experimental and control groups

• Five Facet Mindfulness Questionnaire

  Baseline in experimental and control groups

• Five Facet Mindfulness Questionnaire

  Post-treatment 8 weeks from baseline in experimental and control groups

• Five Facet Mindfulness Questionnaire

  twelve-months follow-up in experimental and control groups

• Self-Compassion Scale

  Baseline in experimental and control groups

Study Arms (2)

Experimental

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.

Behavioral: Mindful Eating

Control

NO INTERVENTION

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.

Interventions

Mindful Eating 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.

Experimental

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Miguel Servet: lead
• Dharamsala Institute of Mindfulness and Psychotherapy of Zaragoza: collaborator

Study Sites (1)

Department of Psychiatry. Miguel Servet University Hospital

Zaragoza, 50009, Spain

Location

Related Publications (12)

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  PMID: 12457290 BACKGROUND

• 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.

  PMID: 17469900 BACKGROUND

• 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.

  PMID: 26168376 BACKGROUND

• 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.

  PMID: 22021603 BACKGROUND

• 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.

  PMID: 27280721 BACKGROUND

• 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.

  PMID: 17900040 BACKGROUND

• 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.

  PMID: 23102183 BACKGROUND

• 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.

  PMID: 29802533 BACKGROUND

• 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.

  PMID: 26627097 BACKGROUND

• 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.

  PMID: 23876574 BACKGROUND

• 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.

  PMID: 26563148 BACKGROUND

• 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.

  PMID: 31753880 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Javier García-Campayo, PhD

  Miguel Servet Hospital and University of Zaragoza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: April 25, 2019
• Study Start: May 1, 2019
• Primary Completion: August 31, 2019
• Study Completion: August 30, 2020
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will become available following each publication with no end date for replicating the results of the trial or for any analytical purpose
• Access Criteria: Due to the clinical nature of the study and considering ethical concerns, the data (anonymised and completely de-identified) generated by this trial will be made available upon request to researchers a) who provide a methodologically sound proposal and b) whose proposed use of the data has been approved by an independent ethical review committee

Locations

ES (1)