Efficacy of a Mindful-eating Program to Reduce Emotional Eating

Efficacy of a Mindful Eating Program to Reduce Emotional Eating in Patients Suffering From Overweight or Obesity in Primary Care Settings: a Cluster Randomized Controlled Clinical Trial Protocol

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Behavioral: Mindful Eating

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Zaragoza, Spain, 50009
    • Department of Psychiatry. Miguel Servet University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic data Gender, age, marital status, education, occupation, economical level		Baseline in experimental and control groups
Five Facet Mindfulness Questionnaire	The FFMQ-short form is a 24-item questionnaire that measures five aspects of mindfulness and there is a Spanish version based on it with appropriate psychometrics. The five facets the FFMQ measures are: observing (α = 81), describing (α = .87), acting with awareness (5 items, α = .83), non-judging to (5 items, α = .83) and non-reacting of (5 items, α = .75) inner experience. The participants indicate on a 5-point Likert scale the degree in which each item is generally true for them, ranging from 1 ("never or very rarely true") to 5 ("very often or always true").	Baseline in experimental and control groups
Five Facet Mindfulness Questionnaire	The FFMQ-short form is a 24-item questionnaire that measures five aspects of mindfulness and there is a Spanish version based on it with appropriate psychometrics. The five facets the FFMQ measures are: observing (α = 81), describing (α = .87), acting with awareness (5 items, α = .83), non-judging to (5 items, α = .83) and non-reacting of (5 items, α = .75) inner experience. The participants indicate on a 5-point Likert scale the degree in which each item is generally true for them, ranging from 1 ("never or very rarely true") to 5 ("very often or always true").	Post-treatment 8 weeks from baseline in experimental and control groups
Five Facet Mindfulness Questionnaire	The FFMQ-short form is a 24-item questionnaire that measures five aspects of mindfulness and there is a Spanish version based on it with appropriate psychometrics. The five facets the FFMQ measures are: observing (α = 81), describing (α = .87), acting with awareness (5 items, α = .83), non-judging to (5 items, α = .83) and non-reacting of (5 items, α = .75) inner experience. The participants indicate on a 5-point Likert scale the degree in which each item is generally true for them, ranging from 1 ("never or very rarely true") to 5 ("very often or always true").	twelve-months follow-up in experimental and control groups
Self-Compassion Scale	It is the most used self-report instrument to measure self-compassion and it is divided into six subscales: Self-Kindness; Self-Judgment; Common Humanity; Isolation; Mindfulness; and Over-Identification. The items can be rated on a five-point Likert-type scale with 1 indicating "almost never" and 5 indicating "almost always". After reversing the negatively formulated items, a total score can be calculated, which may range from 24 to 120, with higher scores indicating greater self-compassion	Baseline in experimental and control groups
Self-Compassion Scale	It is the most used self-report instrument to measure self-compassion and it is divided into six subscales: Self-Kindness; Self-Judgment; Common Humanity; Isolation; Mindfulness; and Over-Identification. The items can be rated on a five-point Likert-type scale with 1 indicating "almost never" and 5 indicating "almost always". After reversing the negatively formulated items, a total score can be calculated, which may range from 24 to 120, with higher scores indicating greater self-compassion	Post-treatment 8 weeks from baseline in experimental and control groups
Self-Compassion Scale	It is the most used self-report instrument to measure self-compassion and it is divided into six subscales: Self-Kindness; Self-Judgment; Common Humanity; Isolation; Mindfulness; and Over-Identification. The items can be rated on a five-point Likert-type scale with 1 indicating "almost never" and 5 indicating "almost always". After reversing the negatively formulated items, a total score can be calculated, which may range from 24 to 120, with higher scores indicating greater self-compassion	twelve-months follow-up in experimental and control groups
Mindful Eating Scale	The MES scale has 28 items, including six factors: acceptance (α = .89), awareness (α = .82), non-reactivity (α = .77), act with awareness (α = .81), routine (α = .75) and unstructured eating (α = .60). Items can be rated on a 4-point Likert-type scale, with 1 indicating "never" and 4 indicating "very often".	Baseline in experimental and control groups
Mindful Eating Scale	The MES scale has 28 items, including six factors: acceptance (α = .89), awareness (α = .82), non-reactivity (α = .77), act with awareness (α = .81), routine (α = .75) and unstructured eating (α = .60). Items can be rated on a 4-point Likert-type scale, with 1 indicating "never" and 4 indicating "very often".	Post-treatment 8 weeks from baseline in experimental and control groups
Mindful Eating Scale	The MES scale has 28 items, including six factors: acceptance (α = .89), awareness (α = .82), non-reactivity (α = .77), act with awareness (α = .81), routine (α = .75) and unstructured eating (α = .60). Items can be rated on a 4-point Likert-type scale, with 1 indicating "never" and 4 indicating "very often".	twelve-months follow-up in experimental and control groups
Bulimic Investigatory Test	The BITE is very used to measure the presence and severity of bulimic symptoms in nonclinical samples. Normative values for BITE total and sub-scale scores in clinical and non-clinical samples are reported. The scale includes in the Symptoms subscale (30 yes-no items; range =0-30) and Severity subscale (6 dimensional items addressing specific bulimic behaviors; range=0-39). In addition to these standars scores, another measure was derived from the BITE-the reported frequency of bingeing	Baseline in experimental and control groups
Bulimic Investigatory Test	The BITE is very used to measure the presence and severity of bulimic symptoms in nonclinical samples. Normative values for BITE total and sub-scale scores in clinical and non-clinical samples are reported. The scale includes in the Symptoms subscale (30 yes-no items; range =0-30) and Severity subscale (6 dimensional items addressing specific bulimic behaviors; range=0-39). In addition to these standars scores, another measure was derived from the BITE-the reported frequency of bingeing	Post-treatment 8 weeks from baseline in experimental and control groups
Bulimic Investigatory Test	The BITE is very used to measure the presence and severity of bulimic symptoms in nonclinical samples. Normative values for BITE total and sub-scale scores in clinical and non-clinical samples are reported. The scale includes in the Symptoms subscale (30 yes-no items; range =0-30) and Severity subscale (6 dimensional items addressing specific bulimic behaviors; range=0-39). In addition to these standars scores, another measure was derived from the BITE-the reported frequency of bingeing	twelve-months follow-up in experimental and control groups
Eating Attitude test (EAT-26)	The EAT-26 had three subscales Dieting, Bulimia and Food Preocupation, and Oral Control. It is and abbreviated version of the original EAT-40, having an excellent correlation. In the EAT-26 each item is answered on a 6-point Lickert scale and if the scoring is 20 or higher the patient should look for professional advice. The Eat-26 had an elevated reliability	Baseline in experimental and control groups
Eating Attitude test (EAT-26)	The EAT-26 had three subscales Dieting, Bulimia and Food Preocupation, and Oral Control. It is and abbreviated version of the original EAT-40, having an excellent correlation. In the EAT-26 each item is answered on a 6-point Lickert scale and if the scoring is 20 or higher the patient should look for professional advice. The Eat-26 had an elevated reliability	Post-treatment 8 weeks from baseline in experimental and control groups
Eating Attitude test (EAT-26)	The EAT-26 had three subscales Dieting, Bulimia and Food Preocupation, and Oral Control. It is and abbreviated version of the original EAT-40, having an excellent correlation. In the EAT-26 each item is answered on a 6-point Lickert scale and if the scoring is 20 or higher the patient should look for professional advice. The Eat-26 had an elevated reliability	twelve-months follow-up in experimental and control groups
Weight	Weight measurement will be quantified in kilograms using a digital scale	Baseline in experimental and control groups
Weight	Weight measurement will be quantified in kilograms using a digital scale	twelve-months follow-up in experimental and control groups
Abdominal perimeter	Abdominal perimeter measurement will be quantified in centimetres using a measuring tape	Baseline in experimental and control groupsw-up in experimental and control groups
Abdominal perimeter	Abdominal perimeter measurement will be quantified in centimetres using a measuring tape	twelve-months follow-up in experimental and control groups
Height	Height measurement will be quantified in centimetres using a measuring tape	Baseline in experimental and control groups
Height	Height measurement will be quantified in centimetres using a measuring tape	twelve-months follow-up in experimental and control groups
Cholesterol total	Cholesterol total measurement will be quantified mg/dL using a blood test	Baseline in experimental and control groups
Cholesterol total	Cholesterol total measurement will be quantified mg/dL using a blood test	twelve-months follow-up in experimental and control groups
LDL	LDL measurement will be quantified mg/dL using a blood test	Baseline in experimental and control groups
LDL	LDL measurement will be quantified mg/dL using a blood test	twelve-months follow-up in experimental and control groups
HDL	HDL measurement will be quantified mg/dL using a blood test	Baseline in experimental and control groups
HDL	HDL measurement will be quantified mg/dL using a blood test	twelve-months follow-up in experimental and control groups
Glucose	Glucose measurement will be quantified mg/dL using a blood test	Baseline in experimental and control groups
Glucose	Glucose measurement will be quantified mg/dL using a blood test	twelve-months follow-up in experimental and control groups
Alanine aminotransferase	Alanine aminotransferase measurement will be quantified U/L using a blood test	Baseline in experimental and control groups
Alanine aminotransferase	Alanine aminotransferase measurement will be quantified U/L using a blood test	twelve-months follow-up in experimental and control groups
Glycated haemoglobin	Glycated haemoglobin measurement will be quantified in percentage (%) using a blood test	Baseline in experimental and control groups
Glycated haemoglobin	Glycated haemoglobin measurement will be quantified in percentage (%) using a blood test	twelve-months follow-up in experimental and control groups
General Anxiety Disorder	It is one of the most frequently used diagnostic self-report scales for screening, diagnosis and anxiety disorder severity assessment, defined as an excessive anxiety and worry (apprehensive expectation) related to a number of events or activities, associated to experiencing difficulties to control that worry. Items are rated on a 4-point Likert-type scale (between 0 = "not at all" and 3 = "nearly every day"). The GAD-7 inquires about events happening over the last two weeks, in order to know how often the patient has been bothered by them	Baseline in experimental and control groups
General Anxiety Disorder	It is one of the most frequently used diagnostic self-report scales for screening, diagnosis and anxiety disorder severity assessment, defined as an excessive anxiety and worry (apprehensive expectation) related to a number of events or activities, associated to experiencing difficulties to control that worry. Items are rated on a 4-point Likert-type scale (between 0 = "not at all" and 3 = "nearly every day"). The GAD-7 inquires about events happening over the last two weeks, in order to know how often the patient has been bothered by them	twelve-months follow-up in experimental and control groups
Patient Health Questionnaire	This scale is one of the most widely used questionnaires that assess the intensity of depression in pharmacological and psychological studies, it is useful to monitor changes experienced by patients over time. Through items like "Little interest or pleasure in doing things" and using a Liker-type scale from 0 ("not at all") to 3 ("nearly every day"), the PHQ-9 reflects the experience of participants during the last two weeks.	Baseline in experimental and control groups
Patient Health Questionnaire	This scale is one of the most widely used questionnaires that assess the intensity of depression in pharmacological and psychological studies, it is useful to monitor changes experienced by patients over time. Through items like "Little interest or pleasure in doing things" and using a Liker-type scale from 0 ("not at all") to 3 ("nearly every day"), the PHQ-9 reflects the experience of participants during the last two weeks.	twelve-months follow-up in experimental and control groups
The diastolic blood pressure (DBP) and the systolic blood pressure (SBP)	In order to evaluate the vital signs we will use a vascular screening system, in the version VaSera VS-1500.	Baseline in experimental and control groups
The diastolic blood pressure (DBP) and the systolic blood pressure (SBP)	In order to evaluate the vital signs we will use a vascular screening system, in the version VaSera VS-1500.	twelve-months follow-up in experimental and control groups

Collaborators and Investigators

• Sponsor: Hospital Miguel Servet
• Collaborators: Dharamsala Institute of Mindfulness and Psychotherapy of Zaragoza
• Investigators: Principal Investigator: Javier García-Campayo, PhD, Miguel Servet Hospital and University of Zaragoza

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ACTUAL): August 31, 2019
• Study Completion (ACTUAL): August 30, 2020

Study Registration Dates

• First Submitted: April 19, 2019
• First Submitted That Met QC Criteria: April 24, 2019
• First Posted (ACTUAL): April 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Obesity; Primary Care; Overweight; Randomized controlled trial (RCT); Mindful Eating
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: 05/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Once available, the results of the trial will be presented at national and international conferences and in peer-reviewed journal publications. 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. Data will become available following each publication with no end date for replicating the results of the trial or for any analytical purpose that is related to achieve aims in the original proposal. The database will be encrypted and password protected (passwords will be provided by the corresponding author to researchers that meet the referred criteria).
• IPD Sharing 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
• IPD Sharing 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No