Efficacy of a Mindful-eating Program to Reduce Emotional Eating

Study Overview
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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.

Official Title
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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

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Behavioral: Mindful Eating


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>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<br>* 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.<br>|
| No Intervention: Control<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Overweight, Mindful Eating, Primary Care, Randomized controlled trial (RCT)