Efficacy of a Mindful-eating Program to Reduce Emotional Eating

Sponsor

Hospital Miguel Servet (Other)

Overall Status

Completed

CT.gov ID

NCT03927534

Collaborator

Dharamsala Institute of Mindfulness and Psychotherapy of Zaragoza (Other)

Enrollment

Location

Arms

Actual Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity	Behavioral: Mindful Eating	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2019

Actual Primary Completion Date :

Aug 31, 2019

Actual Study Completion Date :

Aug 30, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

The Dutch Eating Behavior Questionnaire [Baseline in experimental and control groups.]
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".
The Dutch Eating Behavior Questionnaire [Post-treatment 8 weeks from baseline in experimental and control groups]
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".
The Dutch Eating Behavior Questionnaire [twelve-months follow-up in experimental and control groups]
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".

Secondary Outcome Measures

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]
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").
Five Facet Mindfulness Questionnaire [Post-treatment 8 weeks from baseline in experimental and control groups]
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").
Five Facet Mindfulness Questionnaire [twelve-months follow-up in experimental and control groups]
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").
Self-Compassion Scale [Baseline in experimental and control groups]
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
Self-Compassion Scale [Post-treatment 8 weeks from baseline in experimental and control groups]
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
Self-Compassion Scale [twelve-months follow-up in experimental and control groups]
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
Mindful Eating Scale [Baseline in experimental and control groups]
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".
Mindful Eating Scale [Post-treatment 8 weeks from baseline in experimental and control groups]
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".
Mindful Eating Scale [twelve-months follow-up in experimental and control groups]
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".
Bulimic Investigatory Test [Baseline in experimental and control groups]
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
Bulimic Investigatory Test [Post-treatment 8 weeks from baseline in experimental and control groups]
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
Bulimic Investigatory Test [twelve-months follow-up in experimental and control groups]
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
Eating Attitude test (EAT-26) [Baseline in experimental and control groups]
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
Eating Attitude test (EAT-26) [Post-treatment 8 weeks from baseline in experimental and control groups]
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
Eating Attitude test (EAT-26) [twelve-months follow-up in experimental and control groups]
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
Weight [Baseline in experimental and control groups]
Weight measurement will be quantified in kilograms using a digital scale
Weight [twelve-months follow-up in experimental and control groups]
Weight measurement will be quantified in kilograms using a digital scale
Abdominal perimeter [Baseline in experimental and control groupsw-up in experimental and control groups]
Abdominal perimeter measurement will be quantified in centimetres using a measuring tape
Abdominal perimeter [twelve-months follow-up in experimental and control groups]
Abdominal perimeter measurement will be quantified in centimetres using a measuring tape
Height [Baseline in experimental and control groups]
Height measurement will be quantified in centimetres using a measuring tape
Height [twelve-months follow-up in experimental and control groups]
Height measurement will be quantified in centimetres using a measuring tape
Cholesterol total [Baseline in experimental and control groups]
Cholesterol total measurement will be quantified mg/dL using a blood test
Cholesterol total [twelve-months follow-up in experimental and control groups]
Cholesterol total measurement will be quantified mg/dL using a blood test
LDL [Baseline in experimental and control groups]
LDL measurement will be quantified mg/dL using a blood test
LDL [twelve-months follow-up in experimental and control groups]
LDL measurement will be quantified mg/dL using a blood test
HDL [Baseline in experimental and control groups]
HDL measurement will be quantified mg/dL using a blood test
HDL [twelve-months follow-up in experimental and control groups]
HDL measurement will be quantified mg/dL using a blood test
Glucose [Baseline in experimental and control groups]
Glucose measurement will be quantified mg/dL using a blood test
Glucose [twelve-months follow-up in experimental and control groups]
Glucose measurement will be quantified mg/dL using a blood test
Alanine aminotransferase [Baseline in experimental and control groups]
Alanine aminotransferase measurement will be quantified U/L using a blood test
Alanine aminotransferase [twelve-months follow-up in experimental and control groups]
Alanine aminotransferase measurement will be quantified U/L using a blood test
Glycated haemoglobin [Baseline in experimental and control groups]
Glycated haemoglobin measurement will be quantified in percentage (%) using a blood test
Glycated haemoglobin [twelve-months follow-up in experimental and control groups]
Glycated haemoglobin measurement will be quantified in percentage (%) using a blood test
General Anxiety Disorder [Baseline in experimental and control groups]
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
General Anxiety Disorder [twelve-months follow-up in experimental and control groups]
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
Patient Health Questionnaire [Baseline in experimental and control groups]
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.
Patient Health Questionnaire [twelve-months follow-up in experimental and control groups]
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.
The diastolic blood pressure (DBP) and the systolic blood pressure (SBP) [Baseline in experimental and control groups]
In order to evaluate the vital signs we will use a vascular screening system, in the version VaSera VS-1500.
The diastolic blood pressure (DBP) and the systolic blood pressure (SBP) [twelve-months follow-up in experimental and control groups]
In order to evaluate the vital signs we will use a vascular screening system, in the version VaSera VS-1500.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.