Back to resultsEfficacy of a Mindful-eating Program to Reduce Emotional Eating
Primary Purpose
Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mindful Eating
Sponsored by
About this trial
This is an interventional treatment trial for Overweight and Obesity focused on measuring Obesity, Overweight, Mindful Eating, Primary Care, Randomized controlled trial (RCT)
Eligibility Criteria
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.
Sites / Locations
- Department of Psychiatry. Miguel Servet University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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".
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".
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".
Secondary Outcome Measures
Sociodemographic data Gender, age, marital status, education, occupation, economical level
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").
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").
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").
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
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
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
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".
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".
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".
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
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
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
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
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
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
Weight
Weight measurement will be quantified in kilograms using a digital scale
Weight
Weight measurement will be quantified in kilograms using a digital scale
Abdominal perimeter
Abdominal perimeter measurement will be quantified in centimetres using a measuring tape
Abdominal perimeter
Abdominal perimeter measurement will be quantified in centimetres using a measuring tape
Height
Height measurement will be quantified in centimetres using a measuring tape
Height
Height measurement will be quantified in centimetres using a measuring tape
Cholesterol total
Cholesterol total measurement will be quantified mg/dL using a blood test
Cholesterol total
Cholesterol total measurement will be quantified mg/dL using a blood test
LDL
LDL measurement will be quantified mg/dL using a blood test
LDL
LDL measurement will be quantified mg/dL using a blood test
HDL
HDL measurement will be quantified mg/dL using a blood test
HDL
HDL measurement will be quantified mg/dL using a blood test
Glucose
Glucose measurement will be quantified mg/dL using a blood test
Glucose
Glucose measurement will be quantified mg/dL using a blood test
Alanine aminotransferase
Alanine aminotransferase measurement will be quantified U/L using a blood test
Alanine aminotransferase
Alanine aminotransferase measurement will be quantified U/L using a blood test
Glycated haemoglobin
Glycated haemoglobin measurement will be quantified in percentage (%) using a blood test
Glycated haemoglobin
Glycated haemoglobin measurement will be quantified in percentage (%) using a blood test
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
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
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.
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.
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.
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.
Full Information
NCT ID
NCT03927534
First Posted
April 19, 2019
Last Updated
February 22, 2021
Sponsor
Hospital Miguel Servet
Collaborators
Dharamsala Institute of Mindfulness and Psychotherapy of Zaragoza
1. Study Identification
Unique Protocol Identification Number
NCT03927534
Brief Title
Efficacy of a Mindful-eating Program to Reduce Emotional Eating
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
August 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Miguel Servet
Collaborators
Dharamsala Institute of Mindfulness and Psychotherapy of Zaragoza
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Obesity, Overweight, Mindful Eating, Primary Care, Randomized controlled trial (RCT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindful Eating
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Dutch Eating Behavior Questionnaire
Description
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".
Time Frame
Baseline in experimental and control groups.
Title
The Dutch Eating Behavior Questionnaire
Description
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".
Time Frame
Post-treatment 8 weeks from baseline in experimental and control groups
Title
The Dutch Eating Behavior Questionnaire
Description
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".
Time Frame
twelve-months follow-up in experimental and control groups
Secondary Outcome Measure Information:
Title
Sociodemographic data Gender, age, marital status, education, occupation, economical level
Time Frame
Baseline in experimental and control groups
Title
Five Facet Mindfulness Questionnaire
Description
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").
Time Frame
Baseline in experimental and control groups
Title
Five Facet Mindfulness Questionnaire
Description
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").
Time Frame
Post-treatment 8 weeks from baseline in experimental and control groups
Title
Five Facet Mindfulness Questionnaire
Description
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").
Time Frame
twelve-months follow-up in experimental and control groups
Title
Self-Compassion Scale
Description
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
Time Frame
Baseline in experimental and control groups
Title
Self-Compassion Scale
Description
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
Time Frame
Post-treatment 8 weeks from baseline in experimental and control groups
Title
Self-Compassion Scale
Description
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
Time Frame
twelve-months follow-up in experimental and control groups
Title
Mindful Eating Scale
Description
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".
Time Frame
Baseline in experimental and control groups
Title
Mindful Eating Scale
Description
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".
Time Frame
Post-treatment 8 weeks from baseline in experimental and control groups
Title
Mindful Eating Scale
Description
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".
Time Frame
twelve-months follow-up in experimental and control groups
Title
Bulimic Investigatory Test
Description
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
Time Frame
Baseline in experimental and control groups
Title
Bulimic Investigatory Test
Description
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
Time Frame
Post-treatment 8 weeks from baseline in experimental and control groups
Title
Bulimic Investigatory Test
Description
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
Time Frame
twelve-months follow-up in experimental and control groups
Title
Eating Attitude test (EAT-26)
Description
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
Time Frame
Baseline in experimental and control groups
Title
Eating Attitude test (EAT-26)
Description
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
Time Frame
Post-treatment 8 weeks from baseline in experimental and control groups
Title
Eating Attitude test (EAT-26)
Description
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
Time Frame
twelve-months follow-up in experimental and control groups
Title
Weight
Description
Weight measurement will be quantified in kilograms using a digital scale
Time Frame
Baseline in experimental and control groups
Title
Weight
Description
Weight measurement will be quantified in kilograms using a digital scale
Time Frame
twelve-months follow-up in experimental and control groups
Title
Abdominal perimeter
Description
Abdominal perimeter measurement will be quantified in centimetres using a measuring tape
Time Frame
Baseline in experimental and control groupsw-up in experimental and control groups
Title
Abdominal perimeter
Description
Abdominal perimeter measurement will be quantified in centimetres using a measuring tape
Time Frame
twelve-months follow-up in experimental and control groups
Title
Height
Description
Height measurement will be quantified in centimetres using a measuring tape
Time Frame
Baseline in experimental and control groups
Title
Height
Description
Height measurement will be quantified in centimetres using a measuring tape
Time Frame
twelve-months follow-up in experimental and control groups
Title
Cholesterol total
Description
Cholesterol total measurement will be quantified mg/dL using a blood test
Time Frame
Baseline in experimental and control groups
Title
Cholesterol total
Description
Cholesterol total measurement will be quantified mg/dL using a blood test
Time Frame
twelve-months follow-up in experimental and control groups
Title
LDL
Description
LDL measurement will be quantified mg/dL using a blood test
Time Frame
Baseline in experimental and control groups
Title
LDL
Description
LDL measurement will be quantified mg/dL using a blood test
Time Frame
twelve-months follow-up in experimental and control groups
Title
HDL
Description
HDL measurement will be quantified mg/dL using a blood test
Time Frame
Baseline in experimental and control groups
Title
HDL
Description
HDL measurement will be quantified mg/dL using a blood test
Time Frame
twelve-months follow-up in experimental and control groups
Title
Glucose
Description
Glucose measurement will be quantified mg/dL using a blood test
Time Frame
Baseline in experimental and control groups
Title
Glucose
Description
Glucose measurement will be quantified mg/dL using a blood test
Time Frame
twelve-months follow-up in experimental and control groups
Title
Alanine aminotransferase
Description
Alanine aminotransferase measurement will be quantified U/L using a blood test
Time Frame
Baseline in experimental and control groups
Title
Alanine aminotransferase
Description
Alanine aminotransferase measurement will be quantified U/L using a blood test
Time Frame
twelve-months follow-up in experimental and control groups
Title
Glycated haemoglobin
Description
Glycated haemoglobin measurement will be quantified in percentage (%) using a blood test
Time Frame
Baseline in experimental and control groups
Title
Glycated haemoglobin
Description
Glycated haemoglobin measurement will be quantified in percentage (%) using a blood test
Time Frame
twelve-months follow-up in experimental and control groups
Title
General Anxiety Disorder
Description
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
Time Frame
Baseline in experimental and control groups
Title
General Anxiety Disorder
Description
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
Time Frame
twelve-months follow-up in experimental and control groups
Title
Patient Health Questionnaire
Description
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.
Time Frame
Baseline in experimental and control groups
Title
Patient Health Questionnaire
Description
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.
Time Frame
twelve-months follow-up in experimental and control groups
Title
The diastolic blood pressure (DBP) and the systolic blood pressure (SBP)
Description
In order to evaluate the vital signs we will use a vascular screening system, in the version VaSera VS-1500.
Time Frame
Baseline in experimental and control groups
Title
The diastolic blood pressure (DBP) and the systolic blood pressure (SBP)
Description
In order to evaluate the vital signs we will use a vascular screening system, in the version VaSera VS-1500.
Time Frame
twelve-months follow-up in experimental and control groups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier García-Campayo, PhD
Organizational Affiliation
Miguel Servet Hospital and University of Zaragoza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry. Miguel Servet University Hospital
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
http://doi.org/10.3886/E111741V1
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Learn more about this trial
Efficacy of a Mindful-eating Program to Reduce Emotional Eating
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