Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of a Mindful-eating Program to Reduce Emotional Eating

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927534
Recruitment Status : Active, not recruiting
First Posted : April 25, 2019
Last Update Posted : November 13, 2019
Sponsor:
Collaborator:
Dharamsala Institute of Mindfulness and Psychotherapy of Zaragoza
Information provided by (Responsible Party):
Javier Garcia Campayo, Hospital Miguel Servet

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 Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : August 31, 2019
Estimated Study Completion Date : August 30, 2020

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.



Primary Outcome Measures :
  1. The Dutch Eating Behavior Questionnaire [ Time Frame: 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".

  2. The Dutch Eating Behavior Questionnaire [ Time Frame: 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".

  3. The Dutch Eating Behavior Questionnaire [ Time Frame: 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 :
  1. Sociodemographic data Gender, age, marital status, education, occupation, economical level [ Time Frame: Baseline in experimental and control groups ]
  2. Five Facet Mindfulness Questionnaire [ Time Frame: 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").

  3. Five Facet Mindfulness Questionnaire [ Time Frame: 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").

  4. Five Facet Mindfulness Questionnaire [ Time Frame: 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").

  5. Self-Compassion Scale [ Time Frame: 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

  6. Self-Compassion Scale [ Time Frame: 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

  7. Self-Compassion Scale [ Time Frame: 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

  8. Mindful Eating Scale [ Time Frame: 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".

  9. Mindful Eating Scale [ Time Frame: 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".

  10. Mindful Eating Scale [ Time Frame: 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".

  11. Bulimic Investigatory Test [ Time Frame: 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

  12. Bulimic Investigatory Test [ Time Frame: 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

  13. Bulimic Investigatory Test [ Time Frame: 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

  14. Eating Attitude test (EAT-26) [ Time Frame: 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

  15. Eating Attitude test (EAT-26) [ Time Frame: 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

  16. Eating Attitude test (EAT-26) [ Time Frame: 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

  17. Weight [ Time Frame: Baseline in experimental and control groups ]
    Weight measurement will be quantified in kilograms using a digital scale

  18. Weight [ Time Frame: twelve-months follow-up in experimental and control groups ]
    Weight measurement will be quantified in kilograms using a digital scale

  19. Abdominal perimeter [ Time Frame: Baseline in experimental and control groupsw-up in experimental and control groups ]
    Abdominal perimeter measurement will be quantified in centimetres using a measuring tape

  20. Abdominal perimeter [ Time Frame: twelve-months follow-up in experimental and control groups ]
    Abdominal perimeter measurement will be quantified in centimetres using a measuring tape

  21. Height [ Time Frame: Baseline in experimental and control groups ]
    Height measurement will be quantified in centimetres using a measuring tape

  22. Height [ Time Frame: twelve-months follow-up in experimental and control groups ]
    Height measurement will be quantified in centimetres using a measuring tape

  23. Cholesterol total [ Time Frame: Baseline in experimental and control groups ]
    Cholesterol total measurement will be quantified mg/dL using a blood test

  24. Cholesterol total [ Time Frame: twelve-months follow-up in experimental and control groups ]
    Cholesterol total measurement will be quantified mg/dL using a blood test

  25. LDL [ Time Frame: Baseline in experimental and control groups ]
    LDL measurement will be quantified mg/dL using a blood test

  26. LDL [ Time Frame: twelve-months follow-up in experimental and control groups ]
    LDL measurement will be quantified mg/dL using a blood test

  27. HDL [ Time Frame: Baseline in experimental and control groups ]
    HDL measurement will be quantified mg/dL using a blood test

  28. HDL [ Time Frame: twelve-months follow-up in experimental and control groups ]
    HDL measurement will be quantified mg/dL using a blood test

  29. Glucose [ Time Frame: Baseline in experimental and control groups ]
    Glucose measurement will be quantified mg/dL using a blood test

  30. Glucose [ Time Frame: twelve-months follow-up in experimental and control groups ]
    Glucose measurement will be quantified mg/dL using a blood test

  31. Alanine aminotransferase [ Time Frame: Baseline in experimental and control groups ]
    Alanine aminotransferase measurement will be quantified U/L using a blood test

  32. Alanine aminotransferase [ Time Frame: twelve-months follow-up in experimental and control groups ]
    Alanine aminotransferase measurement will be quantified U/L using a blood test

  33. Glycated haemoglobin [ Time Frame: Baseline in experimental and control groups ]
    Glycated haemoglobin measurement will be quantified in percentage (%) using a blood test

  34. Glycated haemoglobin [ Time Frame: twelve-months follow-up in experimental and control groups ]
    Glycated haemoglobin measurement will be quantified in percentage (%) using a blood test

  35. General Anxiety Disorder [ Time Frame: 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

  36. General Anxiety Disorder [ Time Frame: 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

  37. Patient Health Questionnaire [ Time Frame: 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.

  38. Patient Health Questionnaire [ Time Frame: 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.

  39. The diastolic blood pressure (DBP) and the systolic blood pressure (SBP) [ Time Frame: 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.

  40. The diastolic blood pressure (DBP) and the systolic blood pressure (SBP) [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927534


Locations
Layout table for location information
Spain
Department of Psychiatry. Miguel Servet University Hospital
Zaragoza, Spain, 50009
Sponsors and Collaborators
Hospital Miguel Servet
Dharamsala Institute of Mindfulness and Psychotherapy of Zaragoza
Investigators
Layout table for investigator information
Principal Investigator: Javier García-Campayo, PhD Miguel Servet Hospital and University of Zaragoza
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Javier Garcia Campayo, Principal Investigator, Hospital Miguel Servet
ClinicalTrials.gov Identifier: NCT03927534    
Other Study ID Numbers: 05/2019
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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).
Time Frame: Data will become available following each publication with no end date for replicating the results of the trial or for any analytical purpose
Access Criteria: Due to the clinical nature of the study and considering ethical concerns, the data (anonymised and completely de-identified) generated by this trial will be made available upon request to researchers a) who provide a methodologically sound proposal and b) whose proposed use of the data has been approved by an independent ethical review committee
URL: http://doi.org/10.3886/E111741V1

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Javier Garcia Campayo, Hospital Miguel Servet:
Obesity
Overweight
Mindful Eating
Primary Care
Randomized controlled trial (RCT)
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms