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Completed

NCT Number: NCT03927534

Efficacy of a Mindful-eating Program to Reduce Emotional Eating

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.

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry. Miguel Servet University Hospital

Zaragoza, 50009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindful Eating

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospital Miguel Servet

Other

Collaborators

  • Dharamsala Institute of Mindfulness and Psychotherapy of Zaragoza

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Apr 25, 2019
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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