Efficacy of a Mindful-eating Program to Reduce Emotional Eating

Overweight and Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03927534
• Other study ID #: 05/2019
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: August 30, 2020

Study information

• Verified date: February 2021
• Source: Hospital Miguel Servet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: August 30, 2020
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

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.

Locations

Country	Name	City	State
Spain	Department of Psychiatry. Miguel Servet University Hospital	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Miguel Servet	Dharamsala Institute of Mindfulness and Psychotherapy of Zaragoza

Country where clinical trial is conducted

Spain, 

References & Publications (11)

Fanning J, Osborn CY, Lagotte AE, Mayberry LS. Relationships between dispositional mindfulness, health behaviors, and hemoglobin A1c among adults with type 2 diabetes. J Behav Med. 2018 Dec;41(6):798-805. doi: 10.1007/s10865-018-9938-3. Epub 2018 May 25. — View Citation

Godsey J. The role of mindfulness based interventions in the treatment of obesity and eating disorders: an integrative review. Complement Ther Med. 2013 Aug;21(4):430-9. doi: 10.1016/j.ctim.2013.06.003. Epub 2013 Jul 9. Review. — View Citation

Hölzel BK, Lazar SW, Gard T, Schuman-Olivier Z, Vago DR, Ott U. How Does Mindfulness Meditation Work? Proposing Mechanisms of Action From a Conceptual and Neural Perspective. Perspect Psychol Sci. 2011 Nov;6(6):537-59. doi: 10.1177/1745691611419671. — View Citation

Kristeller JL, Hallett CB. An Exploratory Study of a Meditation-based Intervention for Binge Eating Disorder. J Health Psychol. 1999 May;4(3):357-63. doi: 10.1177/135910539900400305. — View Citation

Mann T, Tomiyama AJ, Westling E, Lew AM, Samuels B, Chatman J. Medicare's search for effective obesity treatments: diets are not the answer. Am Psychol. 2007 Apr;62(3):220-33. Review. — View Citation

Mantzios M, Wilson JC. Mindfulness, Eating Behaviours, and Obesity: A Review and Reflection on Current Findings. Curr Obes Rep. 2015 Mar;4(1):141-6. doi: 10.1007/s13679-014-0131-x. Review. — View Citation

Mason AE, Epel ES, Kristeller J, Moran PJ, Dallman M, Lustig RH, Acree M, Bacchetti P, Laraia BA, Hecht FM, Daubenmier J. Effects of a mindfulness-based intervention on mindful eating, sweets consumption, and fasting glucose levels in obese adults: data from the SHINE randomized controlled trial. J Behav Med. 2016 Apr;39(2):201-13. doi: 10.1007/s10865-015-9692-8. Epub 2015 Nov 12. — View Citation

Medina WL, Wilson D, de Salvo V, Vannucchi B, de Souza ÉL, Lucena L, Sarto HM, Modrego-Alarcón M, Garcia-Campayo J, Demarzo M. Effects of Mindfulness on Diabetes Mellitus: Rationale and Overview. Curr Diabetes Rev. 2017;13(2):141-147. doi: 10.2174/1573399812666160607074817. Review. — View Citation

Miller CK, Kristeller JL, Headings A, Nagaraja H, Miser WF. Comparative effectiveness of a mindful eating intervention to a diabetes self-management intervention among adults with type 2 diabetes: a pilot study. J Acad Nutr Diet. 2012 Nov;112(11):1835-42. doi: 10.1016/j.jand.2012.07.036. — View Citation

Rosenzweig S, Reibel DK, Greeson JM, Edman JS, Jasser SA, McMearty KD, Goldstein BJ. Mindfulness-based stress reduction is associated with improved glycemic control in type 2 diabetes mellitus: a pilot study. Altern Ther Health Med. 2007 Sep-Oct;13(5):36-8. — View Citation

Rössner S. Obesity: the disease of the twenty-first century. Int J Obes Relat Metab Disord. 2002 Dec;26 Suppl 4:S2-4. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Dutch Eating Behavior Questionnaire	It was designed to measure eating styles that may attenuate or contribute to the development of overweight. It comprises three scales that measure emotional, external and restrained eating. The Spanish version of the DEBQ has 33 items, 13 of them referred to the emotional eating scale (e.g., "Desire to eat when irritated"), and 10 items referring to the external (e.g., "Eating when you feel lonely") and restrictive (e.g., "Difficult to resist delicious food") scales, respectively. The items can be rated on a five-point likert scale with 1 indicating "never" and 5 indicating "very often".	Baseline in experimental and control groups.
Primary	The Dutch Eating Behavior Questionnaire	It was designed to measure eating styles that may attenuate or contribute to the development of overweight. It comprises three scales that measure emotional, external and restrained eating. The Spanish version of the DEBQ has 33 items, 13 of them referred to the emotional eating scale (e.g., "Desire to eat when irritated"), and 10 items referring to the external (e.g., "Eating when you feel lonely") and restrictive (e.g., "Difficult to resist delicious food") scales, respectively. The items can be rated on a five-point likert scale with 1 indicating "never" and 5 indicating "very often".	Post-treatment 8 weeks from baseline in experimental and control groups
Primary	The Dutch Eating Behavior Questionnaire	It was designed to measure eating styles that may attenuate or contribute to the development of overweight. It comprises three scales that measure emotional, external and restrained eating. The Spanish version of the DEBQ has 33 items, 13 of them referred to the emotional eating scale (e.g., "Desire to eat when irritated"), and 10 items referring to the external (e.g., "Eating when you feel lonely") and restrictive (e.g., "Difficult to resist delicious food") scales, respectively. The items can be rated on a five-point likert scale with 1 indicating "never" and 5 indicating "very often".	twelve-months follow-up in experimental and control groups
Secondary	Sociodemographic data Gender, age, marital status, education, occupation, economical level		Baseline in experimental and control groups
Secondary	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 (a = 81), describing (a = .87), acting with awareness (5 items, a = .83), non-judging to (5 items, a = .83) and non-reacting of (5 items, a = .75) inner experience. The participants indicate on a 5-point Likert scale the degree in which each item is generally true for them, ranging from 1 ("never or very rarely true") to 5 ("very often or always true").	Baseline in experimental and control groups
Secondary	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 (a = 81), describing (a = .87), acting with awareness (5 items, a = .83), non-judging to (5 items, a = .83) and non-reacting of (5 items, a = .75) inner experience. The participants indicate on a 5-point Likert scale the degree in which each item is generally true for them, ranging from 1 ("never or very rarely true") to 5 ("very often or always true").	Post-treatment 8 weeks from baseline in experimental and control groups
Secondary	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 (a = 81), describing (a = .87), acting with awareness (5 items, a = .83), non-judging to (5 items, a = .83) and non-reacting of (5 items, a = .75) inner experience. The participants indicate on a 5-point Likert scale the degree in which each item is generally true for them, ranging from 1 ("never or very rarely true") to 5 ("very often or always true").	twelve-months follow-up in experimental and control groups
Secondary	Self-Compassion Scale	It is the most used self-report instrument to measure self-compassion and it is divided into six subscales: Self-Kindness; Self-Judgment; Common Humanity; Isolation; Mindfulness; and Over-Identification. The items can be rated on a five-point Likert-type scale with 1 indicating "almost never" and 5 indicating "almost always". After reversing the negatively formulated items, a total score can be calculated, which may range from 24 to 120, with higher scores indicating greater self-compassion	Baseline in experimental and control groups
Secondary	Self-Compassion Scale	It is the most used self-report instrument to measure self-compassion and it is divided into six subscales: Self-Kindness; Self-Judgment; Common Humanity; Isolation; Mindfulness; and Over-Identification. The items can be rated on a five-point Likert-type scale with 1 indicating "almost never" and 5 indicating "almost always". After reversing the negatively formulated items, a total score can be calculated, which may range from 24 to 120, with higher scores indicating greater self-compassion	Post-treatment 8 weeks from baseline in experimental and control groups
Secondary	Self-Compassion Scale	It is the most used self-report instrument to measure self-compassion and it is divided into six subscales: Self-Kindness; Self-Judgment; Common Humanity; Isolation; Mindfulness; and Over-Identification. The items can be rated on a five-point Likert-type scale with 1 indicating "almost never" and 5 indicating "almost always". After reversing the negatively formulated items, a total score can be calculated, which may range from 24 to 120, with higher scores indicating greater self-compassion	twelve-months follow-up in experimental and control groups
Secondary	Mindful Eating Scale	The MES scale has 28 items, including six factors: acceptance (a = .89), awareness (a = .82), non-reactivity (a = .77), act with awareness (a = .81), routine (a = .75) and unstructured eating (a = .60). Items can be rated on a 4-point Likert-type scale, with 1 indicating "never" and 4 indicating "very often".	Baseline in experimental and control groups
Secondary	Mindful Eating Scale	The MES scale has 28 items, including six factors: acceptance (a = .89), awareness (a = .82), non-reactivity (a = .77), act with awareness (a = .81), routine (a = .75) and unstructured eating (a = .60). Items can be rated on a 4-point Likert-type scale, with 1 indicating "never" and 4 indicating "very often".	Post-treatment 8 weeks from baseline in experimental and control groups
Secondary	Mindful Eating Scale	The MES scale has 28 items, including six factors: acceptance (a = .89), awareness (a = .82), non-reactivity (a = .77), act with awareness (a = .81), routine (a = .75) and unstructured eating (a = .60). Items can be rated on a 4-point Likert-type scale, with 1 indicating "never" and 4 indicating "very often".	twelve-months follow-up in experimental and control groups
Secondary	Bulimic Investigatory Test	The BITE is very used to measure the presence and severity of bulimic symptoms in nonclinical samples. Normative values for BITE total and sub-scale scores in clinical and non-clinical samples are reported. The scale includes in the Symptoms subscale (30 yes-no items; range =0-30) and Severity subscale (6 dimensional items addressing specific bulimic behaviors; range=0-39). In addition to these standars scores, another measure was derived from the BITE-the reported frequency of bingeing	Baseline in experimental and control groups
Secondary	Bulimic Investigatory Test	The BITE is very used to measure the presence and severity of bulimic symptoms in nonclinical samples. Normative values for BITE total and sub-scale scores in clinical and non-clinical samples are reported. The scale includes in the Symptoms subscale (30 yes-no items; range =0-30) and Severity subscale (6 dimensional items addressing specific bulimic behaviors; range=0-39). In addition to these standars scores, another measure was derived from the BITE-the reported frequency of bingeing	Post-treatment 8 weeks from baseline in experimental and control groups
Secondary	Bulimic Investigatory Test	The BITE is very used to measure the presence and severity of bulimic symptoms in nonclinical samples. Normative values for BITE total and sub-scale scores in clinical and non-clinical samples are reported. The scale includes in the Symptoms subscale (30 yes-no items; range =0-30) and Severity subscale (6 dimensional items addressing specific bulimic behaviors; range=0-39). In addition to these standars scores, another measure was derived from the BITE-the reported frequency of bingeing	twelve-months follow-up in experimental and control groups
Secondary	Eating Attitude test (EAT-26)	The EAT-26 had three subscales Dieting, Bulimia and Food Preocupation, and Oral Control. It is and abbreviated version of the original EAT-40, having an excellent correlation. In the EAT-26 each item is answered on a 6-point Lickert scale and if the scoring is 20 or higher the patient should look for professional advice. The Eat-26 had an elevated reliability	Baseline in experimental and control groups
Secondary	Eating Attitude test (EAT-26)	The EAT-26 had three subscales Dieting, Bulimia and Food Preocupation, and Oral Control. It is and abbreviated version of the original EAT-40, having an excellent correlation. In the EAT-26 each item is answered on a 6-point Lickert scale and if the scoring is 20 or higher the patient should look for professional advice. The Eat-26 had an elevated reliability	Post-treatment 8 weeks from baseline in experimental and control groups
Secondary	Eating Attitude test (EAT-26)	The EAT-26 had three subscales Dieting, Bulimia and Food Preocupation, and Oral Control. It is and abbreviated version of the original EAT-40, having an excellent correlation. In the EAT-26 each item is answered on a 6-point Lickert scale and if the scoring is 20 or higher the patient should look for professional advice. The Eat-26 had an elevated reliability	twelve-months follow-up in experimental and control groups
Secondary	Weight	Weight measurement will be quantified in kilograms using a digital scale	Baseline in experimental and control groups
Secondary	Weight	Weight measurement will be quantified in kilograms using a digital scale	twelve-months follow-up in experimental and control groups
Secondary	Abdominal perimeter	Abdominal perimeter measurement will be quantified in centimetres using a measuring tape	Baseline in experimental and control groupsw-up in experimental and control groups
Secondary	Abdominal perimeter	Abdominal perimeter measurement will be quantified in centimetres using a measuring tape	twelve-months follow-up in experimental and control groups
Secondary	Height	Height measurement will be quantified in centimetres using a measuring tape	Baseline in experimental and control groups
Secondary	Height	Height measurement will be quantified in centimetres using a measuring tape	twelve-months follow-up in experimental and control groups
Secondary	Cholesterol total	Cholesterol total measurement will be quantified mg/dL using a blood test	Baseline in experimental and control groups
Secondary	Cholesterol total	Cholesterol total measurement will be quantified mg/dL using a blood test	twelve-months follow-up in experimental and control groups
Secondary	LDL	LDL measurement will be quantified mg/dL using a blood test	Baseline in experimental and control groups
Secondary	LDL	LDL measurement will be quantified mg/dL using a blood test	twelve-months follow-up in experimental and control groups
Secondary	HDL	HDL measurement will be quantified mg/dL using a blood test	Baseline in experimental and control groups
Secondary	HDL	HDL measurement will be quantified mg/dL using a blood test	twelve-months follow-up in experimental and control groups
Secondary	Glucose	Glucose measurement will be quantified mg/dL using a blood test	Baseline in experimental and control groups
Secondary	Glucose	Glucose measurement will be quantified mg/dL using a blood test	twelve-months follow-up in experimental and control groups
Secondary	Alanine aminotransferase	Alanine aminotransferase measurement will be quantified U/L using a blood test	Baseline in experimental and control groups
Secondary	Alanine aminotransferase	Alanine aminotransferase measurement will be quantified U/L using a blood test	twelve-months follow-up in experimental and control groups
Secondary	Glycated haemoglobin	Glycated haemoglobin measurement will be quantified in percentage (%) using a blood test	Baseline in experimental and control groups
Secondary	Glycated haemoglobin	Glycated haemoglobin measurement will be quantified in percentage (%) using a blood test	twelve-months follow-up in experimental and control groups
Secondary	General Anxiety Disorder	It is one of the most frequently used diagnostic self-report scales for screening, diagnosis and anxiety disorder severity assessment, defined as an excessive anxiety and worry (apprehensive expectation) related to a number of events or activities, associated to experiencing difficulties to control that worry. Items are rated on a 4-point Likert-type scale (between 0 = "not at all" and 3 = "nearly every day"). The GAD-7 inquires about events happening over the last two weeks, in order to know how often the patient has been bothered by them	Baseline in experimental and control groups
Secondary	General Anxiety Disorder	It is one of the most frequently used diagnostic self-report scales for screening, diagnosis and anxiety disorder severity assessment, defined as an excessive anxiety and worry (apprehensive expectation) related to a number of events or activities, associated to experiencing difficulties to control that worry. Items are rated on a 4-point Likert-type scale (between 0 = "not at all" and 3 = "nearly every day"). The GAD-7 inquires about events happening over the last two weeks, in order to know how often the patient has been bothered by them	twelve-months follow-up in experimental and control groups
Secondary	Patient Health Questionnaire	This scale is one of the most widely used questionnaires that assess the intensity of depression in pharmacological and psychological studies, it is useful to monitor changes experienced by patients over time. Through items like "Little interest or pleasure in doing things" and using a Liker-type scale from 0 ("not at all") to 3 ("nearly every day"), the PHQ-9 reflects the experience of participants during the last two weeks.	Baseline in experimental and control groups
Secondary	Patient Health Questionnaire	This scale is one of the most widely used questionnaires that assess the intensity of depression in pharmacological and psychological studies, it is useful to monitor changes experienced by patients over time. Through items like "Little interest or pleasure in doing things" and using a Liker-type scale from 0 ("not at all") to 3 ("nearly every day"), the PHQ-9 reflects the experience of participants during the last two weeks.	twelve-months follow-up in experimental and control groups
Secondary	The diastolic blood pressure (DBP) and the systolic blood pressure (SBP)	In order to evaluate the vital signs we will use a vascular screening system, in the version VaSera VS-1500.	Baseline in experimental and control groups
Secondary	The diastolic blood pressure (DBP) and the systolic blood pressure (SBP)	In order to evaluate the vital signs we will use a vascular screening system, in the version VaSera VS-1500.	twelve-months follow-up in experimental and control groups