Efficacy of a Mindful-eating Program to Reduce Emotional Eating
- Conditions
- Overweight and Obesity
- Interventions
- Behavioral: Mindful Eating
- Registration Number
- NCT03927534
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Mindful Eating 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.
- Primary Outcome Measures
Name Time Method The Dutch Eating Behavior Questionnaire twelve-months follow-up in experimental and control groups It was designed to measure eating styles that may attenuate or contribute to the development of overweight. It comprises three scales that measure emotional, external and restrained eating. The Spanish version of the DEBQ has 33 items, 13 of them referred to the emotional eating scale (e.g., "Desire to eat when irritated"), and 10 items referring to the external (e.g., "Eating when you feel lonely") and restrictive (e.g., "Difficult to resist delicious food") scales, respectively. The items can be rated on a five-point likert scale with 1 indicating "never" and 5 indicating "very often".
- Secondary Outcome Measures
Name Time Method Sociodemographic data Gender, age, marital status, education, occupation, economical level Baseline in experimental and control groups Five Facet Mindfulness Questionnaire twelve-months follow-up in experimental and control groups The FFMQ-short form is a 24-item questionnaire that measures five aspects of mindfulness and there is a Spanish version based on it with appropriate psychometrics. The five facets the FFMQ measures are: observing (α = 81), describing (α = .87), acting with awareness (5 items, α = .83), non-judging to (5 items, α = .83) and non-reacting of (5 items, α = .75) inner experience. The participants indicate on a 5-point Likert scale the degree in which each item is generally true for them, ranging from 1 ("never or very rarely true") to 5 ("very often or always true").
Self-Compassion Scale twelve-months follow-up in experimental and control groups It is the most used self-report instrument to measure self-compassion and it is divided into six subscales: Self-Kindness; Self-Judgment; Common Humanity; Isolation; Mindfulness; and Over-Identification. The items can be rated on a five-point Likert-type scale with 1 indicating "almost never" and 5 indicating "almost always". After reversing the negatively formulated items, a total score can be calculated, which may range from 24 to 120, with higher scores indicating greater self-compassion
Mindful Eating Scale twelve-months follow-up in experimental and control groups The MES scale has 28 items, including six factors: acceptance (α = .89), awareness (α = .82), non-reactivity (α = .77), act with awareness (α = .81), routine (α = .75) and unstructured eating (α = .60). Items can be rated on a 4-point Likert-type scale, with 1 indicating "never" and 4 indicating "very often".
Bulimic Investigatory Test twelve-months follow-up in experimental and control groups The BITE is very used to measure the presence and severity of bulimic symptoms in nonclinical samples. Normative values for BITE total and sub-scale scores in clinical and non-clinical samples are reported. The scale includes in the Symptoms subscale (30 yes-no items; range =0-30) and Severity subscale (6 dimensional items addressing specific bulimic behaviors; range=0-39). In addition to these standars scores, another measure was derived from the BITE-the reported frequency of bingeing
Eating Attitude test (EAT-26) twelve-months follow-up in experimental and control groups The EAT-26 had three subscales Dieting, Bulimia and Food Preocupation, and Oral Control. It is and abbreviated version of the original EAT-40, having an excellent correlation. In the EAT-26 each item is answered on a 6-point Lickert scale and if the scoring is 20 or higher the patient should look for professional advice. The Eat-26 had an elevated reliability
Weight twelve-months follow-up in experimental and control groups Weight measurement will be quantified in kilograms using a digital scale
HDL twelve-months follow-up in experimental and control groups HDL measurement will be quantified mg/dL using a blood test
Glucose twelve-months follow-up in experimental and control groups Glucose measurement will be quantified mg/dL using a blood test
Alanine aminotransferase twelve-months follow-up in experimental and control groups Alanine aminotransferase measurement will be quantified U/L using a blood test
Patient Health Questionnaire twelve-months follow-up in experimental and control groups This scale is one of the most widely used questionnaires that assess the intensity of depression in pharmacological and psychological studies, it is useful to monitor changes experienced by patients over time. Through items like "Little interest or pleasure in doing things" and using a Liker-type scale from 0 ("not at all") to 3 ("nearly every day"), the PHQ-9 reflects the experience of participants during the last two weeks.
The diastolic blood pressure (DBP) and the systolic blood pressure (SBP) 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.
Abdominal perimeter twelve-months follow-up in experimental and control groups Abdominal perimeter measurement will be quantified in centimetres using a measuring tape
Height twelve-months follow-up in experimental and control groups Height measurement will be quantified in centimetres using a measuring tape
Cholesterol total twelve-months follow-up in experimental and control groups Cholesterol total measurement will be quantified mg/dL using a blood test
LDL twelve-months follow-up in experimental and control groups LDL measurement will be quantified mg/dL using a blood test
Glycated haemoglobin twelve-months follow-up in experimental and control groups Glycated haemoglobin measurement will be quantified in percentage (%) using a blood test
General Anxiety Disorder 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
Trial Locations
- Locations (1)
Department of Psychiatry. Miguel Servet University Hospital
🇪🇸Zaragoza, Spain