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Obesity and Mindful Eating in Patients With Anxiety (OMETA)

Primary Purpose

Anxiety, Obesity, Eating Behavior

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Mindful Eating
Video Group
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Anxiety, Obesity, Eating Behavior, Mindfulness

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Be between 18 and 50 years old; Inclusion for Generalized Anxiety Disorder (GAD): Primary GAD diagnosed by the M.I.N.I.; ✔Inclusion for Obesity: Obesity BMI grade I (between 30.0 and 34.9); Obesity BMI grade II (between 35.0 and 39.9) Exclusion Criteria: In individuals with obesity or control only, not having any psychiatric disorder; In individuals with only GAD or control, do not have a BMI above 25. In individuals with GAD, not having a diagnosis of primary or severe depression; Being under psychopharmacological, psychotherapeutic or nutritional treatment; Bipolar Disorder, Psychotic Disorder, Substance Use Disorder (except Tobacco) in the last 6 months or Suicidal Ideation in the last 6 months (M.I.N.I); Have a clinical instability or immobility; Being in Pregnancy or Lactation; Antisocial Personality Disorder; Eating Disorder.

Sites / Locations

  • Hospital de Clínicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindful Eating Group

Video Group

Arm Description

Mindful Eating practices will be taught during a weekly meeting lasting 150 minutes and individuals will be encouraged to integrate the practices learned into their daily lives, for at least 15 minutes a day, being progressively integrated into the other practices that will be taught in subsequent weeks. There will be a WhatsApp group with reminders during the week and audio for guided practice.

Composed of 5 videos sent weekly produced by trained professionals. The topics discussed will be relevant to the management of anxiety in general and lifestyle changes. Video 1: Psychoeducation of anxiety. Video 2: Healthy eating. Video 3: Sleep hygiene. Video 4: Physical activity. Video 5: Substance use. This protocol used as a control was effective as a Psychoeducation Group in improving anxiety symptoms in patients with generalized anxiety disorder.

Outcomes

Primary Outcome Measures

Change in Inhibitory Control
To evaluate the effectiveness of the Mindful Eating (ME) intervention in the performance in Go/No-go task compared to the control group with exposure to videos. This paradigm consists of the presentation of neutral images and food images on a computer screen (presented randomly, with a millisecond interval between them) and the participant must press or not press a key according to the researcher's instructions. The participant will be instructed to press the specific "Go" key when certain neutral images are viewed (office objects and bathroom objects). When food images and another class of neutral images (sports objects) are viewed, the participant will be instructed not to press any key and just wait (No Go). The "Go/No Go" paradigm, which has high reliability and replicability, makes it possible to evaluate inhibitory control, considering the commissioned number of errors in the No Go outcome.

Secondary Outcome Measures

Change in Inflammatory Markers
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Protein C-reactive and Interleukine-6 compared to the control group with exposure to videos.
Change in Emotional Regulation
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Difficulties in Emotion Regulation Scale (DERS) compared to the control group with exposure to videos. It is an instrument that assesses levels of emotional dysregulation in six domains. Contains 36 items on a 5-point Likert scale from 1 to 5.
Change in Self-Compassion
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Self-Compassion Scale (SCS) compared to the control group with exposure to videos. The self-compassion scale was designed to measure self-compassion in three components: self-judgment versus self-kindness (SJ-SK), sense of isolation versus common humanity (I-CH), over-identification versus mindfulness (OI-M). Respondents must rate how they usually behave in difficult times, according to a scale with 26 5-point items. Therefore, the higher the total SCS score, the more self-compassionate the individual.
Change in Impulsivity
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Barratt Impulsiveness Scale (BIS-11) compared to the control group with exposure to videos. The self-report scale developed by Barratt to assess these dimensions of impulsivity is composed of 20 questions for Inhibitory Control and 8 for Lack of Planning. The higher the score, the greater the level of impulsiveness.
Change in Emotional Eating
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Factor Eating Questionnaire (TFEQ-R21) compared to the control group with exposure to videos. This questionnaire is a self-administered instrument that assesses cognitive restriction behaviors (six questions), emotional eating (six questions) and uncontrolled eating (nine questions) and has good internal consistency. It has a total of 21 questions in which individuals rate the statement as true or false on a four-point scale, with "1" being completely true and "4" being completely false.
Change in Binge Eating
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Binge Eating Scale (BES) compared to the control group with exposure to videos. The BES is a self-administered Likert questionnaire, consisting of a list of 16 items and 62 statements, from which the one that best represents the individual's response must be selected for each item. Each statement corresponds to a number of points from 0 to 3, ranging from absence ("0") to maximum severity ("3") of binge eating.
Change in Body Appreciation
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Body Appreciation Scale (BAS) compared to the control group with exposure to videos. The BAS is a 13-item questionnaire designed to assess the degree of body appreciation. Items are rated on a five-point scale ranging from one (never) to five (always). Higher scores reflect greater body appreciation.
Change in Parental Bonding
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of The Parental Bonding Instrument (PBI) compared to the control group with exposure to videos.It is used to measure parental behavior as perceived by the offspring. The instrument consists of 25 items: 12 'care' items and 13 'protection' items. Raters are asked to rate the parents' behavior as they remember it in the first 16 years of their lives. For mothers, the cut-off point between the high and low scores is 27.0 and for the protection score it is 13.5. For parents, a care score of 24.0 and a protection score of 12.5.
Change in Early Memories
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Early Memories of Warmth and Safeness Scale (EMWSS) compared to the control group with exposure to videos. The EMWSS is a measure that assesses emotional memories of being protected, loved and cared for by adults. The scale assesses recall of positive feelings particularly of safety, warmth and care during childhood. It is a 21-item Likert-type scale (from 0=never to 4=Yes, most of the time).
Change in Early Life Experiences
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of The Early Life Experiences Scale (ELES) compared to the control group with exposure to videos. This scale was designed to measure recall of perceived threat and subordination in childhood. The scale, therefore, is composed of 15 items focused on recalling the perceived threat (six items) and feeling subordinate and acting submissively (nine items). The response measure consists of a Likert-type scale assessing how often and how true each statement was for them in their childhood.
Change in Experiences in Close Relationships
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Experiences in Close Relationships - Relationship Structures Questionnaire (ECR-RS) compared to the control group with exposure to videos. The ECR-RS evaluates the bonding styles established in relationships with close people: father, mother, partner and friend. Each relationship is rated on a scale that theoretically comprises two factors: anxious and avoidant attachment. The total score for each subscale is the average of the items and ranges from 1 to 7, with higher scores indicating greater avoidant or anxious attachment.
Change in Weight Bias Internalization
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Weight Bias Internalization Scale (WBIS) compared to the control group with exposure to videos. The scale score ranges from 11 to 77 points, with items 1 and 9 evaluated with reverse scoring. The WBIS is self-administered and has no cutoff point, however, higher scores indicate greater internalization of weight stigma.
Change in BMI
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Body Mass Index (BMI) compared to the control group with exposure to videos.
Change in Body Fat - Bioimpedance index
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of body fat percentage compared to the control group with exposure to videos.
Change in Insulin resistance
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of HOMA index compared to the control group with exposure to videos. The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function and insulin sensitivity, as percentages of a normal reference population.

Full Information

First Posted
August 29, 2023
Last Updated
October 13, 2023
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Health Science of Porto Alegre, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT06087185
Brief Title
Obesity and Mindful Eating in Patients With Anxiety
Acronym
OMETA
Official Title
Evaluation of the Effect of Mindful Eating in Patients With Anxiety and Obesity.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Health Science of Porto Alegre, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico

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
Background: Obesity is chronic disease with high prevalence rates, functional disability and difficult long-term management. Anxiety is one of the most common psychological disorders in obesity, and when associated with other factors such as emotional eating and emotional dysregulation, it impairs treatment and interferes with lifestyle changes. Finding an intervention that improves the eating behavior of these patients and facilitates adherence to obesity treatment, associated with less emotional distress, is of great clinical interest. Objective: The aim of this study is to evaluate the effectiveness of the Mindful Eating (ME) intervention on neurocognitive and behavioral outcomes in patients with obesity and anxiety compared to the control group with exposure to videos promoting quality of life. Methods: A five-weeks randomized clinical trial will be performed with 52 patients in adulthood. The Mindful Eating intervention group will receive an online protocol with one meeting per week. This is a protocol that has been adapted for five weeks and consists of a group intervention with 10-15 participants. Mindfulness, Mindful Eating and Self-Compassion training will be based on the Eat for Life protocol. The control group will receive five videos of psychoeducation, one topic per week. After, all participants will receive lifestyle advices, a first-line "treatment-as-usual" to obesity. There will be a face-to-face assessment with anthropometric, behavioral and biological measurements pre and post-intervention. The outcomes may help in understanding the mechanisms underlying the change in eating behavior, in order to direct new therapeutic strategies for the treatment of anxiety and obesity comorbidities.
Detailed Description
This study is the second phase of a cross-sectional study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Obesity, Eating Behavior, Mindfulness, Inflammation, Self-Control
Keywords
Anxiety, Obesity, Eating Behavior, Mindfulness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a Randomized Clinical Trial (RCT) comparing the effectiveness of the adapted Mindful Eating protocol to the control with exposure to videos promoting quality of life in adults with anxiety and obesity.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindful Eating Group
Arm Type
Experimental
Arm Description
Mindful Eating practices will be taught during a weekly meeting lasting 150 minutes and individuals will be encouraged to integrate the practices learned into their daily lives, for at least 15 minutes a day, being progressively integrated into the other practices that will be taught in subsequent weeks. There will be a WhatsApp group with reminders during the week and audio for guided practice.
Arm Title
Video Group
Arm Type
Active Comparator
Arm Description
Composed of 5 videos sent weekly produced by trained professionals. The topics discussed will be relevant to the management of anxiety in general and lifestyle changes. Video 1: Psychoeducation of anxiety. Video 2: Healthy eating. Video 3: Sleep hygiene. Video 4: Physical activity. Video 5: Substance use. This protocol used as a control was effective as a Psychoeducation Group in improving anxiety symptoms in patients with generalized anxiety disorder.
Intervention Type
Behavioral
Intervention Name(s)
Mindful Eating
Other Intervention Name(s)
Mindfulness, Eat for Life protocol
Intervention Description
Mindful Eating practices will be taught during a weekly meeting lasting 150 minutes and individuals will be encouraged to integrate the practices learned into their daily lives, for at least 15 minutes a day, being progressively integrated into the other practices that will be taught in subsequent weeks. There will be a WhatsApp group with reminders during the week and audio for guided practice.
Intervention Type
Behavioral
Intervention Name(s)
Video Group
Intervention Description
Composed of 5 videos sent weekly produced by trained professionals. The topics discussed will be relevant to the management of anxiety in general and lifestyle changes. Video 1: Psychoeducation of anxiety. Video 2: Healthy eating. Video 3: Sleep hygiene. Video 4: Physical activity. Video 5: Substance use. This protocol used as a control was effective as a Psychoeducation Group in improving anxiety symptoms in patients with generalized anxiety disorder.
Primary Outcome Measure Information:
Title
Change in Inhibitory Control
Description
To evaluate the effectiveness of the Mindful Eating (ME) intervention in the performance in Go/No-go task compared to the control group with exposure to videos. This paradigm consists of the presentation of neutral images and food images on a computer screen (presented randomly, with a millisecond interval between them) and the participant must press or not press a key according to the researcher's instructions. The participant will be instructed to press the specific "Go" key when certain neutral images are viewed (office objects and bathroom objects). When food images and another class of neutral images (sports objects) are viewed, the participant will be instructed not to press any key and just wait (No Go). The "Go/No Go" paradigm, which has high reliability and replicability, makes it possible to evaluate inhibitory control, considering the commissioned number of errors in the No Go outcome.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Change in Inflammatory Markers
Description
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Protein C-reactive and Interleukine-6 compared to the control group with exposure to videos.
Time Frame
5 weeks
Title
Change in Emotional Regulation
Description
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Difficulties in Emotion Regulation Scale (DERS) compared to the control group with exposure to videos. It is an instrument that assesses levels of emotional dysregulation in six domains. Contains 36 items on a 5-point Likert scale from 1 to 5.
Time Frame
5 weeks
Title
Change in Self-Compassion
Description
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Self-Compassion Scale (SCS) compared to the control group with exposure to videos. The self-compassion scale was designed to measure self-compassion in three components: self-judgment versus self-kindness (SJ-SK), sense of isolation versus common humanity (I-CH), over-identification versus mindfulness (OI-M). Respondents must rate how they usually behave in difficult times, according to a scale with 26 5-point items. Therefore, the higher the total SCS score, the more self-compassionate the individual.
Time Frame
5 weeks
Title
Change in Impulsivity
Description
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Barratt Impulsiveness Scale (BIS-11) compared to the control group with exposure to videos. The self-report scale developed by Barratt to assess these dimensions of impulsivity is composed of 20 questions for Inhibitory Control and 8 for Lack of Planning. The higher the score, the greater the level of impulsiveness.
Time Frame
5 weeks
Title
Change in Emotional Eating
Description
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Factor Eating Questionnaire (TFEQ-R21) compared to the control group with exposure to videos. This questionnaire is a self-administered instrument that assesses cognitive restriction behaviors (six questions), emotional eating (six questions) and uncontrolled eating (nine questions) and has good internal consistency. It has a total of 21 questions in which individuals rate the statement as true or false on a four-point scale, with "1" being completely true and "4" being completely false.
Time Frame
5 weeks
Title
Change in Binge Eating
Description
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Binge Eating Scale (BES) compared to the control group with exposure to videos. The BES is a self-administered Likert questionnaire, consisting of a list of 16 items and 62 statements, from which the one that best represents the individual's response must be selected for each item. Each statement corresponds to a number of points from 0 to 3, ranging from absence ("0") to maximum severity ("3") of binge eating.
Time Frame
5 weeks
Title
Change in Body Appreciation
Description
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Body Appreciation Scale (BAS) compared to the control group with exposure to videos. The BAS is a 13-item questionnaire designed to assess the degree of body appreciation. Items are rated on a five-point scale ranging from one (never) to five (always). Higher scores reflect greater body appreciation.
Time Frame
5 weeks
Title
Change in Parental Bonding
Description
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of The Parental Bonding Instrument (PBI) compared to the control group with exposure to videos.It is used to measure parental behavior as perceived by the offspring. The instrument consists of 25 items: 12 'care' items and 13 'protection' items. Raters are asked to rate the parents' behavior as they remember it in the first 16 years of their lives. For mothers, the cut-off point between the high and low scores is 27.0 and for the protection score it is 13.5. For parents, a care score of 24.0 and a protection score of 12.5.
Time Frame
5 weeks
Title
Change in Early Memories
Description
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Early Memories of Warmth and Safeness Scale (EMWSS) compared to the control group with exposure to videos. The EMWSS is a measure that assesses emotional memories of being protected, loved and cared for by adults. The scale assesses recall of positive feelings particularly of safety, warmth and care during childhood. It is a 21-item Likert-type scale (from 0=never to 4=Yes, most of the time).
Time Frame
5 weeks
Title
Change in Early Life Experiences
Description
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of The Early Life Experiences Scale (ELES) compared to the control group with exposure to videos. This scale was designed to measure recall of perceived threat and subordination in childhood. The scale, therefore, is composed of 15 items focused on recalling the perceived threat (six items) and feeling subordinate and acting submissively (nine items). The response measure consists of a Likert-type scale assessing how often and how true each statement was for them in their childhood.
Time Frame
5 weeks
Title
Change in Experiences in Close Relationships
Description
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Experiences in Close Relationships - Relationship Structures Questionnaire (ECR-RS) compared to the control group with exposure to videos. The ECR-RS evaluates the bonding styles established in relationships with close people: father, mother, partner and friend. Each relationship is rated on a scale that theoretically comprises two factors: anxious and avoidant attachment. The total score for each subscale is the average of the items and ranges from 1 to 7, with higher scores indicating greater avoidant or anxious attachment.
Time Frame
5 weeks
Title
Change in Weight Bias Internalization
Description
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Weight Bias Internalization Scale (WBIS) compared to the control group with exposure to videos. The scale score ranges from 11 to 77 points, with items 1 and 9 evaluated with reverse scoring. The WBIS is self-administered and has no cutoff point, however, higher scores indicate greater internalization of weight stigma.
Time Frame
5 weeks
Title
Change in BMI
Description
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of Body Mass Index (BMI) compared to the control group with exposure to videos.
Time Frame
5 weeks
Title
Change in Body Fat - Bioimpedance index
Description
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of body fat percentage compared to the control group with exposure to videos.
Time Frame
5 weeks
Title
Change in Insulin resistance
Description
To evaluate the effectiveness of the Mindful Eating (ME) intervention in levels of HOMA index compared to the control group with exposure to videos. The Homeostasis Model Assessment (HOMA) estimates steady state beta cell function and insulin sensitivity, as percentages of a normal reference population.
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be between 18 and 50 years old; Inclusion for Generalized Anxiety Disorder (GAD): Primary GAD diagnosed by the M.I.N.I.; ✔Inclusion for Obesity: Obesity BMI grade I (between 30.0 and 34.9); Obesity BMI grade II (between 35.0 and 39.9) Exclusion Criteria: In individuals with obesity or control only, not having any psychiatric disorder; In individuals with only GAD or control, do not have a BMI above 25. In individuals with GAD, not having a diagnosis of primary or severe depression; Being under psychopharmacological, psychotherapeutic or nutritional treatment; Bipolar Disorder, Psychotic Disorder, Substance Use Disorder (except Tobacco) in the last 6 months or Suicidal Ideation in the last 6 months (M.I.N.I); Have a clinical instability or immobility; Being in Pregnancy or Lactation; Antisocial Personality Disorder; Eating Disorder.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natasha KO Fonseca, MsC
Phone
5554991912372
Email
natashakof@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gisele G Manfro, PhD
Organizational Affiliation
Federal University of Health Science of Porto Alegre
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
OMETA project
Phone
5551991986747
Email
ometaprojeto@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://instagram.com/ometaprojeto?igshid=MzRlODBiNWFlZA==
Description
OMETA Instagram

Learn more about this trial

Obesity and Mindful Eating in Patients With Anxiety

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