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Mindful Eating for Eating Behavior Individuals Overweight and Obesity

Primary Purpose

Overweight and Obesity, Behavior, Eating, Feeding Patterns

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Mindful Eating
Standard dietary treatment
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Overweight and Obesity focused on measuring Mindfulness, Mindful Eating, Weight management;

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: body mass index greater than or equal to 25 kg/m², internet access, availability to participate in 8 virtual meetings. Exclusion Criteria: volunteers using pharmacotherapy for obesity, pregnancy, lactation, cognitive conditions, self-reported neurological or psychiatric disorders that prevent participation in the study, decompensated thyroid disorders, and who have undergone bariatric surgery.

Sites / Locations

  • Federal University of Health Sciences of Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

A group of 30 people will participate in 8 fortnightly virtual group sessions for 4 months, where the subject of Mindful Eating will be addressed. Participants will be encouraged to share their eating experiences, reflect and discuss the above, and engage in formal and non-formal mindfulness eating practices (meditation, eating slowly, observing thoughts, and being present at meal times) between sessions.

A group of 30 people will have 8 fortnightly, virtual, and individual consultations for 4 months. They will receive a hypocaloric diet (reduction of approximately 500kcal per day in total energy expenditure) and food and nutrition education. The food plan will be monitored in each meeting, and a theme of food and nutrition education will be worked on, based on the Food Guide for the Brazilian Population, through expository content. A virtual folder of all subjects taught will be provided.

Outcomes

Primary Outcome Measures

Change in eating behavior
Sub-divided into domains: uncontrolled eating (UE), cognitive restriction (CR), and emotional eating (EE).

Secondary Outcome Measures

Body weight
in kilos
Body Mass Index - BMI
in kg/m²

Full Information

First Posted
April 26, 2023
Last Updated
April 26, 2023
Sponsor
Federal University of Health Science of Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT05845411
Brief Title
Mindful Eating for Eating Behavior Individuals Overweight and Obesity
Official Title
Impact of a Nutritional Intervention Based on Mindful Eating on the Eating Behavior of Individuals Living With Overweight and Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This clinical trial aims to compare the effect of a nutritional intervention based on Mindful Eating, with standard dietary treatment, in changing the eating behavior of overweight individuals.
Detailed Description
This clinical trial aims to compare the effect of a nutritional intervention based on Mindful Eating, with standard dietary treatment, in changing the eating behavior of overweight individuals. The main questions to answer are: What is the effect of the intervention on the domains of eating behavior (emotional eating, cognitive restriction, and lack of food control - assessed by the Three-Factor Eating Questionnaire R21)? , Assess the effect of the intervention on weight and BMI. Evaluate the relationship between eating behavior domains before and after the intervention. Participants in the intervention group will participate in eight sessions of a virtual therapeutic group, with up to fifteen individuals, every fifteen days, in which the theme of Mindful Eating and eating behavior will be worked. Participants will be encouraged to undertake the following: self-knowledge exercises between one session and another. mindfulness meditations daily. No dietary plan will be provided. The researchers will compare the results with a control group, which will receive eight individual, fortnightly, and virtual consultations of conventional dietary treatment, which will provide: dietary plan for weight reduction, according to current guidelines. six food and nutrition education sessions based on the Food Guide for the Brazilian Population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Behavior, Eating, Feeding Patterns
Keywords
Mindfulness, Mindful Eating, Weight management;

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
A group of 30 people will participate in 8 fortnightly virtual group sessions for 4 months, where the subject of Mindful Eating will be addressed. Participants will be encouraged to share their eating experiences, reflect and discuss the above, and engage in formal and non-formal mindfulness eating practices (meditation, eating slowly, observing thoughts, and being present at meal times) between sessions.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
A group of 30 people will have 8 fortnightly, virtual, and individual consultations for 4 months. They will receive a hypocaloric diet (reduction of approximately 500kcal per day in total energy expenditure) and food and nutrition education. The food plan will be monitored in each meeting, and a theme of food and nutrition education will be worked on, based on the Food Guide for the Brazilian Population, through expository content. A virtual folder of all subjects taught will be provided.
Intervention Type
Behavioral
Intervention Name(s)
Mindful Eating
Intervention Description
Nutritional advice through expository content, group discussion, and exchange of experiences on self-knowledge, food awareness, and relationship with food and the body.
Intervention Type
Other
Intervention Name(s)
Standard dietary treatment
Intervention Description
Hypocaloric dietary prescription and nutritional education.
Primary Outcome Measure Information:
Title
Change in eating behavior
Description
Sub-divided into domains: uncontrolled eating (UE), cognitive restriction (CR), and emotional eating (EE).
Time Frame
Four months
Secondary Outcome Measure Information:
Title
Body weight
Description
in kilos
Time Frame
Four months
Title
Body Mass Index - BMI
Description
in kg/m²
Time Frame
Four months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: body mass index greater than or equal to 25 kg/m², internet access, availability to participate in 8 virtual meetings. Exclusion Criteria: volunteers using pharmacotherapy for obesity, pregnancy, lactation, cognitive conditions, self-reported neurological or psychiatric disorders that prevent participation in the study, decompensated thyroid disorders, and who have undergone bariatric surgery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Fernanda Souza Moreira, MSc
Organizational Affiliation
Federal University of Health Sciences of Porto Alegre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fernanda Michielin Busnello, PhD
Organizational Affiliation
Federal University of Health Sciences of Porto Alegre
Official's Role
Study Director
Facility Information:
Facility Name
Federal University of Health Sciences of Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90050-170
Country
Brazil

12. IPD Sharing Statement

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Mindful Eating for Eating Behavior Individuals Overweight and Obesity

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