Mindful Eating for Eating Behavior Individuals Overweight and Obesity

NCT ID: NCT05845411

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-07

Study Completion Date

2022-07-30

Brief Summary

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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

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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.

Conditions

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Overweight and Obesity Behavior, Eating Feeding Patterns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention

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.

Group Type EXPERIMENTAL

Mindful Eating

Intervention Type BEHAVIORAL

Nutritional advice through expository content, group discussion, and exchange of experiences on self-knowledge, food awareness, and relationship with food and the body.

Control

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.

Group Type ACTIVE_COMPARATOR

Standard dietary treatment

Intervention Type OTHER

Hypocaloric dietary prescription and nutritional education.

Interventions

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Mindful Eating

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 BEHAVIORAL

Standard dietary treatment

Hypocaloric dietary prescription and nutritional education.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Maria Fernanda Souza Moreira

RD, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Fernanda Souza Moreira, MSc

Role: PRINCIPAL_INVESTIGATOR

Federal University of Health Sciences of Porto Alegre

Fernanda Michielin Busnello, PhD

Role: STUDY_DIRECTOR

Federal University of Health Sciences of Porto Alegre

Locations

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Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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Moreira MFS, de Azevedo BEF, Beretta MV, Busnello FM. Nutritional Counseling Based on Mindful Eating for the Eating Behavior of People Living with Overweight and Obesity: A Randomized Clinical Trial. Nutrients. 2024 Dec 20;16(24):4388. doi: 10.3390/nu16244388.

Reference Type DERIVED
PMID: 39771009 (View on PubMed)

Other Identifiers

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CAAE46133421100005345

Identifier Type: -

Identifier Source: org_study_id

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