Clinical trial NCT05845411: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Behavior, Eating
Feeding Patterns
Keywords: Mindfulness
Mindful Eating
Weight management;
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in eating behavior
timeFrame: Four months
Secondary outcomes:
measure: Body weight
timeFrame: Four months
measure: Body Mass Index - BMI
timeFrame: Four months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Health Sciences of Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Health Sciences of Porto Alegre
name: Maria Fernanda Souza Moreira, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Health Sciences of Porto Alegre
name: Fernanda Michielin Busnello, PhD
role: STUDY_DIRECTOR
References: