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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05845411
Other study ID # CAAE46133421100005345
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 7, 2021
Est. completion date July 30, 2022

Study information

Verified date April 2023
Source Federal University of Health Science of Porto Alegre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 30, 2022
Est. primary completion date July 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Behavioral:
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.
Other:
Standard dietary treatment
Hypocaloric dietary prescription and nutritional education.

Locations

Country Name City State
Brazil Federal University of Health Sciences of Porto Alegre Porto Alegre Rio Grande Do Sul

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in eating behavior Sub-divided into domains: uncontrolled eating (UE), cognitive restriction (CR), and emotional eating (EE). Four months
Secondary Body weight in kilos Four months
Secondary Body Mass Index - BMI in kg/m² Four months
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