Mindful Eating for Eating Behavior Individuals Overweight and Obesity

Impact of a Nutritional Intervention Based on Mindful Eating on the Eating Behavior of Individuals Living With Overweight and Obesity

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity; Feeding Patterns; Behavior, Eating
• Intervention / Treatment: Behavioral: Mindful Eating; Other: Standard dietary treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
      • Federal University of Health Sciences of Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	Other: Standard dietary treatment; Hypocaloric dietary prescription and nutritional education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in eating behavior	Sub-divided into domains: uncontrolled eating (UE), cognitive restriction (CR), and emotional eating (EE).	Four months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	in kilos	Four months
Body Mass Index - BMI	in kg/m²	Four months

Collaborators and Investigators

• Sponsor: Federal University of Health Science of Porto Alegre
• Investigators: Principal Investigator: Maria Fernanda Souza Moreira, MSc, Federal University of Health Sciences of Porto Alegre; Study Director: Fernanda Michielin Busnello, PhD, Federal University of Health Sciences of Porto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2021
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: April 26, 2023
• First Submitted That Met QC Criteria: April 26, 2023
• First Posted (Estimate): May 5, 2023

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Mindfulness; Mindful Eating; Weight management
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: CAAE46133421100005345

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No