Mindful Eating for Eating Behavior Individuals Overweight and Obesity

• Sponsor: Federal University of Health Science of Porto Alegre (Other)
• Overall Status: Completed
• CT.gov ID: NCT05845411
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.7
• Patients Per Site Per Month: 4.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity; Behavior, Eating; Feeding Patterns	Behavioral: Mindful Eating; Other: Standard dietary treatment	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Impact of a Nutritional Intervention Based on Mindful Eating on the Eating Behavior of Individuals Living With Overweight and Obesity
• Actual Study Start Date: Jul 7, 2021
• Actual Primary Completion Date: Jul 30, 2022
• Actual Study Completion Date: Jul 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in eating behavior [Four months]

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

Secondary Outcome Measures

1. Body weight [Four months]

   in kilos

2. Body Mass Index - BMI [Four months]

   in kg/m²

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Federal University of Health Sciences of Porto Alegre	Porto Alegre	Rio Grande Do Sul	Brazil	90050-170

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maria Fernanda Souza Moreira, RD, MSc, Federal University of Health Science of Porto Alegre
• ClinicalTrials.gov Identifier: NCT05845411
• Other Study ID Numbers: CAAE46133421100005345
• First Posted: May 6, 2023
• Last Update Posted: May 6, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Maria Fernanda Souza Moreira, RD, MSc, Federal University of Health Science of Porto Alegre: Mindfulness; Mindful Eating; Weight management
• Additional relevant MeSH terms: Obesity; Overweight

Study Results

No Results Posted as of May 6, 2023