NCT05845411

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
Last Updated

May 6, 2023

Status Verified

April 1, 2023

Enrollment Period

1.1 years

First QC Date

April 26, 2023

Last Update Submit

April 26, 2023

Conditions

Overweight and ObesityBehavior, EatingFeeding Patterns

Keywords

MindfulnessMindful EatingWeight management;

Outcome Measures

Primary Outcomes (1)

  • Change in eating behavior

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

    Four months

Secondary Outcomes (2)

  • Body weight

    Four months

  • Body Mass Index - BMI

    Four months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

Mindful EatingBEHAVIORAL

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

Intervention
Standard dietary treatmentOTHER

Hypocaloric dietary prescription and nutritional education.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • body mass index greater than or equal to 25 kg/m²,
  • internet access,
  • availability to participate in 8 virtual meetings.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 39771009DERIVED

MeSH Terms

Conditions

OverweightObesityFeeding Behavior

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Study Officials

  • Maria Fernanda Souza Moreira, MSc

    Federal University of Health Sciences of Porto Alegre

    PRINCIPAL INVESTIGATOR

  • Fernanda Michielin Busnello, PhD

    Federal University of Health Sciences of Porto Alegre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RD, MSc

Study Record Dates

First Submitted

April 26, 2023

First Posted

May 6, 2023

Study Start

July 7, 2021

Primary Completion

July 30, 2022

Study Completion

July 30, 2022

Last Updated

May 6, 2023

Record last verified: 2023-04

Locations

BR(1)