Overweight and ObesityNCT05845411
Mindful Eating for Eating Behavior Individuals Overweight and Obesity
A study testing Mindful Eating and Standard dietary treatment in people with Overweight and Obesity and Behavior, Eating, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight and Obesity, Behavior, Eating, Feeding Patterns
- What is being tested?
- Mindful Eating and Standard dietary treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Jul 2021to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- body mass index greater than or equal to 25 kg/m²,
- internet access,
- availability to participate in 8 virtual meetings.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Health Sciences of Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight and Obesity, Behavior, Eating, Feeding Patterns
- Being tested
- Mindful Eating, Standard dietary treatment
- Keywords
- Mindfulness, Mindful Eating, Weight management;
- Medical subject headings
- Overweight, Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful EatingBehavioural
Nutritional advice through expository content, group discussion, and exchange of experiences on self-knowledge, food awareness, and relationship with food and the body.
Standard dietary treatmentOther
Hypocaloric dietary prescription and nutritional education.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard dietary treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in eating behavior
Sub-divided into domains: uncontrolled eating (UE), cognitive restriction (CR), and emotional eating (EE).
Measured: Four months
Secondary outcomes (2)
Body weight
in kilos
Measured: Four months
Body Mass Index - BMI
in kg/m²
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start7 Jul 2021
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Fernanda Souza Moreira, Federal University of Health Science of Porto Alegre
- Investigators
- Maria Fernanda Souza Moreira, MSc, Principal investigator, Federal University of Health Sciences of Porto AlegreFernanda Michielin Busnello, PhD, Study director, Federal University of Health Sciences of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845411
- Sponsor's protocol ID
- CAAE46133421100005345
- Status last verified
- Apr 2023
- First submitted
- 26 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39771009
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Nutritional Intervention Based on Mindful Eating on the Eating Behavior of Individuals Living With Overweight and Obesity
- ClinicalTrials.gov ID
- NCT05845411
- Acronym / sponsor ID
- CAAE46133421100005345
- Conditions
- Overweight and Obesity, Behavior, Eating, Feeding Patterns
- Keywords
- Mindfulness, Mindful Eating, Weight management;
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Mindful EatingA 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. |
| Control | Active comparator | Other: Standard dietary treatmentA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- body mass index greater than or equal to 25 kg/m²,
- internet access,
- availability to participate in 8 virtual meetings.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful EatingNutritional advice through expository content, group discussion, and exchange of experiences on self-knowledge, food awareness, and relationship with food and the body. | Behavioural | Intervention |
| Standard dietary treatmentHypocaloric dietary prescription and nutritional education. | Other | Control |
Primary outcome
Change in eating behavior
Time frame: Four months
Sub-divided into domains: uncontrolled eating (UE), cognitive restriction (CR), and emotional eating (EE).
2 secondary outcomes
Body weight
Time frame: Four months
Body Mass Index - BMI
Time frame: Four months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Derived from this study: PubMed 39771009Moreira 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Fernanda Souza Moreira, MSc principal investigator
Federal University of Health Sciences of Porto Alegre
Fernanda Michielin Busnello, PhD study director
Federal University of Health Sciences of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Eating and Standard dietary treatment in people with Overweight and Obesity and Behavior, Eating, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in eating behavior (time frame: Four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05845411, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.