Eating DisordersNCT06230107
The Effects of Nutritional Intervention in Participants With Eating Disorders.
A study testing Mindful Eating in people with Eating Disorders and Binge-Eating Disorder, run by Sao Jose do Rio Preto Medical School at 1 site in Brazil.
Trial summary
The goal of this clinical trial is to evaluate the effects of nutritional intervention in eating disorders. Participants underwent an intervention without a control group over 8 weeks. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Eating Disorders, Binge-Eating Disorder, Binge Eating Disorder Associated With Obesity
- What is being tested?
- Mindful Eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteBrazil
- Study dates
- 18 Oct 2023to 15 Dec 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- individuals diagnosed with BED who are available to participate
Who cannot join
- individuals without a diagnosis of BED who are available to participate; who cannot attend meetings; with clinical changes; who have difficulty answering the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Therapeutic Intervention in Eating Disorders
The goal of this clinical trial is to evaluate the effects of nutritional intervention in eating disorders. Participants underwent an intervention without a control group over 8 weeks. This study aims to provide the maximization of nutritional rehabilitation and support changes in the construction of food autonomy, through a food and nutritional intervention.
Read the detailed description
Analyze the impact of nutritional intervention on changes in dietary habits, episodes of binge eating, body image dissatisfaction, quality of life and anthropometric data (weight, BMI and waist circumference) of participants with BED. This quantitative, prospective, longitudinal and experimental study recruited 82 participants diagnosed with Obesity and BED. The intervention was divided into 8 individual weekly meetings, guided by Mindful eating session, nutritional educational dynamics, cooking workshop, food sensory analysis and applications of questionnaires (Body Image Scale - BSQ; Binge Eating Scale - BES; Quality of Life Scale - WHOQOL BREF). The meetings occurred from October to November 2023.
- Conditions
- Eating Disorders, Binge-Eating Disorder, Binge Eating Disorder Associated With Obesity, Eating Behavior, Eating Disorder
- Being tested
- Mindful Eating
- Keywords
- eating disorders, binge eating disorder, eating behavior, eating disorder
- Medical subject headings
- Feeding and Eating Disorders, Binge-Eating Disorder, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful EatingBehavioural
Analyze the impact of Mindful Eating on changes in dietary habits, episodes of binge eating, body image dissatisfaction, quality of life and anthropometric data (weight, BMI and waist circumference) in Participants with obesity and BED.
| Study group | Role | What they receive |
|---|---|---|
| Participants diagnosed with Binge Eating Disorder | Experimental | The intervention was divided into 8 individual weekly meetings, guided by Mindful eating session, nutritional educational dynamics, cooking workshop, food sensory analysis and applications of questionnaires Receives: Behavioral: Mindful Eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episodes of Binge Eating {Binge Eating Scale (BES} (0 to 48 points)}.
Evaluate the impact of nutritional intervention on the variation in the number of binge eating episodes between the 1st and 8th week. Application of the 'Binge Eating Scale (BES) which quantifies the severity of Binge Eating, cognitions, feelings, and behaviors related to the Binge Eating episode, consisting of 16 items in a 4-point Likert format and 62 statements from which the one that best represents the individual's response. Each statement corresponds to a number of points from 0 to 3, ranging from the absence ("0") to the maximum severity ("3") of Binge Eating. The final score is the result of the sum of the points for each item. According to the classification, individuals with a score less than or equal to 17 are classified as "No Binge Eating". Individuals with a score between 18 and 26 are considered to have "Moderate Binge Eating" and those with a score greater than or equal to 27 are classified as "Severe Binge Eating" (minimum 0 points and maximum 48 points).
Measured: 8 weeks
Body Image Dissatisfaction {Body Shape Questionnaire (BSQ) (34 to 204 points)}.
Evaluate the impact of nutritional intervention on the level of body image dissatisfaction between the 1st and 8th week. Application of the Body Image Scale (BSQ) who was measures satisfaction and concern with body shape, consisting of 34 items on a 6-point Likert scale. According to the classification, to be classified as "satisfied with your body shape" is necessary score <111 (minimum 34 points and maximum 204 points).
Measured: 8 weeks
Quality of Life {Quality of LifeScale WHOQOL BREF) (0 to 100%)}.
Evaluate the impact of nutritional intervention on quality of life between the 1st and 8th week. Application of the Quality of Life Scale WHOQOL BREF who was evaluates the quality of life of the patient, comprising 26 Likert-scale questions. This ques-tionnaire is divided into 4 domains - physical, psychological, social, and environmental. According to the classification, the higher the percentage, the better the quality of life (0-100%)
Measured: 8 weeks
Weight (kg).
Evaluate the impact of nutritional intervention on weight (kg) between the 1st and 8th week.
Measured: 8 weeks
Body Mass Index (kg/m²).
Evaluate the impact of nutritional intervention on Body Mass Index [Weight(kg)/height(m)²] between the 1st and 8th week.
Measured: 8 weeks
Waist circumference (cm).
Evaluate the impact of nutritional intervention on waist circumference (cm) between the 1st and 8th week.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start18 Oct 2023
- Primary completion15 Nov 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- quantitative, prospective, longitudinal and experimental
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sao Jose do Rio Preto Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Tatiana Palotta Minari, Sao Jose do Rio Preto Medical School
- Investigators
- Tatiana Palotta Minari, PhD Student, Principal investigator, State Faculty of Medicine in São José do Rio Preto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230107
- Sponsor's protocol ID
- 70217317.4.0000.5415
- Status last verified
- Jan 2024
- First submitted
- 22 Dec 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in eating disorders. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Therapeutic Intervention in Eating Disorders
- ClinicalTrials.gov ID
- NCT06230107
- Acronym / sponsor ID
- 70217317.4.0000.5415
- Conditions
- Eating Disorders, Binge-Eating Disorder, Binge Eating Disorder Associated With Obesity, Eating Behavior, Eating Disorder
- Keywords
- eating disorders, binge eating disorder, eating behavior, eating disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Sao Jose do Rio Preto Medical SchoolUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 30 Jan 2024 (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.
The goal of this clinical trial is to evaluate the effects of nutritional intervention in eating disorders. Participants underwent an intervention without a control group over 8 weeks. This study aims to provide the maximization of nutritional rehabilitation and support changes in the construction of food autonomy, through a food and nutritional intervention.
Detailed description
Analyze the impact of nutritional intervention on changes in dietary habits, episodes of binge eating, body image dissatisfaction, quality of life and anthropometric data (weight, BMI and waist circumference) of participants with BED. This quantitative, prospective, longitudinal and experimental study recruited 82 participants diagnosed with Obesity and BED. The intervention was divided into 8 individual weekly meetings, guided by Mindful eating session, nutritional educational dynamics, cooking workshop, food sensory analysis and applications of questionnaires (Body Image Scale - BSQ; Binge Eating Scale - BES; Quality of Life Scale - WHOQOL BREF). The meetings occurred from October to November 2023.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- quantitative, prospective, longitudinal and experimental
| Arm | Type | Receives |
|---|---|---|
| Participants diagnosed with Binge Eating Disorder | Experimental | Behavioral: Mindful EatingThe intervention was divided into 8 individual weekly meetings, guided by Mindful eating session, nutritional educational dynamics, cooking workshop, food sensory analysis and applications of questionnaires |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- individuals diagnosed with BED who are available to participate
Key exclusion criteria (1 listed)
- individuals without a diagnosis of BED who are available to participate; who cannot attend meetings; with clinical changes; who have difficulty answering the questionnaires
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 EatingAnalyze the impact of Mindful Eating on changes in dietary habits, episodes of binge eating, body image dissatisfaction, quality of life and anthropometric data (weight, BMI and waist circumference) in Participants with obesity and BED. | Behavioural | Participants diagnosed with Binge Eating Disorder |
Primary outcome
Episodes of Binge Eating {Binge Eating Scale (BES} (0 to 48 points)}.
Time frame: 8 weeks
Evaluate the impact of nutritional intervention on the variation in the number of binge eating episodes between the 1st and 8th week. Application of the 'Binge Eating Scale (BES) which quantifies the severity of Binge Eating, cognitions, feelings, and behaviors related to the Binge Eating episode, consisting of 16 items in a 4-point Likert format and 62 statements from which the one that best represents the individual's response. Each statement corresponds to a number of points from 0 to 3, ranging from the absence ("0") to the maximum severity ("3") of Binge Eating. The final score is the result of the sum of the points for each item. According to the classification, individuals with a score less than or equal to 17 are classified as "No Binge Eating". Individuals with a score between 18 and 26 are considered to have "Moderate Binge Eating" and those with a score greater than or equal to 27 are classified as "Severe Binge Eating" (minimum 0 points and maximum 48 points).
Body Image Dissatisfaction {Body Shape Questionnaire (BSQ) (34 to 204 points)}.
Time frame: 8 weeks
Evaluate the impact of nutritional intervention on the level of body image dissatisfaction between the 1st and 8th week. Application of the Body Image Scale (BSQ) who was measures satisfaction and concern with body shape, consisting of 34 items on a 6-point Likert scale. According to the classification, to be classified as "satisfied with your body shape" is necessary score <111 (minimum 34 points and maximum 204 points).
Quality of Life {Quality of LifeScale WHOQOL BREF) (0 to 100%)}.
Time frame: 8 weeks
Evaluate the impact of nutritional intervention on quality of life between the 1st and 8th week. Application of the Quality of Life Scale WHOQOL BREF who was evaluates the quality of life of the patient, comprising 26 Likert-scale questions. This ques-tionnaire is divided into 4 domains - physical, psychological, social, and environmental. According to the classification, the higher the percentage, the better the quality of life (0-100%)
Weight (kg).
Time frame: 8 weeks
Evaluate the impact of nutritional intervention on weight (kg) between the 1st and 8th week.
Body Mass Index (kg/m²).
Time frame: 8 weeks
Evaluate the impact of nutritional intervention on Body Mass Index [Weight(kg)/height(m)²] between the 1st and 8th week.
Waist circumference (cm).
Time frame: 8 weeks
Evaluate the impact of nutritional intervention on waist circumference (cm) between the 1st and 8th week.
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 31 Jan 2024.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in eating disorders. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
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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.
Tatiana Palotta Minari, PhD Student principal investigator
State Faculty of Medicine in São José do Rio Preto
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 in people with Eating Disorders and Binge-Eating Disorder, run by Sao Jose do Rio Preto Medical School 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 1 inclusion and 1 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 31 Jan 2024. 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?
Episodes of Binge Eating {Binge Eating Scale (BES} (0 to 48 points)}. (time frame: 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2024.