Mental HealthNCT07573410
Effects of Mindful Eating on Female Nutrition Students
A study testing "Eat for Life" Mindful Eating Program and Standard Nutritional Guidance in people with Mental Health and Body Image, run by Federal University of Uberlandia at 1 site in Brazil.
Trial summary
The goal of this pilot randomized clinical trial is to evaluate the efficacy of a mindful eating intervention ("Eat for Life") on eating behavior, body image, and mental health in female nutrition students. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Body Image, Feeding Behavior
- What is being tested?
- "Eat for Life" Mindful Eating Program and Standard Nutritional Guidance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female gender
- Active enrollment in the Nutrition undergraduate program at the time of data collection
- Agreement to participate in the study
Who cannot join
- Diagnosis of severe cognitive or mental disorders; Regular practice (at least once a week in the last six months) of meditation, yoga, or mindfulness
- Regular practice (at least once a week in the last six months) of meditation, yoga, or mindfulness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Universidade Federal de Uberlândia (UFU) - Campus Umuarama
Uberlândia, Minas Gerais (MG), 38405-318
Nilander P Nunes Filho, B.Sc.
About this study
Official title: Efficacy of a Mindful Eating Intervention on Eating Behavior, Body Image, and Mental Health in Female Nutrition Students: a Pilot Randomized Clinical Trial
The goal of this pilot randomized clinical trial is to evaluate the efficacy of a mindful eating intervention ("Eat for Life") on eating behavior, body image, and mental health in female nutrition students. The main questions it aims to answer are: Does a mindful eating intervention reduce disordered eating behaviors in female nutrition students? Does the intervention improve body appreciation, mindfulness levels, and mental health?
Researchers will compare an active control group receiving nutritional guidance to an intervention group participating in the "Eat for Life" mindful eating program to see if the mindful eating intervention reduces disordered eating behaviors and improves overall psychological well-being and body appreciation.
Read more
Participants will: Complete online questionnaires evaluating eating behavior, mindfulness, mental health, and body image at three distinct time points: before the intervention (baseline), post-intervention, and at a 3-month follow-up.
If assigned to the intervention group, attend 12 weekly face-to-face mindful eating sessions lasting approximately two hours each. If assigned to the active control group, receive weekly informative leaflets via WhatsApp with nutritional guidance based on the Dietary Guidelines for the Brazilian Population for 12 weeks
Read the detailed description
Female nutrition students are particularly vulnerable to disordered eating, mental health distress (such as anxiety and depression), and body image dissatisfaction due to intense academic and sociocultural pressures. The mindful eating protocol "Eat for Life" aims to address these issues by promoting mindfulness, emotional regulation, self-compassion, and body appreciation. Despite its potential, there is a lack of randomized clinical trials (RCTs) evaluating the efficacy of this specific protocol in this population.
This parallel-group, pilot randomized clinical trial aims to fill this gap, strictly adhering to the CONSORT (Consolidated Standards of Reporting Trials) guidelines. Participants will be allocated into two distinct groups using a computerized random number generator (www.randomizar.org).
Study Procedures and Data Management: Data collection will be conducted via online forms at three specific time points: baseline, 12 weeks (post-intervention), and a 3-month follow-up. To ensure rigorous data security and quality assurance in compliance with the Brazilian General Data Protection Law (LGPD), all collected data will be exported and stored securely in offline Excel spreadsheets. Only the core research team will have access to this information, and all records will be permanently destroyed after five years to guarantee confidentiality
Sample Size Assessment: The sample size was calculated using G*Power software. To detect a moderate effect size (f = 0.15) with a minimum statistical power of 80% and a 5% significance level across two groups and three measurement times, a minimum of 74 participants is required. Anticipating a potential 20% attrition rate (loss to follow-up), the final target sample size was established at 88 participants, meaning 44 individuals randomly distributed to each arm.
Statistical Analysis Plan: To minimize bias, all statistical analyses will be performed by an independent researcher blinded to the group allocations. The analyses will be conducted using STATA and R software. Descriptive statistics will be presented as means and standard deviations for continuous variables, and as absolute and relative frequencies for categorical data. Data normality will be assessed using the Shapiro-Wilk test. For comparisons between groups, parametric (Student's t-test) or non-parametric (Mann-Whitney test) tests will be applied based on the data distribution. Correlation analyses will utilize Pearson or Spearman tests, and all tests will adopt a significance level of 5% (p < 0.05). Methodological quality will also be evaluated using the CONSORT checklist.
.
- Conditions
- Mental Health, Body Image, Feeding Behavior, Feeding and Eating Disorders, Stress and Anxiety
- Being tested
- "Eat for Life" Mindful Eating Program, Standard Nutritional Guidance
- Keywords
- mindful eating, feeding behavior, Students, mental health
- Medical subject headings
- Psychological Well-Being, Feeding Behavior, Feeding and Eating Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Eat for Life" Mindful Eating ProgramBehavioural
A 12-week face-to-face mindful eating behavioral intervention. Participants will attend weekly sessions of approximately two hours led by a certified researcher. The program integrates formal mindfulness practices, group discussions, and reflections on personal values, self-compassion, body acceptance, and body appreciation to promote a conscious relationship with food, emotions, and the body.
Standard Nutritional GuidanceBehavioural
An active control intervention consisting of standard nutritional education. Participants will receive informative leaflets weekly via WhatsApp over a 12-week period. The content is based on the "Dietary Guidelines for the Brazilian Population" (Guia Alimentar para a População Brasileira), providing standard health and nutrition information without any mindfulness or mindful eating components.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Eat for Life Program | Experimental | Participants assigned to this arm will undergo the "Eat for Life" mindful eating program. This face-to-face intervention lasts for 12 weeks, with weekly sessions of approximately two hours conducted by a certified researcher. The protocol includes formal mindfulness practices, group discussions, and reflections on personal values, body acceptance, and body appreciation. Receives: Behavioral: "Eat for Life" Mindful Eating Program |
| Active Comparator: Nutritional Guidance | Active comparator | Participants assigned to this arm will receive standard nutritional guidance. Informational leaflets based on the Dietary Guidelines for the Brazilian Population will be sent weekly via WhatsApp over a concurrent 12-week period. Receives: Behavioral: Standard Nutritional Guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Disordered Eating Attitudes and Behaviors (EAT-26)
Assessed using the validated Brazilian Portuguese version of the Eating Attitudes Test (EAT-26). Each item is answered on a 6-point Likert scale, with total scores ranging from 0 to 78. Higher scores indicate greater severity of disordered eating attitudes and behaviors. A score of 21 or above indicates a positive screening for disordered eating (higher score = worse outcome).
Measured: Baseline (pre-intervention), Week 12 (immediately post-intervention), and 3 months post-intervention (follow-up).
Secondary outcomes (5)
Change in Intuitive Eating Behaviors (IES-2)
Assessed using the validated Brazilian Portuguese version of the Intuitive Eating Scale-2 (IES-2). The 23-item scale measures an individual's tendency to follow physical hunger and satiety cues rather than emotional cues, encompassing four factors. Items are rated on a 5-point Likert scale (1-5), with total scores ranging from 23 to 115. Higher scores indicate greater alignment with intuitive eating principles (higher score = better outcome).
Measured: Baseline (pre-intervention), Week 12 (immediately post-intervention), and 3 months post-intervention (follow-up)
Change in Mindfulness Levels (FFMQ)
Assessed using the validated Brazilian Portuguese version of the Five Facet Mindfulness Questionnaire (FFMQ-BR). The FFMQ-BR consists of 39 items structured into seven factors, all demonstrating good internal consistency. Items are rated on a 5-point Likert scale (1-5), with total scores ranging from 39 to 195. Higher scores indicate greater dispositional mindfulness (higher score = better outcome).
Measured: Baseline (pre-intervention), Week 12 (immediately post-intervention), and 3 months post-intervention (follow-up)
Change in Mental Health Symptoms (DASS-21)
Assessed using the validated Brazilian Portuguese version of the Depression, Anxiety and Stress Scale (DASS-21). The DASS-21 is a 21-item instrument assessing symptoms of depression, anxiety, and stress across three subscales of seven items each. Subscale scores are calculated as the sum of seven items multiplied by two, yielding a range of 0 to 42 per subscale. Scores correspond to severity levels ranging from normal to extremely severe. Higher scores indicate greater symptom severity (higher score = worse outcome). Subscale scores are reported separately.
Measured: Baseline (pre-intervention), Week 12 (immediately post-intervention), and 3 months post-intervention (follow-up)
Change in Body Appreciation (BAS-2)
Assessed using the validated Brazilian Portuguese version of the Body Appreciation Scale-2 (BAS-2). The 10-item scale evaluates acceptance, favorable opinions, and respect toward one's own body, demonstrating a one-dimensional structure with adequate internal consistency and construct validity. The total score is calculated as the mean of all items, ranging from 1 to 5. Higher scores indicate greater body appreciation (higher score = better outcome).
Measured: Baseline (pre-intervention), Week 12 (immediately post-intervention), and 3 months post-intervention (follow-up)
Change in Disordered Eating Attitudes (DEAS)
Assessed using the Brazilian Portuguese version of the Disordered Eating Attitude Scale (DEAS). The DEAS is a 25-item questionnaire that assesses the individual's eating attitudes, evaluating distorted beliefs, thoughts, feelings, and relationship with food across five subscales. Total scores range from 37 to 190, with higher scores indicating greater disordered eating attitudes (higher score = worse outcome)
Measured: Baseline (pre-intervention), Week 12 (immediately post-intervention), and 3 months post-intervention (follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated in a 1:1 ratio to one of two parallel arms: the experimental group or the active control group. Both arms will run concurrently for 12 weeks. Participants in both groups will be evaluated at three identical time points: baseline, immediately post-intervention (12 weeks), and at a 3-month follow-up.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilander Pereira Nunes Filho, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573410
- Sponsor's protocol ID
- 96451726.0.0000.5152
- Other IDs
- U1111-1340-1295
- Status last verified
- Apr 2026
- First submitted
- 1 May 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Silva TA, Flores AT, Buttros TS, Motarelli JHF, Pena GDG, Penaforte FRO, Japur CC. Mindfulness-Based Eating Solution (MBES) for Body Dissatisfaction and Disordered Eating Attitudes in Nutrition Students During the COVID-19 Pandemic: A Randomised Clinical Trial. J Hum Nutr Diet. 2025 Apr;38(2):e70040. doi: 10.1111/jhn.70040.
PubMed 40091515Bush HE, Rossy L, Mintz LB, Schopp L. Eat for life: a work site feasibility study of a novel mindfulness-based intuitive eating intervention. Am J Health Promot. 2014 Jul-Aug;28(6):380-8. doi: 10.4278/ajhp.120404-QUAN-186. Epub 2013 Aug 13.
PubMed 23941103
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Mindful Eating Intervention on Eating Behavior, Body Image, and Mental Health in Female Nutrition Students: a Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07573410
- Acronym / sponsor ID
- 96451726.0.0000.5152
- Conditions
- Mental Health, Body Image, Feeding Behavior, Feeding and Eating Disorders, Stress and Anxiety
- Keywords
- mindful eating, feeding behavior, Students, mental health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 7 May 2026 (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 pilot randomized clinical trial is to evaluate the efficacy of a mindful eating intervention ("Eat for Life") on eating behavior, body image, and mental health in female nutrition students. The main questions it aims to answer are: Does a mindful eating intervention reduce disordered eating behaviors in female nutrition students? Does the intervention improve body appreciation, mindfulness levels, and mental health?
Researchers will compare an active control group receiving nutritional guidance to an intervention group participating in the "Eat for Life" mindful eating program to see if the mindful eating intervention reduces disordered eating behaviors and improves overall psychological well-being and body appreciation.
Participants will: Complete online questionnaires evaluating eating behavior, mindfulness, mental health, and body image at three distinct time points: before the intervention (baseline), post-intervention, and at a 3-month follow-up.
If assigned to the intervention group, attend 12 weekly face-to-face mindful eating sessions lasting approximately two hours each. If assigned to the active control group, receive weekly informative leaflets via WhatsApp with nutritional guidance based on the Dietary Guidelines for the Brazilian Population for 12 weeks
Detailed description
Female nutrition students are particularly vulnerable to disordered eating, mental health distress (such as anxiety and depression), and body image dissatisfaction due to intense academic and sociocultural pressures. The mindful eating protocol "Eat for Life" aims to address these issues by promoting mindfulness, emotional regulation, self-compassion, and body appreciation. Despite its potential, there is a lack of randomized clinical trials (RCTs) evaluating the efficacy of this specific protocol in this population.
This parallel-group, pilot randomized clinical trial aims to fill this gap, strictly adhering to the CONSORT (Consolidated Standards of Reporting Trials) guidelines. Participants will be allocated into two distinct groups using a computerized random number generator (www.randomizar.org).
Study Procedures and Data Management: Data collection will be conducted via online forms at three specific time points: baseline, 12 weeks (post-intervention), and a 3-month follow-up. To ensure rigorous data security and quality assurance in compliance with the Brazilian General Data Protection Law (LGPD), all collected data will be exported and stored securely in offline Excel spreadsheets. Only the core research team will have access to this information, and all records will be permanently destroyed after five years to guarantee confidentiality
Sample Size Assessment: The sample size was calculated using G*Power software. To detect a moderate effect size (f = 0.15) with a minimum statistical power of 80% and a 5% significance level across two groups and three measurement times, a minimum of 74 participants is required. Anticipating a potential 20% attrition rate (loss to follow-up), the final target sample size was established at 88 participants, meaning 44 individuals randomly distributed to each arm.
Statistical Analysis Plan: To minimize bias, all statistical analyses will be performed by an independent researcher blinded to the group allocations. The analyses will be conducted using STATA and R software. Descriptive statistics will be presented as means and standard deviations for continuous variables, and as absolute and relative frequencies for categorical data. Data normality will be assessed using the Shapiro-Wilk test. For comparisons between groups, parametric (Student's t-test) or non-parametric (Mann-Whitney test) tests will be applied based on the data distribution. Correlation analyses will utilize Pearson or Spearman tests, and all tests will adopt a significance level of 5% (p < 0.05). Methodological quality will also be evaluated using the CONSORT checklist.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated in a 1:1 ratio to one of two parallel arms: the experimental group or the active control group. Both arms will run concurrently for 12 weeks. Participants in both groups will be evaluated at three identical time points: baseline, immediately post-intervention (12 weeks), and at a 3-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Eat for Life Program | Experimental | Behavioral: "Eat for Life" Mindful Eating ProgramParticipants assigned to this arm will undergo the "Eat for Life" mindful eating program. This face-to-face intervention lasts for 12 weeks, with weekly sessions of approximately two hours conducted by a certified researcher. The protocol includes formal mindfulness practices, group discussions, and reflections on personal values, body acceptance, and body appreciation. |
| Active Comparator: Nutritional Guidance | Active comparator | Behavioral: Standard Nutritional GuidanceParticipants assigned to this arm will receive standard nutritional guidance. Informational leaflets based on the Dietary Guidelines for the Brazilian Population will be sent weekly via WhatsApp over a concurrent 12-week period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female gender
- Active enrollment in the Nutrition undergraduate program at the time of data collection
- Agreement to participate in the study
Key exclusion criteria (2 listed)
- Diagnosis of severe cognitive or mental disorders; Regular practice (at least once a week in the last six months) of meditation, yoga, or mindfulness
- Regular practice (at least once a week in the last six months) of meditation, yoga, or mindfulness
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 |
|---|---|---|
| "Eat for Life" Mindful Eating ProgramA 12-week face-to-face mindful eating behavioral intervention. Participants will attend weekly sessions of approximately two hours led by a certified researcher. The program integrates formal mindfulness practices, group discussions, and reflections on personal values, self-compassion, body acceptance, and body appreciation to promote a conscious relationship with food, emotions, and the body. | Behavioural | Experimental: Eat for Life Program |
| Standard Nutritional GuidanceAn active control intervention consisting of standard nutritional education. Participants will receive informative leaflets weekly via WhatsApp over a 12-week period. The content is based on the "Dietary Guidelines for the Brazilian Population" (Guia Alimentar para a População Brasileira), providing standard health and nutrition information without any mindfulness or mindful eating components. | Behavioural | Active Comparator: Nutritional Guidance |
Primary outcome
Change in Disordered Eating Attitudes and Behaviors (EAT-26)
Time frame: Baseline (pre-intervention), Week 12 (immediately post-intervention), and 3 months post-intervention (follow-up).
Assessed using the validated Brazilian Portuguese version of the Eating Attitudes Test (EAT-26). Each item is answered on a 6-point Likert scale, with total scores ranging from 0 to 78. Higher scores indicate greater severity of disordered eating attitudes and behaviors. A score of 21 or above indicates a positive screening for disordered eating (higher score = worse outcome).
5 secondary outcomes
Change in Intuitive Eating Behaviors (IES-2)
Time frame: Baseline (pre-intervention), Week 12 (immediately post-intervention), and 3 months post-intervention (follow-up)
Change in Mindfulness Levels (FFMQ)
Time frame: Baseline (pre-intervention), Week 12 (immediately post-intervention), and 3 months post-intervention (follow-up)
Change in Mental Health Symptoms (DASS-21)
Time frame: Baseline (pre-intervention), Week 12 (immediately post-intervention), and 3 months post-intervention (follow-up)
Change in Body Appreciation (BAS-2)
Time frame: Baseline (pre-intervention), Week 12 (immediately post-intervention), and 3 months post-intervention (follow-up)
Change in Disordered Eating Attitudes (DEAS)
Time frame: Baseline (pre-intervention), Week 12 (immediately post-intervention), and 3 months post-intervention (follow-up).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Results publication: PubMed 40091515Silva TA, Flores AT, Buttros TS, Motarelli JHF, Pena GDG, Penaforte FRO, Japur CC. Mindfulness-Based Eating Solution (MBES) for Body Dissatisfaction and Disordered Eating Attitudes in Nutrition Students During the COVID-19 Pandemic: A Randomised Clinical Trial. J Hum Nutr Diet. 2025 Apr;38(2):e70040. doi: 10.1111/jhn.70040.
- Results publication: PubMed 23941103Bush HE, Rossy L, Mintz LB, Schopp L. Eat for life: a work site feasibility study of a novel mindfulness-based intuitive eating intervention. Am J Health Promot. 2014 Jul-Aug;28(6):380-8. doi: 10.4278/ajhp.120404-QUAN-186. Epub 2013 Aug 13.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Eat for Life" Mindful Eating Program and Standard Nutritional Guidance in people with Mental Health and Body Image, run by Federal University of Uberlandia 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 2 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: opening soon, as of the sponsor's last update on 11 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nilander P Nunes Filho, B.Sc (+55(34)996897015, nilanderfilho@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Disordered Eating Attitudes and Behaviors (EAT-26) (time frame: Baseline (pre-intervention), Week 12 (immediately post-intervention), and 3 months post-intervention (follow-up).). 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 NCT07573410, which also lists 2 linked publications.
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 11 May 2026.