- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07573410
Effects of Mindful Eating on Female Nutrition Students
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.
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
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Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nilander P Nunes Filho, B.Sc
- Phone Number: +55(34)996897015
- Email: nilanderfilho@gmail.com
Study Locations
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Minas Gerais (MG)
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Uberlândia, Minas Gerais (MG), Brazil, 38405-318
- Universidade Federal de Uberlândia (UFU) - Campus Umuarama
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Principal Investigator:
- Nilander P Nunes Filho, B.Sc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female gender
- Active enrollment in the Nutrition undergraduate program at the time of data collection
- Agreement to participate in the study
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental: Eat for Life Program
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.
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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.
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Active Comparator: Active Comparator: Nutritional Guidance
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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).
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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).
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Baseline (pre-intervention), Week 12 (immediately post-intervention), and 3 months post-intervention (follow-up).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Intuitive Eating Behaviors (IES-2)
Time Frame: Baseline (pre-intervention), Week 12 (immediately post-intervention), and 3 months post-intervention (follow-up)
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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).
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Baseline (pre-intervention), Week 12 (immediately post-intervention), and 3 months post-intervention (follow-up)
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Change in Mindfulness Levels (FFMQ)
Time Frame: Baseline (pre-intervention), Week 12 (immediately post-intervention), and 3 months post-intervention (follow-up)
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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).
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Baseline (pre-intervention), Week 12 (immediately post-intervention), and 3 months post-intervention (follow-up)
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Change in Mental Health Symptoms (DASS-21)
Time Frame: Baseline (pre-intervention), Week 12 (immediately post-intervention), and 3 months post-intervention (follow-up)
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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.
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Baseline (pre-intervention), Week 12 (immediately post-intervention), and 3 months post-intervention (follow-up)
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Change in Body Appreciation (BAS-2)
Time Frame: Baseline (pre-intervention), Week 12 (immediately post-intervention), and 3 months post-intervention (follow-up)
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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).
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Baseline (pre-intervention), Week 12 (immediately post-intervention), and 3 months post-intervention (follow-up)
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Change in Disordered Eating Attitudes (DEAS)
Time Frame: Baseline (pre-intervention), Week 12 (immediately post-intervention), and 3 months post-intervention (follow-up).
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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)
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Baseline (pre-intervention), Week 12 (immediately post-intervention), and 3 months post-intervention (follow-up).
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Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Bush 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Signs and Symptoms, Digestive
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Personal Satisfaction
- Behavior, Animal
- Anxiety Disorders
- Feeding and Eating Disorders
- Psychological Well-Being
- Feeding Behavior
- Diet, Food, and Nutrition
- Physiological Phenomena
- Nutritional Physiological Phenomena
- Digestive System Physiological Phenomena
- Digestive System and Oral Physiological Phenomena
- Eating
Other Study ID Numbers
- 96451726.0.0000.5152
- U1111-1340-1295 (Other Identifier: World Health Organization)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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