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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1340-1295 | Other Identifier | World Health Organization |
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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Eat for Life" Mindful Eating Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline (pre-intervention), Week 12 (immediately post-intervention), and 3 months post-intervention (follow-up). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
Eligibility is strictly limited to individuals who self-identify as female. This gender-based restriction is applied because women represent a key demographic with a significantly higher prevalence of and vulnerability to disordered eating behaviors, body dissatisfaction, and psychological distress compared to men.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nilander P Nunes Filho, B.Sc | Contact | +55(34)996897015 | nilanderfilho@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal de Uberlândia (UFU) - Campus Umuarama | Uberlândia | Minas Gerais (MG) | 38405-318 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40091515 | Result | 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. | |
| 23941103 |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| D005247 | Feeding Behavior |
| D001068 | Feeding and Eating Disorders |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D001522 | Behavior, Animal |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| D004435 | Eating |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D004068 | Digestive System Physiological Phenomena |
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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.
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Due to the nature of the behavioral intervention (a face-to-face mindful eating program versus an active control group receiving informational leaflets), it is not feasible to blind the participants or the investigators conducting the sessions. Therefore, masking will be applied exclusively to the data analysis stage. All statistical analyses will be performed by an independent third-party researcher who will be completely blinded to the participants' group allocation (Intervention Group and Active Control Group) in order to minimize analytical bias.
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| Standard Nutritional Guidance | Behavioral | 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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| 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). | 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. | 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). | 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) | Baseline (pre-intervention), Week 12 (immediately post-intervention), and 3 months post-intervention (follow-up). |
| 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. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D055688 | Digestive System and Oral Physiological Phenomena |