Effects of Mindful Eating on Female Nutrition Students

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

Overview

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.

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Interventions

• Behavioral "Eat for Life" Mindful Eating Program
  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.
• Behavioral Standard Nutritional Guidance
  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.

Primary outcome measures

• 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).]

Secondary outcome measures (5)

• 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).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Brazil · 1 center

• Universidade Federal de Uberlândia (UFU) - Campus Umuarama — Uberlândia

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. PMID 40091515
• 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. PMID 23941103

Identifiers

NCT: NCT07573410 · 96451726.0.0000.5152 · U1111-1340-1295

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗