Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT07007104
Brief Summary:
The goal of this clinical trial is to explore whether a mindful eating intervention can improve eating behaviors and support sustainable weight management among female breast cancer survivors in Türkiye who have completed active treatment.
The main questions it aims to answer are:
* Can a structured mindful eating program improve intuitive and mindful eating behaviors?
* Does the intervention lead to favorable changes in body weight, BMI, waist circumference, and fat mass compared to usual care?
Researchers will compare a group receiving a 6-session mindful eating intervention plus treatment-as-usual (MEI + TAU) to a treatment-as-usual (TAU) control group to see if the intervention provides additional benefits on eating behaviors and body composition.
Participants will:
* Attend six 60-90 minute group sessions on mindful eating delivered by trained professionals
* Receive tailored nutrition education from an oncology dietitian
* Complete validated questionnaires (IES-2 and MEQ-30) and anthropometric assessments at baseline and follow-up
Detailed Description:
This randomized controlled pilot study investigates the effects of a six-session mindful eating intervention (MEI) on eating behaviors and body composition among female breast cancer (BC) survivors in Türkiye. Participants were recruited from a medical oncology clinic and were eligible if they had completed surgery, chemotherapy, and radiotherapy, with or without ongoing hormone therapy, at least six months prior to enrollment. A total of 25 participants were randomly assigned to one of two groups: (1) MEI combined with treatment-as-usual (MEI + TAU, n = 12) and (2) treatment-as-usual alone (TAU, n = 13).
The MEI consisted of six weekly 60-90 minute sessions led by a trained mindful eating facilitator and a registered dietitian with oncology experience. Sessions addressed themes such as recognizing hunger and satiety cues, slowing down during meals, managing emotional eating, and enhancing sensory awareness. Participants also received individualized nutritional counseling based on their anthropometric data and dietary habits.
Data were collected at baseline and multiple follow-up points across six months. Outcomes included body weight, BMI, waist circumference, fat mass, and scores from two validated behavioral questionnaires: the Intuitive Eating Scale-2 (IES-2) and the Mindful Eating Questionnaire-30 (MEQ-30). Body composition was assessed using bioelectrical impedance analysis (BIA), and statistical analysis was performed to evaluate within-group and between-group changes over time.
Preliminary results suggest that participants in the MEI + TAU group experienced significant improvements in intuitive eating scores, particularly in reliance on hunger/satiety cues and reduced emotional eating. Mindful eating scores also increased across several subscales, and reductions in waist circumference were more pronounced in the intervention group. These findings indicate that mindful eating interventions may support sustainable weight management and improved eating behaviors in breast cancer survivors. Further large-scale studies are warranted to confirm these outcomes and explore long-term effects on survivorship and recurrence risk.
Study:
NCT07007104
Study Brief:
Protocol Section:
NCT07007104