- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07605104
Mindful Bites: Eating in the Present Moment
Mindful Bites: Eating in the Present Moment. A Study Within the PNRR 10 ON FOODS PARTNERSHIP
Přehled studie
Postavení
Podmínky
Detailní popis
This study investigates the short-term effects of a two-week app-based mindful eating intervention delivered through MyPocketHealth. The intervention is designed to promote greater awareness of eating experiences, including sensory perception, emotional states, and behavioral patterns related to food consumption. Participants receive daily training exercises and short audio modules tailored to the principles of mindfulness applied to eating.
Throughout the 14-day program, participants complete daily momentary assessments assessing mood, attention, and eating-related awareness. Additional pre- and post-intervention questionnaires evaluate psychological well-being (WHO-5), cognitive failures (CFQ), eating behavior styles (DEBQ), and mindful eating skills (MEQ). Dietary habits, intake of specific food groups and dispositional mindfulness are also assessed to explore possible changes associated with the intervention.
The primary aim of the study is to evaluate changes in psychological well-being and mindful eating from baseline to the end of the intervention. Secondary aims include assessing changes in cognitive functioning, eating behavior patterns, and day-to-day fluctuations in mood and attentional engagement with the training materials. Group differences are explored across three experimental conditions, which vary in the level of content emphasis. Group 1 listens to general food-related podcast (MEE), group 2 listens to a podcast discussing theoretical information about mindful eating (MET), while group 3 listens to a podcast that, besides theoretical information, also offers daily practices (MEP).
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Milan, Itálie, 20126
- Piazza dell'Ateneo Nuovo 1
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- owning a smartphone
Exclusion Criteria:
- presence of diagnosed eating disorders
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Mindful Eating Practice
Participants receive notifications focused on experiential mindful eating components, including awareness of the five senses and interoceptive skills.
They also complete specific guided exercises designed to cultivate these abilities.
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Participants complete a 14-day app-based program delivered through daily notifications and short audio content focused on experiential mindful eating components, including awareness of the five senses and interoceptive skills.
They also complete specific guided exercises designed to cultivate these abilities.
Each day, participants receive two notifications and one short audio, accompanied by brief self-report assessments evaluating mood, attention, and engagement.
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Experimentální: Mindful Eating Theory
Participants receive notifications focused exclusively on the theoretical aspects of mindful eating, without the experiential exercises included in the practice condition.
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Participants complete a 14-day app-based program delivered through daily notifications and short audio content focused exclusively on the theoretical aspects of mindful eating, without the experiential exercises included in the practice condition.
They also complete specific guided exercises designed to cultivate these abilities.
Each day, participants receive two notifications and one short audio, accompanied by brief self-report assessments evaluating mood, attention, and engagement.
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Experimentální: Mindful Eating Education
Participants receive notifications promoting evidence-based healthy eating practices, such as adequate water intake and reduced consumption of refined foods, based on findings from authoritative scientific research.
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Participants complete a 14-day app-based program delivered through daily notifications and short audio content promoting evidence-based healthy eating practices, such as adequate water intake and reduced consumption of refined foods, based on findings from authoritative scientific research.
They also complete specific guided exercises designed to cultivate these abilities.
Each day, participants receive two notifications and one short audio, accompanied by brief self-report assessments evaluating mood, attention, and engagement.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Mood assessment
Časové okno: Immediately before and after each daily session over the 14-day period
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Mood was assessed daily throughout the 14-day intervention period using five single-item Likert scales (1-10).
Participants rated their momentary levels of stress, mental clarity, calmness, happiness, and restlessness.
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Immediately before and after each daily session over the 14-day period
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Mindful Eating Awareness
Časové okno: At baseline and at the end of the 14-day intervention period
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To assess Mindful Eating Awareness, we used the Mindful Eating Questionnaire (MEQ), a tool developed to measure the degree of awareness during eating behavior.
In the Italian abbreviated version (Clementi, Casu, & Gremigni, 2017), the instrument consists of 20 items rated on a 4-point Likert scale (from 1 = 'Never' to 4 = 'Always') and is divided into two subscales: awareness and recognition.
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At baseline and at the end of the 14-day intervention period
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Bodily Sensation
Časové okno: Immediately after each daily session over the 14-day period
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Bodily sensation was assessed daily throughout the 14-day intervention period using five single-item Likert scales (1-10).
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Immediately after each daily session over the 14-day period
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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WHO-5 Well-Being Index score
Časové okno: At baseline and at the end of the 14-day intervention period
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Well-being was assessed using the WHO-5 Well-Being Index, a self-report questionnaire that measures subjective psychological well-being over the previous two weeks.
The scale consists of five positively worded items rated on a 6-point Likert scale, with higher scores indicating greater well-being.
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At baseline and at the end of the 14-day intervention period
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Cognitive Failures Questionnaire (CFQ) score
Časové okno: At baseline and at the end of the 14-day intervention period
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Cognitive efficiency was evaluated using the Cognitive Failures Questionnaire (CFQ), a self-report measure assessing the frequency of everyday cognitive lapses over the previous two weeks. The questionnaire consists of 25 items, each describing common cognitive slips involving attention, memory, or action execution (e.g., forgetting why one entered a room, losing focus during tasks, or misplacing objects). Items are rated on a 5-point Likert scale ranging from 0 ("Never") to 4 ("Very often"), with higher scores indicating more frequent cognitive failures. |
At baseline and at the end of the 14-day intervention period
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Patrizia Steca, University of Milan-Bicocca
- Vrchní vyšetřovatel: Maria Elide Vanutelli, University of Milan-Bicocca
Publikace a užitečné odkazy
Obecné publikace
- Dalen J, Smith BW, Shelley BM, Sloan AL, Leahigh L, Begay D. Pilot study: Mindful Eating and Living (MEAL): weight, eating behavior, and psychological outcomes associated with a mindfulness-based intervention for people with obesity. Complement Ther Med. 2010 Dec;18(6):260-4. doi: 10.1016/j.ctim.2010.09.008. Epub 2010 Nov 11.
- Salvo V, Curado DF, Sanudo A, Kristeller J, Schveitzer MC, Favarato ML, Isidoro W, Demarzo M. Comparative effectiveness of mindfulness and mindful eating programmes among low-income overweight women in primary health care: A randomised controlled pragmatic study with psychological, biochemical, and anthropometric outcomes. Appetite. 2022 Oct 1;177:106131. doi: 10.1016/j.appet.2022.106131. Epub 2022 Jun 23.
- Lyzwinski LN, Edirippulige S, Caffery L, Bambling M. Mindful Eating Mobile Health Apps: Review and Appraisal. JMIR Ment Health. 2019 Aug 22;6(8):e12820. doi: 10.2196/12820.
- Janssen LK, Duif I, van Loon I, de Vries JHM, Speckens AEM, Cools R, Aarts E. Greater mindful eating practice is associated with better reversal learning. Sci Rep. 2018 Apr 9;8(1):5702. doi: 10.1038/s41598-018-24001-1.
- Begin C, Berthod J, Martinez LZ, Truchon M. Use of Mobile Apps and Online Programs of Mindfulness and Self-Compassion Training in Workers: A Scoping Review. J Technol Behav Sci. 2022;7(4):477-515. doi: 10.1007/s41347-022-00267-1. Epub 2022 Sep 6.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- RM-2025-974
- PE00000003;CUP D93C22000890001 (Jiné číslo grantu/financování: Italian Ministry of University and Research funded by the European Union - NextGenerationEU)
Plán pro data jednotlivých účastníků (IPD)
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Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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