Effect of Mindful Eating on Weight Management in Breast Cancer Survivors
Effect of a Mindful Eating Intervention on Weight Management in Overweight and Obese Postmenopausal Breast Cancer Survivors
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
Typ studiów
Typ studiów
Zapisy (Rzeczywisty)
Zapisy
Faza
Faza
- Nie dotyczy
Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Postmenopausal female
- Breast cancer survivor (in remission)
- Completed cancer treatment at the time of study enrollment
- Body Mass Index (BMI) equal or greater than 25 kg/m²
Exclusion Criteria:
- None.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
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Eksperymentalny: Mindful eating intervention
The mindful eating intervention was taught by a mindfulness-based stress reduction instructor certified by the Center of Mindfulness at the University of Massachusetts Medical School.
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A Mindful Eating Workshop™ workbook was used for standardization and reproducibility of these sessions.
The group sessions were focused on teaching applied strategies to consume food with intention and attention and aimed at improving emotional relationships with food.
Intervention sessions were held once a week in the evening for 2 hours per session over 8 weeks.
The intervention was delivered in a large conference room on the University of Georgia campus.
Participants were required to attend seven out of eight sessions.
If participants missed a session, they met with the instructor 30 minutes before the beginning of the following week's session to receive individual instruction on content of the missed session.
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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Body Mass Index
Ramy czasowe: Change measured between weeks 1 and 12
|
At the baseline and follow-up visits, trained study staff measured participants' weight and height using a standardized protocol.
Height (measured by a stadiometer to the nearest 0.1 cm) and weight (measured by a scale to the nearest 0.1 kg) was used to calculate BMI (weight in kg divided by height in m²).
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Change measured between weeks 1 and 12
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Blood Pressure
Ramy czasowe: Change measured between weeks 1 and 12
|
At the baseline and follow-up visits, trained study staff measured participants' systolic/diastolic blood pressure using a standardized protocol to the nearest mmHg.
In order to ensure reliability, all measurements were taken 3 times and average values were used for analyses.
|
Change measured between weeks 1 and 12
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Waste and Hip Circumference
Ramy czasowe: Change measured between weeks 1 and 12
|
At the baseline and follow-up visits, trained study staff measured participants' waist and hip circumference by tape measure to the nearest 0.1 centimeter.
|
Change measured between weeks 1 and 12
|
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Body Fat Percentage
Ramy czasowe: Change measured between weeks 1 and 12
|
At the baseline and follow-up visits, trained study staff measured participants' body fat percentage using a bioelectrical impedance analyzer (BIA).
|
Change measured between weeks 1 and 12
|
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Feasibility of Conducting the Intervention
Ramy czasowe: Measured at week 12
|
Feasibility was assessed by tracking participant accrual and retention rates.
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Measured at week 12
|
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Acceptability of the Intervention
Ramy czasowe: Measured at week 12
|
To measure acceptability, participants were asked to complete a 5-question feedback survey to evaluate the mindful eating intervention at the follow-up study visit.
Specifically, the open-ended survey questions asked participants about (1) their experience with intervention, (2) how the intervention affected diet and exercise management, (3) positive aspects about the intervention, (4) negative aspects about the intervention, and (5) suggested changes to the intervention.
Qualitative data analysis techniques were used to identify themes within the data.
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Measured at week 12
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Mindful Eating Measures
Ramy czasowe: Change measured between weeks 1 and 12
|
Changes in mindfulness resulting from the intervention were measured using the validated Mindful Attention Awareness Scale (MAAS).
The MAAS questionnaire is a 15-item scale that was designed to assess mindfulness and receptive awareness throughout an individual's daily life.
Scores from the MAAS range from 1 to 6, with higher scores associated with higher mindfulness.
The MAAS was validated for use in cancer populations against the Profile of Mood States (POMS) scale that is widely used in clinical settings.
Higher MAAS scores were significantly correlated with lower POMS scores, further confirming the construct validity of the MAAS questionnaire for assessing mindfulness in cancer populations.
The questionnaire was self-administered to the participants pre and post intervention.
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Change measured between weeks 1 and 12
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Inne miary wyników
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Nutritional Intake
Ramy czasowe: Change measured between weeks 1 and 12
|
Habitual nutritional intake was measured using an electronic version of the Block Food Frequency Questionnaire, a 127-item food and beverage recall instrument referencing the consumption over the past month.
Dietary intake data was describes as daily energy consumption (kcal), consumption of macronutrients (fat, protein, carbohydrate; grams/day), and intake of sweets (% of daily intake) to compare intake before intervention start with intake during the intervention.
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Change measured between weeks 1 and 12
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Physical Activity
Ramy czasowe: Change measured between weeks 1 and 12
|
Participants' physical activity levels (average daily steps; moderate-to-vigorous physical activity (MVPA) minutes) were tracked throughout the study period using FitBit® Flex accelerometers.
Total daily steps and MVPA minutes were averaged for the first and the last week of the intervention to examine changes.
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Change measured between weeks 1 and 12
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Współpracownicy i badacze
Sponsor
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Zakończenie podstawowe
Ukończenie studiów (Rzeczywisty)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- STUDY00002818
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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