- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03972540
Effect of Mindful Eating on Weight Management in Breast Cancer Survivors
31. mai 2019 oppdatert av: Elisabeth Lilian Pia Sattler, Ph.D., B.S. Pharm, University of Georgia
Effect of a Mindful Eating Intervention on Weight Management in Overweight and Obese Postmenopausal Breast Cancer Survivors
This pilot study examined changes in anthropometric measures as a result of and feasibility/ acceptability of a mindful eating intervention for overweight and obese postmenopausal breast cancer survivors.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Being overweight is associated with increased risk for chronic disease and premature death in breast cancer survivors.
This pilot study examined changes in anthropometric measures as a result of and feasibility/ acceptability of a mindful eating intervention for overweight and obese postmenopausal breast cancer survivors.
The one-group pre-posttest study design included eight weekly group-based mindful eating sessions on strategies to intentionally and attentively consume food.
Anthropometrics, blood pressure, mindfulness, nutritional intake, and physical activity were collected at baseline and 12-weeks follow-up.
Data on feasibility and acceptability were collected at study completion.
Studietype
Intervensjonell
Registrering (Faktiske)
13
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
50 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Body Mass Index
Tidsramme: 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).
|
Change measured between weeks 1 and 12
|
Blood Pressure
Tidsramme: 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
|
Waste and Hip Circumference
Tidsramme: 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
|
Body Fat Percentage
Tidsramme: 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
|
Feasibility of Conducting the Intervention
Tidsramme: Measured at week 12
|
Feasibility was assessed by tracking participant accrual and retention rates.
|
Measured at week 12
|
Acceptability of the Intervention
Tidsramme: 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.
|
Measured at week 12
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Mindful Eating Measures
Tidsramme: 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.
|
Change measured between weeks 1 and 12
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Nutritional Intake
Tidsramme: 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.
|
Change measured between weeks 1 and 12
|
Physical Activity
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
9. mai 2016
Primær fullføring (Faktiske)
29. juli 2016
Studiet fullført (Faktiske)
31. oktober 2016
Datoer for studieregistrering
Først innsendt
24. mai 2019
Først innsendt som oppfylte QC-kriteriene
31. mai 2019
Først lagt ut (Faktiske)
3. juni 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. juni 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
31. mai 2019
Sist bekreftet
1. mai 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY00002818
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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