search
Back to results

Effect of Mindful Eating on Weight Management in Breast Cancer Survivors

Primary Purpose

Breast Neoplasm Female

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindful eating intervention
Sponsored by
University of Georgia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Neoplasm Female focused on measuring Obesity, Mindful eating, Postmenopausal breast cancer survivors, Weight management, Cardiovascular health

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Mindful eating intervention

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Body Mass Index
    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).
    Blood Pressure
    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.
    Waste and Hip Circumference
    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.
    Body Fat Percentage
    At the baseline and follow-up visits, trained study staff measured participants' body fat percentage using a bioelectrical impedance analyzer (BIA).
    Feasibility of Conducting the Intervention
    Feasibility was assessed by tracking participant accrual and retention rates.
    Acceptability of the Intervention
    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.

    Secondary Outcome Measures

    Mindful Eating Measures
    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.

    Full Information

    First Posted
    May 24, 2019
    Last Updated
    May 31, 2019
    Sponsor
    University of Georgia
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03972540
    Brief Title
    Effect of Mindful Eating on Weight Management in Breast Cancer Survivors
    Official Title
    Effect of a Mindful Eating Intervention on Weight Management in Overweight and Obese Postmenopausal Breast Cancer Survivors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    May 9, 2016 (Actual)
    Primary Completion Date
    July 29, 2016 (Actual)
    Study Completion Date
    October 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Georgia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Neoplasm Female
    Keywords
    Obesity, Mindful eating, Postmenopausal breast cancer survivors, Weight management, Cardiovascular health

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    13 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mindful eating intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mindful eating intervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Body Mass Index
    Description
    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).
    Time Frame
    Change measured between weeks 1 and 12
    Title
    Blood Pressure
    Description
    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.
    Time Frame
    Change measured between weeks 1 and 12
    Title
    Waste and Hip Circumference
    Description
    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.
    Time Frame
    Change measured between weeks 1 and 12
    Title
    Body Fat Percentage
    Description
    At the baseline and follow-up visits, trained study staff measured participants' body fat percentage using a bioelectrical impedance analyzer (BIA).
    Time Frame
    Change measured between weeks 1 and 12
    Title
    Feasibility of Conducting the Intervention
    Description
    Feasibility was assessed by tracking participant accrual and retention rates.
    Time Frame
    Measured at week 12
    Title
    Acceptability of the Intervention
    Description
    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.
    Time Frame
    Measured at week 12
    Secondary Outcome Measure Information:
    Title
    Mindful Eating Measures
    Description
    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.
    Time Frame
    Change measured between weeks 1 and 12
    Other Pre-specified Outcome Measures:
    Title
    Nutritional Intake
    Description
    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.
    Time Frame
    Change measured between weeks 1 and 12
    Title
    Physical Activity
    Description
    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.
    Time Frame
    Change measured between weeks 1 and 12

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect of Mindful Eating on Weight Management in Breast Cancer Survivors

    We'll reach out to this number within 24 hrs