Effect of Mindful Eating on Weight Management in Breast Cancer Survivors
2019年5月31日 更新者: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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
13
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的: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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Body Mass Index
大体时间:Change measured between weeks 1 and 12
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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
大体时间:Change measured between weeks 1 and 12
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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.
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Change measured between weeks 1 and 12
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Waste and Hip Circumference
大体时间:Change measured between weeks 1 and 12
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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.
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Change measured between weeks 1 and 12
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Body Fat Percentage
大体时间:Change measured between weeks 1 and 12
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At the baseline and follow-up visits, trained study staff measured participants' body fat percentage using a bioelectrical impedance analyzer (BIA).
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Change measured between weeks 1 and 12
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Feasibility of Conducting the Intervention
大体时间:Measured at week 12
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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
大体时间:Measured at week 12
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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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Mindful Eating Measures
大体时间:Change measured between weeks 1 and 12
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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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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Nutritional Intake
大体时间:Change measured between weeks 1 and 12
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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
大体时间:Change measured between weeks 1 and 12
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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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年5月9日
初级完成 (实际的)
2016年7月29日
研究完成 (实际的)
2016年10月31日
研究注册日期
首次提交
2019年5月24日
首先提交符合 QC 标准的
2019年5月31日
首次发布 (实际的)
2019年6月3日
研究记录更新
最后更新发布 (实际的)
2019年6月3日
上次提交的符合 QC 标准的更新
2019年5月31日
最后验证
2019年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Mindful eating intervention的临床试验
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动,不招人
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动,不招人
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University of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Splendor-NC招聘中