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临床试验/NCT03972540
NCT03972540已完成不适用

Effect of a Mindful Eating Intervention on Weight Management in Overweight and Obese Postmenopausal Breast Cancer Survivors

University of Georgia0 个研究点目标入组 13 人开始时间: 2016年5月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
13
主要终点
Blood Pressure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

  • 未提供

研究组 & 干预措施

Mindful eating intervention

Experimental

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.

干预措施: Mindful eating intervention (Behavioral)

结局指标

主要结局

Blood Pressure

时间窗: 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.

Acceptability of the Intervention

时间窗: 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.

Body Mass Index

时间窗: 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).

Feasibility of Conducting the Intervention

时间窗: Measured at week 12

Feasibility was assessed by tracking participant accrual and retention rates.

Waste and Hip Circumference

时间窗: 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.

Body Fat Percentage

时间窗: 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).

次要结局

  • Mindful Eating Measures(Change measured between weeks 1 and 12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elisabeth Lilian Pia Sattler, Ph.D., B.S. Pharm

Assistant Professor

University of Georgia

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