有子宫内膜癌风险的夏威夷原住民/太平洋岛民妇女的限时饮食 (TRE) (TIMESPAN)
有子宫内膜癌风险的夏威夷原住民/太平洋岛民妇女限时饮食 (TRE) 的可行性和可接受性
研究概览
详细说明
入学： 该研究包括两个阶段。 第一阶段包括 30 名有子宫内膜癌风险的夏威夷原住民/太平洋岛民妇女的焦点小组。 焦点小组将确定社会文化对 (i) 饮食行为的影响，包括进餐时间； (ii) 饮食偏好； (iii) 拟议的膳食计划和干预设计； (iv) 对减肥和身体形象的看法。 在第二个研究阶段，研究团队将招募 10 名太平洋岛民女性参加为期 14 周的随机饮食交叉研究。 每位女性都将参加两个干预组，并作为自己的对照。
焦点小组：为了完成本研究目标 1 的所有方面，研究团队将招募 30 名有子宫内膜癌风险的太平洋岛民女性进行虚拟焦点小组讨论。 这些焦点小组将通过 Zoom 等私人视频会议进行，并在必要时提供语言翻译。 焦点小组将由夏威夷原住民/太平洋岛民社区专家参加。 将设计问题以了解社会文化对饮食行为的影响（关于社交饮食、进餐时间和饮食偏好的问题，征求对研究干预实施设计的反馈，以及对减肥和身体形象的看法）。 破冰船将在正式讯问之前进行。 会议将在视频会议和附加设备上进行录音，逐字转录，并检查准确性。 另外两名团队成员将作为记录员出席。 我们的社区专家将出席以帮助促进会议。 会议开始时将提供问题，以确保文化敏感性。
饮食干预：饮食干预包括 5 次研究访问，包括一次基线访问、2 周磨合期、4 周控制饮食计划、4 周清除期和 4 周 8 至 10 小时时间限制饮食 (TRE) 方案（8 至 10 小时进食和 14 至 16 小时禁食期）。 后续调查问卷将在干预后 6 个月邮寄。 对于控制时间表，女性将获得冷冻午餐和晚餐以及标准化的早餐和小吃菜单。 所有餐点和早餐/小吃菜单的设计都将根据焦点小组的反馈设计，以符合文化要求，并且膳食计划将个性化以满足维持体重的能量需求。 对于 TRE 计划，女性将根据控制计划获得准备好的冷冻午餐和晚餐，但将被要求在适合其计划的 8 至 10 小时内食用每日正餐、零食和含卡路里的饮料。 他们将被要求保持规律的睡眠和体育锻炼计划。 禁食期将在第一周增加（第 1-3 天，每天 12-14 小时，第 4-6 天，每天 14-16 小时，第 7 天以上，每天 16 小时）。 女性将被要求每天在同一时间安排进食时间。 所有膳食（控制和 TRE）将由位于犹他大学的代谢厨房提供。
访问 1：在基线访问期间，协调员将征得参与者的同意，他们将被要求完成有关临床和人口统计因素、时间型和身体活动的问卷调查，并进行各种人体测量。 在基线访问之后，参与者将进行为期 2 周的磨合期。 在此期间，目标是记录女性平时的进食次数和食欲，同时遵循她们的习惯饮食。
访问 2：女性将提供空腹血液和粪便样本，并进行人体测量。 在访问 2 之后，参与者将接受为期 4 周的控制或 TRE 计划。
第 3 次访问：4 周后，参与者将进行第 3 次访问，并被要求提供空腹血液和粪便样本，并进行人体测量。 第 3 次访视后，参与者将经历 4 周的洗脱期，在此期间女性可以恢复正常的生活方式。
第 4 次访问：第 4 次访问将在 4 周的洗脱期之后进行，包括电话咨询以讨论下一研究阶段和安排膳食供应。 在接下来的 4 周内，参与者将接受相反的喂食计划（对照或 TRE）。
第5次访视：在最后一次访视中，女性将提供空腹血液和粪便样本，并进行人体测量。
在磨合期、TRE 阶段和控制阶段，参与者将使用 MyCircadian Clock 手机应用程序记录进食时间，完成 3 x 24 小时饮食回忆、单次身体活动回忆和 7 天睡眠身体活动将使用 Actiwatch 设备进行客观测量。 饥饿和饱腹感将通过 MyCircadian Clock 手机应用程序随机评估。
将通过 Zoom 电话会议进行研究退出面谈，以汇报干预情况并获取有关协议可接受性的详细信息。 干预期结束后大约 6 个月，女性将完成邮寄的后续调查问卷。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
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Utah
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Salt Lake City、Utah、美国、84112
- Huntsman Cancer Institute
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准：
所有目标：
- 18 岁或以上的夏威夷原住民/太平洋岛民女性
- 超重或肥胖（BMI>25kg/m2）或有非胰岛素依赖型糖尿病病史或有复杂非典型子宫内膜增生病史
- 有一部可以下载应用程序的手机
- 能够在白天使用手机（例如在工作中）
- 不是夜班工人
仅适用于目标 2 和 3：
- 能够参加亨斯迈癌症研究所希望中心的研究访问
排除标准：
所有目标：
- 无法提供知情同意
仅适用于目标 2 和 3：
- 需要特殊饮食以排除调整进餐时间和/或常量营养素含量
- 有胰岛素依赖型糖尿病病史
- 有子宫切除史
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Time Restricted Eating (TRE) Schedule, Then Control
In this arm of the 14-week randomized dietary crossover study, participants will undergo a 2-week run-in period, followed by an 8-hour TRE protocol (comprising 8 hours of feeding and 16 hours of fasting periods), a 4-week washout period, and a 4-week control diet schedule.
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Women will receive prepared frozen lunch and dinner meals as per the control schedule, but will be asked to consume daily meals, snacks, and calorie-containing beverages within an 8 to 10-hour period that fits their schedule.
They will be asked to maintain their regular sleep and physical activity schedule.
Fasting period will ramp up during the first week (e.g., Days 1-3, 12-14 h per day, Days 4-6, 14-16 h per day, Days 7+, 16 h per day).
Women will be asked to schedule the feeding period at the same time each day.
They will be allowed to consume water and 1-2 servings of very low-calorie drinks and foods (e.g., herbal tea, diet drinks, mints, gum containing < 4 kcal/serving) to increase compliance.
All meals (control and TRE) will be provided by the Metabolic Kitchen developed in collaboration with the department of Nutrition and Integrative Physiology.
Women will receive frozen lunch/dinner meals and a standardized breakfast and snacks menu.
All meals and the breakfast/snack menu will be designed to be culturally competent.
The meal plans will be individualized to meet weight maintenance energy requirements.
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实验性的：Control Schedule, Then TRE
In this arm of the 14-week randomized dietary crossover study, participants will undergo a 2-week run-in period, followed by 4-week control diet schedule, a 4-week washout period, and an 8-hour TRE protocol (comprising 8 hours of feeding and 16 hours of fasting periods)
|
Women will receive prepared frozen lunch and dinner meals as per the control schedule, but will be asked to consume daily meals, snacks, and calorie-containing beverages within an 8 to 10-hour period that fits their schedule.
They will be asked to maintain their regular sleep and physical activity schedule.
Fasting period will ramp up during the first week (e.g., Days 1-3, 12-14 h per day, Days 4-6, 14-16 h per day, Days 7+, 16 h per day).
Women will be asked to schedule the feeding period at the same time each day.
They will be allowed to consume water and 1-2 servings of very low-calorie drinks and foods (e.g., herbal tea, diet drinks, mints, gum containing < 4 kcal/serving) to increase compliance.
All meals (control and TRE) will be provided by the Metabolic Kitchen developed in collaboration with the department of Nutrition and Integrative Physiology.
Women will receive frozen lunch/dinner meals and a standardized breakfast and snacks menu.
All meals and the breakfast/snack menu will be designed to be culturally competent.
The meal plans will be individualized to meet weight maintenance energy requirements.
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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 |
|---|---|---|
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Proportion of Participants Referred That Were Consented and Enrolled
大体时间：up to 1 day after screening
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The feasibility of the Time-Restricted Eating (TRE) intervention will be measured by calculating the proportion (%) of women who were consented and enrolled in the study out of all the participants who screened for the trial.
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up to 1 day after screening
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Attrition
大体时间：From the baseline of the randomized portion of the study to Visit 5, up to 19 weeks
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To assess the feasibility of the TRE intervention.
This outcome measure will report the number of participants who withdrew throughout the course of the interventional component of the study.
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From the baseline of the randomized portion of the study to Visit 5, up to 19 weeks
|
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Protocol Items Completed
大体时间：From the baseline of the randomized portion of the study to Visit 5, up to 19 weeks
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This outcome measure will report the count of participants who completed each study assessment per protocol. Participants who were randomized and withdrew from the study are included as missed assessments. After the TRE Schedule (Visit 3 or 5), waist circumference, weight, blood pressure, blood, and stool were collected. After the Control Schedule (Visit 3 or 5), waist circumference, weight, blood pressure, blood, and stool were collected. This outcome measure will report the count of participants who completed each assessment |
From the baseline of the randomized portion of the study to Visit 5, up to 19 weeks
|
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Percentage of TRE-Adherent Days
大体时间：From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
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This outcome measure will report the mean percentage of TRE-adherent days.
TRE adherence is achieved when participants fast for 14-18 hours per day during the TRE phase, as measured by a mealtime log using the MyCircadianClock phone app.
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From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
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Meals Delivered On Schedule
大体时间：From the baseline of the randomized portion of the study to Visit 5, up to 19 weeks
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Count of participants whose pre-made control diet meals were delivered on schedule.
Participants were provided with pre-made, frozen lunch and dinner meals 7 days a week during both 4-week diet phases.
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From the baseline of the randomized portion of the study to Visit 5, up to 19 weeks
|
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Study Visit Completion
大体时间：From the baseline of the randomized portion of the study to Visit 5, up to 19 weeks
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To assess feasibility of the study, the percentage of in-person study visits completed out of 5 study visits for each participant was calculated. This outcome measure will report the mean percentage of completed study visits. This outcome measure was assessed throughout the course of the study during both the TRE and Control Schedules; it is not possible to regroup participants to report Arms/Groups "per intervention". |
From the baseline of the randomized portion of the study to Visit 5, up to 19 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Blood Pressure Measured With Electronic Blood Pressure Monitor
大体时间：From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
Blood pressure was measured using an electronic blood pressure monitor after the TRE phase and after the control diet phase.
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From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
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Waist Circumference
大体时间：From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
Waist circumference was measured by trained study staff using a tape measure and standardized protocols.
Waist circumference was measured after the TRE Schedule and after the Control Schedule.
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From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
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Body Mass Index (BMI) Assessed Via Stadiometer and Calibrated Scales
大体时间：From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
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Participants' height and weight was measured by trained study staff using a stadiometer and calibrated weighing scales.
Measures were done in triplicate (duplicate if measures did not agree).
Height and weight were used to calculate body mass index in kilograms divided by height in meters-squared.
BMI was measured after the TRE Schedule and after the Control Schedule.
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From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
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Fasting Blood Glucose Level
大体时间：From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
Fasting glucose was measured at Associated Regional and University Pathologists (ARUP) Laboratories.
Fasting blood samples were taken from participants by a trained phlebotomist using standard protocols after the TRE Schedule and after the Control Schedule.
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From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
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Fasting Blood C-peptide Level
大体时间：From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
C-peptide was measured at ARUP Laboratories.
Fasting blood samples were taken by a trained phlebotomist using standardized protocols after the TRE Schedule and after the Control Schedule.
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From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
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Fasting Blood Triglyceride Level
大体时间：From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
Blood triglyceride level was measured at ARUP Laboratories.
Fasting blood samples were taken by a trained phlebotomist using standardized protocols after the TRE Schedule and after the Control Schedule.
|
From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
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Fasting Blood High-density Lipoprotein(HDL)-Cholesterol Level
大体时间：From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
Blood HDL-cholesterol level was measured at ARUP Laboratories.
Fasting blood samples were taken by a trained phlebotomist using standardized protocols after the TRE Schedule and after the Control Schedule.
|
From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
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Fasting Blood High Sensitivity C-reactive Protein
大体时间：From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
Blood C-peptide level was measured at ARUP Laboratories.
Fasting blood samples were taken by a trained phlebotomist using standardized protocols after the TRE Schedule and after the Control Schedule.
|
From the baseline of the randomized portion of the study to Visit 3 and Visit 5, up to 19 weeks
|
合作者和调查者
调查人员
- 首席研究员：Mary Playdon, PhD, MPH、University of Utah
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 127142
- UL1TR002538 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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