Time-restricted Eating in Cancer Survivorship: A Single-arm Feasibility Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Mean Percent of Days That Participants Adhere to the TRE Dietary Pattern
研究概览
简要总结
The investigators will assess the feasibility of delivering a time-restricted eating (TRE) intervention among cancer survivors with fatigue.
详细描述
In this study, the feasibility of delivering a time-restricted eating (TRE) intervention among fatigued cancer survivors will be assessed. The participants will be asked to eat ad libitum only within a self-selected 10-h window each day for 14 days. The primary aim is to assess the adherence of the participants to the 10-h TRE intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(Participants must...)
- •Have completed adjuvant chemotherapy, surgery, and/or radiation for cancer at least 4 months and not more than 5 years prior to enrolling,
- •Have a baseline level of fatigue, as determined by reporting a score of 3 or higher for the question, "In the last week, how bad was your worst fatigue on a scale from 0-10?"
- •Be able to speak English,
- •Be at least 18 years old,
- •Be willing and able to adhere to study procedures, and
- •Be able to provide written informed consent.
排除标准
- •(Participants must not...):
- •Already eat all their food within a window that is 10 h or shorter most (6/7) days of the week,
- •Be underweight, as defined as a body mass index ≤20.0 kg/m
- •Not have surgery planned in the next month,
- •Not have any contraindications to the proposed nutrition intervention as identified by
- •their medical provider, their designee, or the study team (e.g., type 1 diabetes, risk for hypoglycemia, medication requirements, pregnancy, breastfeeding, recent history of an eating disorder),
- •Not be taking insulin, or
- •Be on enteral or parenteral nutrition.
研究组 & 干预措施
Time-restricted eating
Participants will be asked to follow a TRE meal pattern for 14 consecutive days. Participants will be encouraged to consume food and beverages only within a 10-h time window for the 14-day intervention, with the exception of water, which will be encouraged at any time.
干预措施: Time-restricted eating (Behavioral)
结局指标
主要结局
Mean Percent of Days That Participants Adhere to the TRE Dietary Pattern
时间窗: 14 days
Adherence will be assessed as the percent of days that each participant adheres to the 10-h TRE dietary pattern
次要结局
未报告次要终点
研究者
Amber Kleckner
Research Assistant Professor
University of Rochester