Overnight Fasting After Completion of Therapy: The OnFACT Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Participation completion
研究概览
简要总结
The purpose of this study is to test whether regularly not eating for at least 14 hours overnight ("intermittent fasting") is feasible and can improve blood sugar.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Body mass index is ≥ 18.5 kg/m^2
- •History of treatment for cancer or related illness diagnosed at ≤ 25 years old
- •Off cytotoxic therapy for primary cancer ≥ 2 years
- •Not receiving cytotoxic therapy (chemotherapy, external beam radiation therapy) at the time of study enrollment
- •History of radiation to the chest, abdomen or total body
- •Current age ≥18 years
- •English-speaking
- •Personal phone with SMS text messaging capability
- •Willingness to wear an mHealth device, such as a FitBit, for two 7-day periods
- •Able to perform all study requirements
排除标准
- •Use of any antidiabetic, weight loss, or appetite control medication
- •Use of any other medication that could impact dietary intake, such as prednisone
- •Currently fasts 12 hours or more by self-report
- •Unable to fast due to medical reason such as pregnancy
研究组 & 干预措施
prolonged overnight fasting
Participants randomized to the fasting arm will be instructed on how to use the SMS texting app to indicate the beginning and end of the nightly fast. In the first 2-4 weeks following the first overnight fast, intervention participants will complete three phone calls with study staff trained in motivational interviewing. These calls will be used to reinforce the prolonged overnight fasting instructions, identify barriers to prolonged overnight fasting, and support successes where they have occurred.
干预措施: prolonged overnight fasting (Other)
usual care
Participants randomized to the usual care arm will be instructed to eat a heart-healthy diet and exercise for at least 30 minutes five days a week, which is usual counseling in our clinics.
干预措施: usual care (Other)
结局指标
主要结局
Participation completion
时间窗: 6 months
Proportion of registered participants who successfully complete the 6-month intervention
次要结局
- measure of glucose metabolism(6 months)