Proof-of-Concept of Time-Restricted Eating as a Novel Lifestyle Intervention for Breast Cancer Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 178
- 试验地点
- 2
- 主要终点
- Adherence to TRE for the 16-week intervention
研究概览
简要总结
This study will evaluate the implementation and effectiveness of free-living TRE on biological and behavioural breast cancer risk factors.
详细描述
TRE is an eating pattern where individuals consume ad libitum energy intake within a set window of time, commonly 8 hours, which induces a fasting window of 16 hours per day (i.e., 16:8 TRE). TRE is a simple and accessible lifestyle intervention with high adherence potential that may target both biological and behavioural mechanisms of breast cancer risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •No cancer history
- •≥50 years old
- •Have metabolic dysfunction (defined as self-reported diagnosis of pre-diabetes, type 2 diabetes, or at least moderate Canadian diabetes risk (CANRISK) score)
- •Access to an Ontario Lifelabs location
- •Owns a smartphone with Bluetooth capability with Apple or Android operating system
排除标准
- •Type 1 diabetes
- •Taking exogenous insulin, sulfonylureas, or GLP-1 receptor agonists
- •Self-reported history of an eating disorder
- •BMI <18.5 kg/m
- •Working night or rotating shifts
- •Eating window <12 hours or consistently eating less than 3 meals/day in the past 3 months
- •Major dietary changes within the past 3 months (i.e. calorie counting, ketogenic diet)
研究组 & 干预措施
Standardized TRE protocol + External Support
Participants will be asked to follow a standardized 16:8 TRE protocol with an 11 am to 7 pm eating window for 16 weeks. Participants receive support to follow the TRE intervention from the study team which will include an initial consultation with a registered dietitian and ongoing tailored feedback via brief support calls from study staff at weeks 1, 3, 6, and 12.
干预措施: Standardized TRE Protocol (Behavioral)
Standardized TRE protocol + External Support
Participants will be asked to follow a standardized 16:8 TRE protocol with an 11 am to 7 pm eating window for 16 weeks. Participants receive support to follow the TRE intervention from the study team which will include an initial consultation with a registered dietitian and ongoing tailored feedback via brief support calls from study staff at weeks 1, 3, 6, and 12.
干预措施: External Support for TRE (Behavioral)
Standardized TRE protocol + Peer Support
Participants will be asked to follow a standardized 16:8 TRE protocol with an 11 am to 7 pm eating window for 16 weeks. Each participant will be matched with another participant in the same group to provide peer-based support to adhere to TRE. Study staff will introduce pairs and provide an introduction to TRE and then pairs will meet by phone/video at weeks 1, 3, 6, and 12 at a minimum, with additional contact encouraged.
干预措施: Standardized TRE Protocol (Behavioral)
Standardized TRE protocol + Peer Support
Participants will be asked to follow a standardized 16:8 TRE protocol with an 11 am to 7 pm eating window for 16 weeks. Each participant will be matched with another participant in the same group to provide peer-based support to adhere to TRE. Study staff will introduce pairs and provide an introduction to TRE and then pairs will meet by phone/video at weeks 1, 3, 6, and 12 at a minimum, with additional contact encouraged.
干预措施: Peer Support for TRE (Behavioral)
Personalized TRE protocol + External Support
Participants will be asked to follow TRE for 16 weeks with a protocol that is personalized to their preferences within the following pre-specified rules: 1) 8-10 hour eating window; 2) self-selected eating window start time as long as it ends ≥3h before bedtime; 3) if days off are required, aim to do so after following TRE for ≥5 successive days each week. Participants receive support to follow the TRE intervention from the study team which will include an initial consultation with a registered dietitian and ongoing tailored feedback via brief support calls from study staff at weeks 1, 3, 6, and 12.
干预措施: Personalized TRE Protocol (Behavioral)
Personalized TRE protocol + External Support
Participants will be asked to follow TRE for 16 weeks with a protocol that is personalized to their preferences within the following pre-specified rules: 1) 8-10 hour eating window; 2) self-selected eating window start time as long as it ends ≥3h before bedtime; 3) if days off are required, aim to do so after following TRE for ≥5 successive days each week. Participants receive support to follow the TRE intervention from the study team which will include an initial consultation with a registered dietitian and ongoing tailored feedback via brief support calls from study staff at weeks 1, 3, 6, and 12.
干预措施: External Support for TRE (Behavioral)
Personalized TRE protocol + Peer Support
Participants will be asked to follow TRE for 16 weeks with a protocol that is personalized to their preferences within the following pre-specified rules: 1) 8-10 hour eating window; 2) self-selected eating window start time as long as it ends ≥3h before bedtime; 3) if days off are required, aim to do so after following TRE for ≥5 successive days each week. Each participant will be matched with another participant in the same group to provide peer-based support to adhere to TRE. Study staff will introduce pairs and provide an introduction to TRE and then pairs will meet by phone/video at weeks 1, 3, 6, and 12 at a minimum, with additional contact encouraged.
干预措施: Personalized TRE Protocol (Behavioral)
Personalized TRE protocol + Peer Support
Participants will be asked to follow TRE for 16 weeks with a protocol that is personalized to their preferences within the following pre-specified rules: 1) 8-10 hour eating window; 2) self-selected eating window start time as long as it ends ≥3h before bedtime; 3) if days off are required, aim to do so after following TRE for ≥5 successive days each week. Each participant will be matched with another participant in the same group to provide peer-based support to adhere to TRE. Study staff will introduce pairs and provide an introduction to TRE and then pairs will meet by phone/video at weeks 1, 3, 6, and 12 at a minimum, with additional contact encouraged.
干预措施: Peer Support for TRE (Behavioral)
Control Group
Participants will be asked to maintain their usual diet and physical activity patterns for 16 weeks. They will receive the same number and timing of calls from study staff as the other groups (at randomization, 1, 3, 6, 12 weeks).
结局指标
主要结局
Adherence to TRE for the 16-week intervention
时间窗: 16-week average
Assessed daily through twice daily automated text messages asking participants to respond with what time they started and stopped eating that day.
Hemoglobin A1c
时间窗: 16 Weeks
Collected via venipuncture
次要结局
- 10-year cardiovascular disease risk(16 Weeks)
- Metabolic syndrome (NCEP/ATP III criteria)(16 Weeks)
- Metabolic syndrome z-score(16 Weeks)
- Lipid profile(16 Weeks)
- Body weight(16 Weeks)
- Cost of intervention delivery(16 Weeks)
- TRE Adverse Events(16 Weeks)
- Free-living glucose control(16 Weeks)
- C-Reactive Protein(16 Weeks)
- HOMA-IR(16 Weeks)
- Waist circumference(16 weeks)
- Blood Pressure(16 Weeks)
- Alanine Aminotransferase(16 Weeks)
- TRE acceptability and appropriateness(16 Weeks)
- Sleep duration(16 Weeks)
- Sedentary time(16 Weeks)
- Physical activity(16 Weeks)
- TRE Adoption(16 Weeks)
- TRE Sustainability(1, 2, 3, and 4 months post intervention period)
- Health-related quality of life(16 Weeks)
研究者
Amy Kirkham
Amy Kirkham, Assistant Professor
University of Toronto