DAWGS in Time-Restricted Eating and Activity Trends (DAWG-TREAT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 24-Hour Activity Cycle
研究概览
简要总结
Time-restricted Eating (TRE) is a dietary approach that limits food intake to 4 - 12-hour windows without intentionally altering diet quality. TRE has several benefits including modest reductions in body weight and fat mass, improved glucose control, and reduced inflammatory markers. While research supports the metabolic and weight related benefits of TRE, there is limited evidence of its effects on physical activity (PA), sedentary behavior (SB) and sleep - the core components of 24-hour Activity Cycle (24-HAC), which is a holistic framework that integrates the three health-related activities. TRE research has largely focused on clinical populations, leaving its feasibility and adherence in healthy younger adults understudied. Within this group, college students' misaligned circadian rhythms and unpredictable schedules may make adherence to TRE challenging, highlighting the need for research on its practicality in this group. These outcomes are also particularly important to investigate in women, considering that SB is more prevalent among college-aged women (69%) compared to men (46%). To address these issues, we will conduct a three-week intervention to study the effects of TRE on the 24-HAC outcomes. College aged women will be screened and enrolled, then assigned to either a control or TRE group. Participants in the TRE group will self-select the timing of their 8-hour eating window which they will maintain throughout the study (with compliance on at least six days per week needed to be considered adherent). The control group will receive a basic nutrition education at the start of the study and will have no restriction on eating times. 24 HAC behaviors will be measured continuously for one-week of baseline measurement and throughout the intervention by wrist-worn ActiGraph GT9X monitors. Participants will also record the timing of their first and last meal each day and receive periodic reminders to report their hunger and satiety ratings using visual analog scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 26 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female undergraduate and graduate students
- •Enrolled full-time at University of Georgia
- •Aged 18-26 years
排除标准
- •having one of the following chronic diseases that maybe impacted by the diet changes: type 1 and 2 diabetes mellitus, cancer, cardiovascular diseases, hypertension, thyroid dysfunction, hepatic/renal impairment, inflammatory bowel disease and other gastrointestinal diseases,
- •report use of nicotine, thyroid medications, antidepressants, or anti-anxiety medications, melatonin
- •having clinically diagnosed sleep disorders
- •alcohol intake exceeds two drinks per day
- •clinically diagnosed or undiagnosed eating disorders
- •division-1 student athletes
- •pregnant or lactating or plan on getting pregnant within 6 months
- •report major ambulatory disorders,
- •recently (within the past two weeks) engaged in caloric restriction, timing-based dietary changes, weight loss regimens, or adhered to specialized diets such as ketogenic or paleo diets,
- •required to take medication with food, as these factors may interfere with sleep and physical activity outcomes or pose risks to participant health during restricted eating protocols. Students whose habitual eating time windows are <10 hours will also not be eligible.
研究组 & 干预措施
Time Restricted Eating (TRE)
8-hour (self-selcted) TRE
干预措施: Time Restricted Eating (Behavioral)
Control
Normal eating
干预措施: Control (Behavioral)
结局指标
主要结局
24-Hour Activity Cycle
时间窗: From enrollment to the end of study participation (4 weeks)
Physical activity (PA), sedentary behavior (SB) and sleep duration, the three main components of 24-Hour Activity Cycle will be measured using an ActiGraph GT9X (wrist watch style activity monitor) worn continuously on the non-dominant wrist during baseline and intervention weeks. ActiGraph accelerometers are widely used for measuring PA intensity and SB time, energy expenditure and sleep. Non-sedentary time will be used as a metric to measure time spent in PA. The Choi 90-minute algorithm will be used to identify ActiGraph non-wear times. Participants will report their sleep time and wake time in the Daily Survey. Total sleep time will be calculated as the difference in their self-reported sleep and wake times.
次要结局
- Sleep quality: Objective(From enrollment to the end of study participation (4 weeks))
- Sleep quality: Subjective(At the beginnning of the study and at the end of study)
研究者
Michael Schmidt
Professor
University of Georgia