Changes in 24-hour Activity Cycle Behaviors During a Time-Restricted Eating Intervention in College-Aged Women

Официальное название

DAWGS in Time-Restricted Eating and Activity Trends (DAWG-TREAT)

Обзор

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.

Вмешательства

• Поведенческое Time Restricted Eating
  Participants randomized to the TRE group will self-select a consistent 8-hour daily eating window that aligns with their usual schedule. Participants will be instructed to consume all caloric intake within this 8-hour window and abstain from caloric intake outside of the window for 3 weeks. Participants will be instructed not to intentionally modify diet quality or caloric intake during the intervention period, aside from restricting meal timing. Consumption of water and non-caloric beverages (
• Поведенческое Control
  The control group in this study will receive a basic nutrition education. This group will follow normal eating patterns for 3 weeks.

Первичные конечные точки

• 24-Hour Activity Cycle [Срок оценки: From enrollment to the end of study participation (4 weeks)]

Вторичные конечные точки (2)

• Sleep quality: Objective [Срок оценки: From enrollment to the end of study participation (4 weeks)]
• Sleep quality: Subjective [Срок оценки: At the beginnning of the study and at the end of study]

Критерии участия

Критерии включения

• Female undergraduate and graduate students
• Enrolled full-time at University of Georgia
• Aged 18-26 years

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Physical Activity Measurement Lab — Athens

Идентификаторы

NCT: NCT07520786 · PROJECT00012891

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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