BioRhythm Health Coaching and Sleep Monitoring Program for Weight Loss
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 65
- 主要终点
- The Circadian Rhythm Approach to Weight Loss (CRAWL) Intervention Weight Loss
研究概览
简要总结
The BioRhythm study will test a novel behavioral health intervention that utilizes personalized behavioral health counseling as well as sleep and activity data obtained via wearable technology to promote weight loss in obese individuals.
- Determine whether the use of the The Circadian Rhythm Approach to Weight Loss (CRAWL) intervention results in improvements in weight loss and a reduction in mean daily eating opportunity window.
a. Hypothesis: Compared to a wait list control, the CRAWL intervention will induce greater changes in weight loss and body mass index and mean daily eating opportunity window. 2. Establish whether use of the CRAWL intervention results in changes in objectively estimated circadian rhythm, activity levels, sleep duration, sleep architecture, and sleep timing.
- Hypothesis: Compared to a wait list control, the CRAWL intervention will induce improvements in all metrics described above.
详细描述
Subjects interested in the participation of this study will be directed to a screening questionnaire to determine study eligibility. Eligible participants will be contacted by the study coordinator to schedule a virtual meeting to complete the informed consent procedure.
Upon the completion of the informed consent procedure, subjects will be mailed a Fitbit Versa 2 and instructions for use. Subjects will be asked to contact the study team when they receive their devices to schedule a virtual teleconference to walk them through detailed use instructions as well as data uploading procedures on their mobile device. The study team will be able to address any concerns or questions at this time. Subjects will also be reminded that they may contact the study team at any time if they have questions or concerns.
The Fitbit Vera 2 is a wristband that includes sensors for heart rate and accelerometry. From these sensors, data such as resting heart rate, activity patterns, and sleep continuity and architecture can be extracted. These wristbands are worn continuously and charged every 7 days. Data are synced to an app that the subject will install on their mobile device. The app will give health tips for the patient to improve sleep, activity, and nutrition and then send monitoring information to the study team.
Prior to using the device, the subject will have a pre-scheduled consultation with a designated health aide via virtual conference to introduce the weight loss program. The health aide will also complete a structured interview during this consultation which will include a series of questionnaires.
After subjects have been oriented to the devices and have completed their preliminary intake questionnaires and medical history, they will begin the following protocol:
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between the ages of 18 - 75 years old
- •Able to read and write fluently in English or Spanish
- •Access to a mobile device for video calls, online questionnaires, syncing devices, and communication with study staff
- •Access to a residential mailing address for shipping study materials
- •Body Mass Index (BMI) ≥ 30
- •Self-report that they have a problem with their weight that they wish to improve
- •Must be able to participate in mild to moderate physical activity
- •Access to a mechanical or digital scale
排除标准
- •Have a severe, untreated sleep disorder (e.g., Obstructive Sleep Apnea (OSA), Restless Leg Syndrome (RLS), insomnia, narcolepsy)
- •Patients who are unable to participate in prolonged fasting periods such as insulin dependent diabetics.
- •Have a medical condition that would interfere with their ability to complete all study procedures or would render measurements invalid (e.g., some autoimmune conditions, cardiac conditions, endocrine conditions, or chronic pain conditions)
- •Unable to achieve a regular sleep schedule, where bed and wake times are kept within a 2-hour window 7 days per week
- •Unable to maintain a regular sleep schedule during the night, beginning no earlier than 9pm and ending no later than 10am
- •Have not engaged in shift work for the past month, and will refrain from shift work during the study
- •Are unable to restrict alcohol consumption to no more than 2 drinks within 4 hours of sleep
- •Are unable to restrict caffeine use to no coffee or caffeinated beverages after 12pm during the study
- •Regularly smoke or use other tobacco products
- •Are unable to restrict cannabis products (e.g., marijuana) or cannabis-derived medicinal products (e.g., Marinol) within 4 hours of sleep
- •Are pregnant
- •Are a full-time caregiver to an individual that requires attending during the evening and night
- •Physically disabled or confined to a bed, wheelchair, or walker.
- •Presence of a diagnosed eating disorder
- •Currently use prescription or over-the-counter appetite suppressants or other prescription drugs that may interfere with appetite (e.g., Adderall)
- •Are diagnosed with bipolar disorder, schizophrenia, or untreated depression (PHQ-9 > 15).
研究组 & 干预措施
The Circadian Rhythm Approach to Weight Loss (CRAWL) Intervention Arm
The Circadian Rhythm Approach to Weight Loss (CRAWL) intervention subjects will continuously wear their Fitbit Versa 2 (aside from periodic charging periods) and participate in the pre-scheduled CRAWL sessions. Every week, subjects will complete a sleep diary, which assesses subject's time in bed, sleep latency, awakenings, wake after sleep onset, awakening time, overall sleep quality, overall refreshed rating, naps, exercise, energy level and mood. Subjects are to ensure their Fitbit is sufficiently charged every night before bed and they are to wear their Fitbit continuously throughout the night. Subjects will weigh themselves using their home scale each week prior to exercise, taking a shower or eating breakfast. They will record their weight in their provided weight tracking sheet
干预措施: The Circadian Rhythm Approach to Weight Loss (CRAWL) (Behavioral)
Waitlist Control Arm
Waitlist control subjects will follow the same protocol outlined above for 16 weeks minus the scheduled CRAWL sessions. When the initial treatment arm has completed their 16 weeks of group sessions, the waitlist control group will begin their CRAWL sessions.
结局指标
主要结局
The Circadian Rhythm Approach to Weight Loss (CRAWL) Intervention Weight Loss
时间窗: 4 months
Change in recorded participant weight (kg).
The Circadian Rhythm Approach to Weight Loss (CRAWL) Intervention Daily Eating Opportunity Window
时间窗: 4 months
Change in mean daily eating opportunity window defined by the elapsed time between the consumption of the first meal of the day and the last meal of the day.
次要结局
- The Circadian Rhythm Approach to Weight Loss (CRAWL) Intervention Sleep Architecture(4 months)
- The Circadian Rhythm Approach to Weight Loss (CRAWL) Intervention Total Sleep Time(4 months)
研究者
Stephen Hutchison
Research Coordinator
University of Arizona