The BioRythm Guided Weight Loss Study Will Test a Novel Behavioral Health Intervention Combined With Fitbit Technology Monitoring in Obese Individuals to Determine if it Promotes Weight Loss, Improves Objective Measures of Sleep Health, and Aids in Developing a Consistent Mealtime Routine
Obesity
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
The Circadian Rhythm Approach to Weight Loss (CRAWL) Intervention Arm
Waitlist Control 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
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.