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

NCT05456386 | Unknown

• 1 other identifier: BIORHYTHMSTUDYTBD
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

1. 1.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.
2. 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.
3. 3.Hypothesis: Compared to a wait list control, the CRAWL intervention will induce improvements in all metrics described above.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• The Circadian Rhythm Approach to Weight Loss (CRAWL) Intervention Weight Loss

  Change in recorded participant weight (kg).

  4 months

• The Circadian Rhythm Approach to Weight Loss (CRAWL) Intervention Daily Eating Opportunity Window

  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.

  4 months

Secondary Outcomes (2)

• The Circadian Rhythm Approach to Weight Loss (CRAWL) Intervention Total Sleep Time

  4 months

• The Circadian Rhythm Approach to Weight Loss (CRAWL) Intervention Sleep Architecture

  4 months

Study Arms (2)

The Circadian Rhythm Approach to Weight Loss (CRAWL) Intervention Arm

EXPERIMENTAL

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

Behavioral: The Circadian Rhythm Approach to Weight Loss (CRAWL)

Waitlist Control Arm

NO INTERVENTION

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.

Interventions

The Circadian Rhythm Approach to Weight Loss (CRAWL) BEHAVIORAL

The Circadian Rhythm Approach to Weight Loss (CRAWL) is a behavioral intervention that is designed to provide support for behavioral change to improve sleep and feeding parameters that will lead to sustainable weight loss.

The Circadian Rhythm Approach to Weight Loss (CRAWL) Intervention Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stephen Hutchison: lead

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MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Stephen M Hutchison, B.S.

CONTACT

15202031641; shutchison@email.arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Coordinator

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 13, 2022
• Study Start: August 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: July 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share