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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 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2022-07-14

No results posted yet for this study

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. 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.

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

Conditions

Interventions

BEHAVIORAL

The Circadian Rhythm Approach to Weight Loss (CRAWL)

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.

Sponsors & Collaborators

  • Stephen Hutchison

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2023-05-31
Completion
2023-05-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05456386 on ClinicalTrials.gov