- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07282119
Can EmeraldLED Reshape Your Body With Continued Use?
Study Overview
Detailed Description
This remotely administered decentralized trial is designed to rigorously explore the efficacy of green light therapy on body composition and overall well-being, under the leadership of Ryan, the CEO of beem® Light Sauna. With over 30 years of experience in the wellness industry, Ryan has observed firsthand the surge in popularity of green light therapy, accompanied by a myriad of claims regarding its benefits. Despite widespread anecdotal evidence suggesting that green light therapy can aid in weight loss and improve mood, there remains a significant gap in scientific research to support these claims conclusively. This study aims to bridge this gap by providing empirical evidence on the effects of green light therapy.
The objective of this study is to empower participants with knowledge about how green light exposure might influence their weight management efforts and overall sense of well-being. By participating in this remote trial, individuals will receive personalized data regarding changes in their body composition and mood, following a structured regimen of green light therapy. This personalized feedback will enable participants to make informed decisions about incorporating green light therapy into their health and wellness routines.
The significance of this study lies in its potential to challenge and possibly redefine existing weight management strategies. By collecting and analyzing data on how green light therapy affects individuals, this study seeks to provide insights that could lead to new, innovative approaches to health and wellness. While acknowledging the limitations of this initial trial, including the necessity for further comprehensive research, the findings could serve as a valuable foundation for future studies and health innovations.
In sum, this decentralized trial represents a critical step towards demystifying the effects of green light therapy on body composition and mood enhancement. Through rigorous scientific investigation, this study aims to validate or debunk the claims surrounding green light therapy, thereby contributing to the broader understanding of its potential benefits and limitations. Participants' involvement is not just a journey towards personal health enlightenment but also a contribution to the global conversation on effective, science-backed wellness strategies.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Matthew Amsden
- Phone Number: 646-679-2479
- Email: help@efforia.com
Study Locations
-
-
New York
-
New York, New York, United States, 10003
- Recruiting
- Efforia
-
Contact:
- Matthew Amsden
- Phone Number: (646) 679-2479
- Email: help@efforia.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Can read and understand English.
- US resident.
- Willing and able to follow the requirements of the protocol.
Exclusion Criteria:
- Individuals with eye conditions
- Individuals not active with EmeraldLED
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single arm where participants act as their own control
Single Arm observational where participants act as their own control
|
This device is a customizable, multi-wavelength therapeutic system designed for individualized cosmetic treatments. It features an easy-to-use interface with preprogrammed treatment categories, a wide pulsing frequency range from 1 to 15,000 Hz, and independent wavelength control for precise protocol tailoring. The system delivers five wavelengths-450 nm, 525 nm, 650 nm, 810 nm, and 980 nm-with an output power of 3,325 W and irradiance up to 119 mW/cm². The green light EmeraldLED therapy provided in this study is set at 525 nm. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Image and Self-Perception Survey
Time Frame: Change from baseline (Day 1-3) in body image and self-perception at 4 weeks after the start of the intervention (Day 27-33).
|
This survey aims to understand an individual's perception of their body, attractiveness, and physical functionality.
It contains multiple-choice questions with five options ranging from 'Strongly Disagree' to 'Strongly Agree'.
The questions are divided into three categories: Body Satisfaction, Attractiveness Evaluation, and Physical Functionality Awareness.
|
Change from baseline (Day 1-3) in body image and self-perception at 4 weeks after the start of the intervention (Day 27-33).
|
|
Body Composition Measurement Form
Time Frame: Change from baseline (Day 1-3) in body measurements at 4 weeks after the start of the intervention (Day 27-33).
|
The Body Composition Measurement Form is specifically crafted to accurately track changes in body measurements relevant to individuals engaged in weight loss or bodybuilding.
This form allows for the consistent recording of key physical metrics across various body parts, facilitating the evaluation of fitness progress.
By using this form, individuals can obtain a clear picture of the physical changes resulting from their exercise routines and nutritional choices.
Each measurement is to be recorded in centimeters to maintain uniformity and precision.
|
Change from baseline (Day 1-3) in body measurements at 4 weeks after the start of the intervention (Day 27-33).
|
|
Quality of Life and Health Survey
Time Frame: Change from baseline (Day 1-3) in quality of life and health perceptions at 4 weeks after the start of the intervention (Day 27-33).
|
This survey asks about your feelings towards your quality of life, health, and various areas of your life.
It covers your experiences and feelings in the past four weeks.
Please choose the answer that appears most appropriate.
|
Change from baseline (Day 1-3) in quality of life and health perceptions at 4 weeks after the start of the intervention (Day 27-33).
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 44804
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.