Evaluation of the Effectiveness of a Comprehensive Visceral Adiposity-Focused Anti-Obesity Program

Study Overview
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Brief Summary
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A retrospective review of body composition outcomes of participants of a comprehensive visceral-fat focused anti-obesity program. Data from approximately 2000-2500 participants are expected to be included in the study.

Detailed Description
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This is a retrospective, multi-center clinical study to evaluate the efficacy of the 20Lighter comprehensive anti-obesity program in reducing body composition measures including body weight, body fat, visceral adiposity, intracellular fluid, and other metrics of interest. Anecdotal evidence on reductions of prescription medication, chronic health issues, and improvements in quality of life will be gauged via review of patient assessment forms and surveys.

Official Title
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A Retrospective Study to Evaluate the Effectiveness of a Comprehensive Visceral Adiposity-Focused Anti-Obesity Program

Conditions
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Obesity, Obesity, Morbid, Obesity, Visceral, Central Obesity, Metabolic Disease, Hypertension, Dyslipidemias, Type 2 Diabetes, Visceral Obesity

Intervention / Treatment
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* Other: 20Lighter anti-obesity program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI >25 ability to stand on platform for body composition analysis Exclusion Criteria: Pregnant at time of enrollment Breastfeeding at time of enrollment Undergoing treatment for cancer at time of enrollment History of major organ transplant with immunosuppressant medication Over the 70 years of age with diagnosis of three cardiovascular comorbidities at time of enrollment Adult with a vegetarian diet Diagnosis of psychiatric conditions including: schizophrenia, bipolar disorder, manic depression

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 20Lighter Program Participants<br>All enrolled subjects will have completed a 20Lighter anti-obesity program prior to enrollment. | Other: 20Lighter anti-obesity program<br>* A customized expert supervised 3-phase program including non-invasive proprietary nutritional, behavioral, and physiological components.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of Visceral Adiposity | % reduction of visceral adiposity (as measured by visceral fat rating) measured via an FDA-cleared Class 2 medical device with Bioelectrical Impedance Analysis (BIA) via bipolar foot electrodes. | Change from baseline to program completion (60 Days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of Body Weight | % reduction of body weight measured via an FDA-cleared Class 2 medical device with Bioelectrical Impedance Analysis (BIA) via bipolar foot electrodes. | Change from baseline to program completion (60 Days) | 
| Reduction of Body Mass Index | % reduction of body mass index measured via an FDA-cleared Class 2 medical device with Bioelectrical Impedance Analysis (BIA) via bipolar foot electrodes. | Change from baseline to program completion (60 Days) | 
| Reduction of Body Fat | % reduction of body fat measured via an FDA-cleared Class 2 medical device with Bioelectrical Impedance Analysis (BIA) via bipolar foot electrodes. | Change from baseline to program completion (60 Days) | 
| Increase of Intracellular Fluid | % increase of intracellular fluid (as measured by body water %) measured via an FDA-cleared Class 2 medical device with Bioelectrical Impedance Analysis (BIA) via bipolar foot electrodes. | Change from baseline to program completion (60 Days) |