Central Obesity, Dyslipidemias, Hypertension, Metabolic Disease, Obesity, Obesity, Morbid, Obesity, Visceral, Type 2 Diabetes, Visceral Obesity
Conditions
Brief summary
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
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.
Interventions
OTHER20Lighter anti-obesity program
A customized expert supervised 3-phase program including non-invasive proprietary nutritional, behavioral, and physiological components.
Sponsors
20Lighter
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Visceral Adiposity | Change from baseline to program completion (60 Days) | % 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Body Weight | Change from baseline to program completion (60 Days) | % reduction of body weight measured via an FDA-cleared Class 2 medical device with Bioelectrical Impedance Analysis (BIA) via bipolar foot electrodes. |
| Reduction of Body Mass Index | Change from baseline to program completion (60 Days) | % reduction of body mass index measured via an FDA-cleared Class 2 medical device with Bioelectrical Impedance Analysis (BIA) via bipolar foot electrodes. |
| Reduction of Body Fat | Change from baseline to program completion (60 Days) | % reduction of body fat measured via an FDA-cleared Class 2 medical device with Bioelectrical Impedance Analysis (BIA) via bipolar foot electrodes. |
| Increase of Intracellular Fluid | Change from baseline to program completion (60 Days) | % 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. |
Outcome results
None listed