Clinical trial NCT04807959: Evaluation of the Effectiveness of a Comprehensive Visceral Adiposity-Focused Anti-Obesity Program
Official title: A Retrospective Study to Evaluate the Effectiveness of a Comprehensive Visceral Adiposity-Focused Anti-Obesity Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Obesity, Morbid
Obesity, Visceral
Central Obesity
Metabolic Disease
Hypertension
Dyslipidemias
Type 2 Diabetes
Visceral Obesity
Lead sponsor: 20Lighter
Sponsor class: INDUSTRY
First posted: 2021-03-19
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults over the age of 18 with overweight or obesity, and may have other comoribid conditions including hypertension, type 2 diabetes, dyslipidemia, cardiovascular disease (CVD), nonalcoholic fatty liver disease, sleep apnea, and other related health issues.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction of Visceral Adiposity
timeFrame: Change from baseline to program completion (60 Days)
Secondary outcomes:
measure: Reduction of Body Weight
timeFrame: Change from baseline to program completion (60 Days)
measure: Reduction of Body Mass Index
timeFrame: Change from baseline to program completion (60 Days)
measure: Reduction of Body Fat
timeFrame: Change from baseline to program completion (60 Days)
measure: Increase of Intracellular Fluid
timeFrame: Change from baseline to program completion (60 Days)
Other outcomes:
Locations:
Study officials:
affiliation: 20Lighter
name: Jessica Barnes, PhD
role: STUDY_CHAIR
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