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

Completed

• Conditions: Central Obesity; Hypertension; Type 2 Diabetes; Dyslipidemias; Visceral Obesity; Obesity, Morbid; Metabolic Disease; Obesity; Obesity, Visceral
• Interventions: Other: 20Lighter anti-obesity program

• Registration Number: NCT04807959
• Lead Sponsor: 20Lighter

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.

Study Timeline

• Study Start: 2016-10-27
• Primary Completion: 2018-10-01
• Study Completion: 2018-10-09
• Status Verified: 2021-03
• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-17
• Last Update Submitted: 2021-03-18
• Study First Posted: 2021-03-19
• Last Update Posted: 2021-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
20Lighter Program Participants	20Lighter anti-obesity program	All enrolled subjects will have completed a 20Lighter anti-obesity program prior to enrollment.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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.