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

March 18, 2021 updated by: 20Lighter

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

2200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of Visceral Adiposity
Time Frame: 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.
Change from baseline to program completion (60 Days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of Body Weight
Time Frame: 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.
Change from baseline to program completion (60 Days)
Reduction of Body Mass Index
Time Frame: 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.
Change from baseline to program completion (60 Days)
Reduction of Body Fat
Time Frame: 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.
Change from baseline to program completion (60 Days)
Increase of Intracellular Fluid
Time Frame: 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.
Change from baseline to program completion (60 Days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

20Lighter

Investigators

  • Study Chair: Jessica Barnes, PhD, 20Lighter

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2016

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 9, 2018

Study Registration Dates

First Submitted

March 17, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 19, 2021

Study Record Updates

Last Update Posted (Actual)

March 22, 2021

Last Update Submitted That Met QC Criteria

March 18, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-443A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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