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OpenTrials
Completed

NCT Number: NCT04807959

Evaluation of 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.

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Key information

Conditions

Obesity Body Weight Cardiovascular Diseases Central Obesity Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hypertension Lipid Metabolism Disorders Metabolic Disease Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity, Abdominal Obesity, Morbid Obesity, Visceral Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes Vascular Diseases Visceral Obesity

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

20Lighter anti-obesity program

Other

A customized expert supervised 3-phase program including non-invasive proprietary nutritional, behavioral, and physiological components.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

20Lighter

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 19, 2021
Registry last updated
Mar 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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