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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04807959
Recruitment Status : Completed
First Posted : March 19, 2021
Last Update Posted : March 22, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Obesity Obesity, Morbid Obesity, Visceral Central Obesity Metabolic Disease Hypertension Dyslipidemias Type 2 Diabetes Visceral Obesity Other: 20Lighter anti-obesity program

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.

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Study Type : Observational
Actual Enrollment : 2200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Study to Evaluate the Effectiveness of a Comprehensive Visceral Adiposity-Focused Anti-Obesity Program
Actual Study Start Date : October 27, 2016
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : October 9, 2018

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04807959


Sponsors and Collaborators
20Lighter
Investigators
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Study Chair: Jessica Barnes, PhD 20Lighter
Publications:
Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ, Jordan HS, Kendall KA, Lux LJ, Mentor-Marcel R, Morgan LC, Trisolini MG, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. Circulation. 2014 Jun 24;129(25 Suppl 2):S102-38. doi: 10.1161/01.cir.0000437739.71477.ee. Epub 2013 Nov 12. Erratum in: Circulation. 2014 Jun 24;129(25 Suppl 2):S139-40.

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Responsible Party: 20Lighter
ClinicalTrials.gov Identifier: NCT04807959    
Other Study ID Numbers: 2016-443A
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Dyslipidemias
Metabolic Diseases
Obesity, Morbid
Obesity, Abdominal
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Lipid Metabolism Disorders