Recruiting

Visceral Adiposity

Sponsor:

20Lighter

Code:

NCT05219240

Conditions

Obesity

Cardiovascular Diseases

Metabolic Syndrome

Metabolic Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

20Lighter Program

Study Details

Brief summary:

A retrospective review of body composition changes in patients who participate in a 9-week non-invasive intensive health care provider supervised weight loss program as an overall cohort and in sub-cohorts of interest.

Conditions

Obesity

Cardiovascular Diseases

Metabolic Syndrome

Metabolic Disease

Study ID

NCT05219240

Start date

Jan 1, 2020

Status verified date

Dec, 2022

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Men and women 18 years of age and older, who enroll in the weight loss program are eligible for inclusion of the data review.

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Current treatment of cancer
  • Major organ transplant with immunosuppressant medication,
  • Adult with a strict vegetarian diet,
  • Certain psychiatric conditions (schizophrenia, bipolar disorder, manic depression)
  • Adults with a BMI < 25.0 and no cardiovascular or metabolic comorbidities

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

Program participants

Interventions

20Lighter Program

Visceral Adiposity-Focused Anti-Obesity Telehealth Program

Primary outcome measure

  • Bodyweight Change [ Time Frame: Baseline to 90 days ]
  • Body Mass Index (BMI) Change [ Time Frame: Baseline to 90 days ]
  • Visceral Adiposity Change [ Time Frame: Baseline to 90 days ]
  • Body Fat % Change [ Time Frame: Baseline to 90 days ]
  • Lean Body Mass Change [ Time Frame: Baseline to 90 days ]
  • Intracellular Fluid % Change [ Time Frame: Baseline to 90 days ]

Central Contacts and Locations

Central contacts

Jessica Barnes, PhD

307-287-1555staff@20Lighter.com

Locations

20Lighter Telehealth Program

Recruiting

Little Rock, Arkansas, United States, 72205

20Lighter Telehealth Program

Recruiting

Cheyenne, Wyoming, United States, 82007

More Information

Sponsor

20Lighter

Last update posted

Dec 20, 2022

Last verified

Dec, 2022

Keywords

  • visceral adiposity
  • BMI
  • body composition
  • obesity
  • cardiovascular disease
  • metabolic syndrome
  • metabolic disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by 20Lighter on 2022-12-20.