Evaluation of Body Composition Improvement With Visceral Adiposity-Focused Anti-Obesity Telehealth Program

Recruiting

• Conditions: Metabolic Syndrome; Cardiovascular Diseases; Metabolic Disease; Obesity
• Interventions: Other: 20Lighter Program

• Registration Number: NCT05219240
• Lead Sponsor: 20Lighter

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2022-01-21
• Study First Submitted QC: 2022-01-21
• Study First Posted: 2022-02-02
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-18
• Last Update Posted: 2022-12-20
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Program participants	20Lighter Program	-

Primary Outcome Measures

Name	Time	Method
Bodyweight Change	Baseline to 90 days	Change in bodyweight
Body Mass Index (BMI) Change	Baseline to 90 days	Change in Body Mass Index (BMI)
Visceral Adiposity Change	Baseline to 90 days	Change in Visceral Adiposity
Body Fat % Change	Baseline to 90 days	Change in Body Fat %
Lean Body Mass Change	Baseline to 90 days	Change in Lean Body Mass
Intracellular Fluid % Change	Baseline to 90 days	Change in Intracellular Fluid %

Trial Locations

Locations (1)

20Lighter Telehealth Program; 🇺🇸 Cheyenne, Wyoming, United States