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

December 18, 2022 updated by: Jessica W. Barnes, PhD, 20Lighter
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • 20Lighter Telehealth Program
        • Contact:
          • Jessica Barnes, PhD
    • Wyoming
      • Cheyenne, Wyoming, United States, 82007
        • Recruiting
        • 20Lighter Telehealth Program
        • Contact:
          • Jessica Barnes, PhD

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

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

20Lighter program participants

Description

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 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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Program participants
Other: 20Lighter Program
Visceral Adiposity-Focused Anti-Obesity Telehealth Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bodyweight Change
Time Frame: Baseline to 90 days
Change in bodyweight
Baseline to 90 days
Body Mass Index (BMI) Change
Time Frame: Baseline to 90 days
Change in Body Mass Index (BMI)
Baseline to 90 days
Visceral Adiposity Change
Time Frame: Baseline to 90 days
Change in Visceral Adiposity
Baseline to 90 days
Body Fat % Change
Time Frame: Baseline to 90 days
Change in Body Fat %
Baseline to 90 days
Lean Body Mass Change
Time Frame: Baseline to 90 days
Change in Lean Body Mass
Baseline to 90 days
Intracellular Fluid % Change
Time Frame: Baseline to 90 days
Change in Intracellular Fluid %
Baseline to 90 days

Collaborators and Investigators

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

Sponsor

20Lighter

Investigators

  • Principal Investigator: 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)

January 1, 2020

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

January 21, 2022

First Submitted That Met QC Criteria

January 21, 2022

First Posted (Actual)

February 2, 2022

Study Record Updates

Last Update Posted (Estimate)

December 20, 2022

Last Update Submitted That Met QC Criteria

December 18, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20L02

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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