Clinical trial NCT05219240: Evaluation of Body Composition Improvement With Visceral Adiposity-Focused Anti-Obesity Telehealth Program
Official title: Evaluation of Body Composition Improvement With Visceral Adiposity-Focused Anti-Obesity Telehealth Program
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Cardiovascular Diseases
Metabolic Syndrome
Metabolic Disease
Keywords: visceral adiposity
BMI
body composition
obesity
cardiovascular disease
metabolic syndrome
metabolic disease
Lead sponsor: 20Lighter
Sponsor class: INDUSTRY
First posted: 2022-02-02
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20Lighter program participants

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.


Eligibility criteria: 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

Primary outcomes:
measure: Bodyweight Change
timeFrame: Baseline to 90 days
measure: Body Mass Index (BMI) Change
timeFrame: Baseline to 90 days
measure: Visceral Adiposity Change
timeFrame: Baseline to 90 days
measure: Body Fat % Change
timeFrame: Baseline to 90 days
measure: Lean Body Mass Change
timeFrame: Baseline to 90 days
measure: Intracellular Fluid % Change
timeFrame: Baseline to 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: 20Lighter Telehealth Program
state: Arkansas
city: Cheyenne
country: United States
facility: 20Lighter Telehealth Program
state: Wyoming
Study officials:
affiliation: 20Lighter
name: Jessica Barnes, PhD
role: PRINCIPAL_INVESTIGATOR
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