Obesity & Overweight · Observational Study

Redefining Evaluation of Adiposity and Leanness: Broadening Objective Diagnostics for Obesity

ClinicalTrials.gov · August 20, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a clinical trial registry record describing a planned observational study to evaluate agreement between body composition measurement modalities (BIA, 3D optical imaging, anthropometry, DXA, MRI, blood tests) against reference standards. No results are reported in this registry record; the study is currently recruiting and has not yet generated outcome data.

What was studied

Observational. Obesity & Overweight; age from 18 Years. Intervention: Body composition assessment via bioelectrical impedance analysis (BIA), 3-dimensional optical imaging (3DO), manual anthropometry, dual-energy X-ray absorptiometry (DXA), magnetic resonance imaging (MRI), and blood tests.. Compared with: Reference modality for body composition (not specified in registry record).. n = 300. 3 sites: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is an ongoing observational registry study with no reported results; it describes a planned validation effort across multiple body composition modalities with an estimated sample of 300 participants.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measures: Modality-reference agreement for total fat mass (kg) (assessed at 4 Weeks); Modality-reference agreement for fat-free mass (kg) (assessed at 4 Weeks); Modality-reference agreement for percent body fat (%) (assessed at 4 Weeks); Modality-reference agreement for visceral adipose tissue (VAT; kg or volume) (assessed at 4 Weeks)

DesignObservational

PopulationObesity & Overweight; age from 18 Years

Sample size300

InterventionBody composition assessment via bioelectrical impedance analysis (BIA), 3-dimensional optical imaging (3DO), manual anthropometry, dual-energy X-ray absorptiometry (DXA), magnetic resonance imaging (MRI), and blood tests.

ComparatorReference modality for body composition (not specified in registry record).

Setting3 sites: United States

Reported figures

Quoted from the source exactly as published.

Planned sample size300

Primary outcome: total fat mass agreementModality-reference agreement at 4 weeks

Primary outcome: fat-free mass agreementModality-reference agreement at 4 weeks

Primary outcome: percent body fat agreementModality-reference agreement at 4 weeks

Primary outcome: visceral adipose tissue agreementModality-reference agreement (kg or volume) at 4 weeks

Caveats

This registry record reports no results; study is actively recruiting and outcome data are not yet available.
Estimated enrollment of 300; actual sample size at analysis is unknown.
Methods detail (reference standard definition, device selection rationale, statistical analysis plan) not provided in registry record.
Agreement thresholds and clinically meaningful effect sizes not specified.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Observational, multi-modality comparison study with planned 300 participants.

Directness

strong

Direct measurement of body composition across clinical and commercial devices.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record.

Risk of bias

insufficient

Study is ongoing; risk of bias assessment premature without methods detail.

Sample adequacy

moderate

Estimated 300 participants planned; actual enrolment and completion unknown.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07776678). This is a study registration, not published results. Lead sponsor: Foundation for the National Institutes of Health. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 300 participants (ESTIMATED). Conditions: Obesity & Overweight. Primary outcome measures: Modality-reference agreement for total fat mass (kg) , 4 Weeks; Modality-reference agreement for fat-free mass (kg) , 4 Weeks; Modality-reference agreement for percent body fat (%) , 4 Weeks; Modality-reference agreement for visceral adipose tissue (VAT; kg or volume) , 4 Weeks. Brief summary: The purpose of this study is to evaluate body composition across a variety of medical, professional, and commercial devices, including: bioelectrical impedance analysis (BIA) devices, 3-dimensional optical imaging (3DO), manual anthropometry measurements, dual-energy X-ray absorptiometry (DXA), magnetic resonance imaging (MRI), and blood tests. The secondary study purpose is to compare body composition measurements from BIA devices, 3DO, and manual anthropometry measurements within a 1-week period for a subset of the study population. The study plans to enroll 300 healthy (having no life-threatening conditions or diseases; male and female) participants, 18 years of age or older.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Foundation for the National Institutes of HealthObesity & OverweightNCT07776678