Trial Outcomes & Findings for Clinical Effectiveness of Body Fat Distribution Imaging in Real-World Practice: The BODY-REAL Study (NCT NCT04763772)
NCT ID: NCT04763772
Last Updated: 2025-03-25
Results Overview
Change in body mass index between groups
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
6 months
Results posted on
2025-03-25
Participant Flow
Participant milestones
| Measure |
Detailed Report + Patient Provided
A detailed read-out of body fat and muscle quantitation and distribution including visceral fat, abdominal subcutaneous fat, and thigh muscle volumes in liters, and thigh muscle fat infiltration (%) and liver fat (%), all presented on a visual scale compared with reference data from a normative, metabolic disease-free population (derived from the UK Biobank).
Report provided to the patient.
|
Basic Weight Information + Patient
A simple informational report consisting of weight, BMI, and a visual representation of their BMI. This report also categorizes their BMI into underweight, normal weight, overweight, or obese categories according to the World Health Organization categorization schema.
Basic Weight Information: Body weight and body mass index
Report provided to the patient.
|
Detailed Report + Doctor Provided
A detailed read-out of body fat and muscle quantitation and distribution including visceral fat, abdominal subcutaneous fat, and thigh muscle volumes in liters, and thigh muscle fat infiltration (%) and liver fat (%), all presented on a visual scale compared with reference data from a normative, metabolic disease-free population (derived from the UK Biobank).
Report provided to medical professional.
|
Basic Weight Information + Doctor Provided
A simple informational report consisting of weight, BMI, and a visual representation of their BMI. This report also categorizes their BMI into underweight, normal weight, overweight, or obese categories according to the World Health Organization categorization schema.
Basic Weight Information: Body weight and body mass index
Report provided to medical professional.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
8
|
7
|
|
Overall Study
COMPLETED
|
6
|
8
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Detailed Report + Patient Provided
n=6 Participants
A detailed read-out of body fat and muscle quantitation and distribution including visceral fat, abdominal subcutaneous fat, and thigh muscle volumes in liters, and thigh muscle fat infiltration (%) and liver fat (%), all presented on a visual scale compared with reference data from a normative, metabolic disease-free population (derived from the UK Biobank).
Report provided to the patient.
|
Basic Weight Information + Patient
n=8 Participants
A simple informational report consisting of weight, BMI, and a visual representation of their BMI. This report also categorizes their BMI into underweight, normal weight, overweight, or obese categories according to the World Health Organization categorization schema.
Basic Weight Information: Body weight and body mass index
Report provided to the patient.
|
Detailed Report + Doctor Provided
n=8 Participants
A detailed read-out of body fat and muscle quantitation and distribution including visceral fat, abdominal subcutaneous fat, and thigh muscle volumes in liters, and thigh muscle fat infiltration (%) and liver fat (%), all presented on a visual scale compared with reference data from a normative, metabolic disease-free population (derived from the UK Biobank).
Report provided to medical professional.
|
Basic Weight Information + Doctor Provided
n=7 Participants
A simple informational report consisting of weight, BMI, and a visual representation of their BMI. This report also categorizes their BMI into underweight, normal weight, overweight, or obese categories according to the World Health Organization categorization schema.
Basic Weight Information: Body weight and body mass index
Report provided to medical professional.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 8.0 • n=6 Participants
|
60.5 years
STANDARD_DEVIATION 13.9 • n=8 Participants
|
66.0 years
STANDARD_DEVIATION 9.9 • n=8 Participants
|
64.3 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
63.0 years
STANDARD_DEVIATION 10.3 • n=29 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=6 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=6 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
6 Participants
n=7 Participants
|
20 Participants
n=29 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
6 Participants
n=6 Participants
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
7 Participants
n=7 Participants
|
29 Participants
n=29 Participants
|
|
Body Mass Index
|
32.2 kg/m2
STANDARD_DEVIATION 3.1 • n=6 Participants
|
35.1 kg/m2
STANDARD_DEVIATION 6.3 • n=8 Participants
|
31.5 kg/m2
STANDARD_DEVIATION 4.9 • n=8 Participants
|
35.5 kg/m2
STANDARD_DEVIATION 8.3 • n=7 Participants
|
33.6 kg/m2
STANDARD_DEVIATION 6.0 • n=29 Participants
|
PRIMARY outcome
Timeframe: 6 monthsChange in body mass index between groups
Outcome measures
| Measure |
Detailed Report + Patient Provided
n=6 Participants
A detailed read-out of body fat and muscle quantitation and distribution including visceral fat, abdominal subcutaneous fat, and thigh muscle volumes in liters, and thigh muscle fat infiltration (%) and liver fat (%), all presented on a visual scale compared with reference data from a normative, metabolic disease-free population (derived from the UK Biobank).
Report provided to the patient.
|
Basic Weight Information + Patient
n=8 Participants
A simple informational report consisting of weight, BMI, and a visual representation of their BMI. This report also categorizes their BMI into underweight, normal weight, overweight, or obese categories according to the World Health Organization categorization schema.
Basic Weight Information: Body weight and body mass index
Report provided to the patient.
|
Detailed Report + Doctor Provided
n=8 Participants
A detailed read-out of body fat and muscle quantitation and distribution including visceral fat, abdominal subcutaneous fat, and thigh muscle volumes in liters, and thigh muscle fat infiltration (%) and liver fat (%), all presented on a visual scale compared with reference data from a normative, metabolic disease-free population (derived from the UK Biobank).
Report provided to medical professional.
|
Basic Weight Information + Doctor Provided
n=7 Participants
A simple informational report consisting of weight, BMI, and a visual representation of their BMI. This report also categorizes their BMI into underweight, normal weight, overweight, or obese categories according to the World Health Organization categorization schema.
Basic Weight Information: Body weight and body mass index
Report provided to medical professional.
|
|---|---|---|---|---|
|
Change in BMI
|
0.43 kg/m2
Interval -6.3 to 7.2
|
0 kg/m2
Interval 0.0 to 0.0
|
4.4 kg/m2
Interval -2.0 to 11.0
|
0 kg/m2
Interval 0.0 to 0.0
|
Adverse Events
Detailed Report + Patient Provided
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Basic Weight Information + Patient
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Detailed Report + Doctor Provided
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Basic Weight Information + Doctor Provided
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place