The BODY-REAL Study was a 2 × 2 factorial design RCT that assessed whether providing patients with (1) visual body fat MRI reports compared with weight/body mass index (BMI) alone and (2) direct-to-patient reports versus through providers would improve cardiometabolic risk among individuals at elevated cardiometabolic risk (BMI ≥ 25 kg/m2, Hb A1C ≥ 5.7% and additional risk factors). We found that MRI report recipients had lower fasting glucose and higher physical activity scores and that provider-mediated reporting was associated with greater medication adherence and perception of personal disease control but lower perception of disease risk. The study was underpowered to detect significant change in other cardiometabolic markers but demonstrated potential for direct-to-patient visualization of body at distribution to improve cardiometabolic risk markers and preventive behaviors, warranting additional sufficiently powered studies.
ABSTRACT
Objective
Advanced imaging can inform risk assessment and preventive/therapeutic decision-making to enhance care. It is not known how quantification of body fat distribution using advanced imaging and communication of the result through a graphic report may impact cardiometabolic risk factors and attitudes/behaviors among persons living with overweight or obesity. The BODY-REAL study assessed whether providing patients with (1) visual body fat MRI reports compared with the weight/body mass index (BMI) alone and (2) direct-to-patient reports versus through providers would improve cardiometabolic risk among individuals at elevated cardiometabolic risk.
Methods
Participants were randomized in a 2 × 2 factorial design to receive a BMI or MRI body fat distribution report, provided direct-to-patient report or a report through their healthcare provider. Clinical and psychosocial outcomes were measured at 2 weeks, 3, and 6 months and compared using analysis of covariance and linear models with both fixed and random (time-updated) effects.
Results
29 participants (31% female, mean BMI 33.6 kg/m2) were randomized. After 6 months of follow-up, MRI report recipients had lower fasting glucose and higher physical activity scores (p < 0.01). Provider-mediated reporting demonstrated greater medication adherence (p = 0.01) and greater perception of personal control of diabetes (p = 0.02) but lower perception of diabetes-related risk (p = 0.003). There were no significant differences in BMI, blood pressure, cholesterol, glycosylated hemoglobin, or other risk perception across study arms.
Conclusions
This pilot feasibility study demonstrated potential for direct-to-patient visualization of body fat distribution to improve risk markers and preventive behaviors. Further investigation in a sufficiently powered study is warranted.
Trial Registration
ClinicalTrials.gov NCT04763772