Trial results for a study investigating obesity interventions were posted on ClinicalTrials.gov on 2025-06-12, with 60 participants enrolled.
Background
Obesity is a complex, chronic disease characterized by excessive body fat, which significantly increases the risk of various health complications, including type 2 diabetes, cardiovascular disease, and certain cancers. Effective management often involves a combination of lifestyle modifications, behavioral therapy, and sometimes pharmacotherapy or surgical interventions. Research into comparative effectiveness, particularly using data embedded within electronic health record (EHR) systems, is crucial for evaluating the real-world impact of different weight loss strategies and common clinical practices. This study aimed to develop and demonstrate new informatics systems and statistical methods to support randomization processes within EHR systems for comparative effectiveness research in obesity.
Trial design
This completed study, designated as Phase NA, enrolled 60 participants with the condition of Obesity. The trial aimed to evaluate different weight loss interventions as part of a broader project to develop EHR-embedded comparative effectiveness research methods. While specific primary outcomes were not listed, the study assessed compliance rates and changes in Body Mass Index (BMI). Participants were assigned to intervention groups involving either a dietician or a health coach, or a combination thereof, as indicated by the outcome measurement groups.
Key results
The trial reported several key measurements related to intervention compliance and BMI changes:
- Compliance Rate:
- For the "Dietician / Health Coach" group, the compliance rate was 87 percentage of participants.
- For the "Health Coach / Dietician" group, the compliance rate was 76 percentage of participants.
- Percentage of Eligible Patients Participating:
- Among "All Eligible Patients", the participation rate was 13.1 percentage of eligible patients.
- Change in Body Mass Index (BMI) at 30 Days:
- In the "Dietician / Health Coach" group, the mean change in BMI was -0.07 kg/m^2 (Standard Error 0.25).
- In the "Health Coach / Dietician" group, the mean change in BMI was -0.16 kg/m^2 (Standard Error 0.20).
What this means
The posted results offer initial data on the feasibility and preliminary outcomes of EHR-embedded comparative effectiveness research for obesity. The study observed modest reductions in BMI at 30 days across both intervention groups, with the "Health Coach / Dietician" group showing a slightly larger mean decrease. Compliance rates for the interventions were relatively high, ranging from 76% to 87%. However, the low overall participation rate of 13.1% among eligible patients highlights potential challenges in recruiting and engaging participants in such EHR-based studies. These findings contribute to understanding the practical aspects and initial impact of integrating weight loss interventions within routine clinical practice via EHR systems.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04514679, titled "EHR Embedded Comparative Effectiveness Studies--WWC", were posted on 2025-06-12 on clinicaltrials.gov.