Assessing Electronic Health Record-Derived Outcomes in a Pragmatic Weight Gain Prevention Trial: Effects, Variability, and Implications for Future Trials.

This is a secondary analysis of a trial whose primary weight gain prevention outcome was reported previously, so it does not directly establish the main effect of the intervention. The data came from routine clinical care rather than standardized study visits, and many cardiometabolic outcomes had few measurements, which reduced precision and power to detect effects. The COVID-19 pandemic reduced measurements during follow-up, limiting conclusions for the 12 to 24 month period. The trial was conducted in one network of Federally Qualified Health Centers in North Carolina, with most participants recruited from 2 sites, so measurement patterns may not generalize. Analyses did not adjust for medication use related to comorbidities, although the randomized design makes bias unlikely. The authors state that the 6-month blood pressure differences were not clinically meaningful and attenuated by 12 and 24 months.

The supplied text states that all other authors have no conflicts of interest to disclose. No funding source or sponsor role is reported.

Do not conclude that the digital weight gain prevention program improved cardiometabolic health overall. The paper reports no significant effects on other secondary or exploratory outcomes at any time point, and the 6-month systolic and diastolic blood pressure differences attenuated at later time points. Sparse electronic health record measurements also reduce precision.