Adaptive, Personalized Healthy Mom Zone Gestational Weight Gain Intervention with Novel Digital Platform and Automated Dosage Change Decisions: Study Design and Protocol (Preprint)
Authors: Downs Danielle Symons , Pauley Abigail M , Rivera Daniel E , Savage Jennifer S , Shao Danying , Chow Sy-Miin , Lagoa Constantino , Pauli Jaimey M , Khan Owais , Kunselman Allen 
Published: September 2024

BACKGROUND

Regulating gestational weight gain (GWG) is particularly challenging in pregnant women with overweight and obesity (PW-OW/OB) because of several challenges including a narrow range of weight gain that is recommended for optimal maternal and infant health outcomes. Given that many PW-OW/OB exceed the GWG recommendations and the lack of a “gold standard” intervention to regulate GWG, there is a critical and timely need for approaches that effectively and efficiently regulate GWG and have promise for future dissemination in clinical care. We have enhanced the Healthy Mom Zone intervention with a novel digital intervention delivery platform, automated dosage changes, and personalized behavioral intervention strategies to regulate GWG.

OBJECTIVE

The goal of the proposed research is to examine efficacy of the enhanced Healthy Mom Zone intervention with the new, automated control system and digital platform (HMZ 2.0) to regulate GWG and impact secondary maternal and infant outcomes while collecting implementation data to inform future scalability for delivery in prenatal care.

METHODS

HMZ 2.0 is a multi-dosage, individual-tailored, adaptive intervention with social cognitive theory and behavioral components that was designed with multiphase optimization and translational science frameworks and control systems methodology with the long-term goal to scale-up use by clinicians as adjunct treatment to prenatal care to regulate GWG. The intervention is delivered through a novel web-based digital platform that automates the linkage of participant data to a new model-based predictive control algorithm to predict GWG, computes optimized dosage changes across multiple maternal variables, and produces a host of personalized physical activity and energy intake strategies to deliver just-in-time dosage change recommendations directly to a participant to regulate GWG within guidelines.

RESULTS

Findings from the HMZ 2.0 pilot study showed successful recruitment from multiple methods, excellent participant compliance with the measurement protocol, transfer of data from devices and online surveys to the digital platform, and user acceptability of intervention sessions delivered through the platform, and utility of the predictive controller for informing dosage change decisions. Efficacy of the intervention will be examined in a randomized control optimization trial with 144 PW-OW/PB randomized to an intervention group (adaptive HMZ 2.0 intervention) or attention control group; this trial is currently ongoing.

CONCLUSIONS

Examining efficacy of the novel HMZ 2.0 intervention on GWG and related maternal and infant outcomes expands boundaries of current GWG interventions and has high clinical and public health impact in a high-risk population. There is excellent potential to further refine HMZ 2.0 in the future to scale-up use of the novel digital platform by clinicians as adjunct treatment in prenatal care to regulate GWG in all pregnant women.

CLINICALTRIAL

NIH Grant # 1R01DK134863, IRB # STUDY00019075, Clinical Trials Registration # NCT05807594