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BACKGROUND

Regulating gestational weight gain (GWG) in pregnant women with overweight or obesity is difficult, particularly because of the narrow range of recommended GWG for optimal health outcomes. Given that many pregnant women show excessive GWG and considering the lack of a "gold standard" intervention to manage GWG, there is a timely need for effective and efficient approaches to regulate GWG. We have enhanced the Healthy Mom Zone (HMZ) 2.0 intervention with a novel digital platform, automated dosage changes, and personalized strategies to regulate GWG, and our pilot study demonstrated successful recruitment, compliance, and utility of our new control system and digital platform.

OBJECTIVE

The goal of this paper is to describe the study protocol for a randomized controlled optimization trial to examine the efficacy of the enhanced HMZ 2.0 intervention with the new automated control system and digital platform to regulate GWG and influence secondary maternal and infant outcomes while collecting implementation data to inform future scalability.

METHODS

This is an efficacy study using a randomized controlled trial design. HMZ 2.0 is a multidosage, theoretically based, and individually tailored adaptive intervention that is delivered through a novel digital platform with an automated link of participant data to a new model-based predictive control algorithm to predict GWG. Our new control system computes individual dosage changes and produces personalized physical activity (PA) and energy intake (EI) strategies to deliver just-in-time dosage change recommendations to regulate GWG. Participants are 144 pregnant women with overweight or obesity randomized to an intervention (n=72) or attention control (n=72) group, stratified by prepregnancy BMI (<29.9 vs ≥30 kg/m), and they will participate from approximately 8 to 36 weeks of gestation. The sample size is based on GWG (primary outcome) and informed by our feasibility trial showing a 21% reduction in GWG in the intervention group compared to the control group, with 3% dropout. Secondary outcomes include PA, EI, sedentary and sleep behaviors, social cognitive determinants, adverse pregnancy and delivery outcomes, infant birth weight, and implementation outcomes. Analyses will include descriptive statistics, time series and fixed effects meta-analytic approaches, and mixed effects models.

RESULTS

Recruitment started in April 2024, and enrollment will continue through May 2027. The primary (GWG) and secondary (eg, maternal and infant health) outcome results will be analyzed, posted on ClinicalTrials.gov, and published after January 2028.

CONCLUSIONS

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

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/66637.

背景

对于超重或肥胖的孕妇，控制孕期体重增加（GWG）具有挑战性，特别是鉴于为实现最佳健康结果而推荐的GWG范围较窄。鉴于许多孕妇孕期体重增加过多，且缺乏管理GWG的“金标准”干预措施，因此迫切需要有效且高效的方法来控制GWG。我们通过一个新型数字平台、自动剂量调整和个性化策略对健康妈妈区（HMZ）2.0干预措施进行了强化，以控制GWG，我们的初步研究证明了新控制系统和数字平台在成功招募、依从性和实用性方面的表现。

目的

本文的目的是描述一项随机对照优化试验的研究方案，以检验强化后的HMZ 2.0干预措施与新的自动控制系统和数字平台在控制GWG以及影响母婴次要结局方面的疗效，同时收集实施数据以为未来的可扩展性提供参考。

方法

这是一项采用随机对照试验设计的疗效研究。HMZ 2.0是一种多剂量、基于理论且个性化定制的适应性干预措施，通过一个新型数字平台实施，该平台将参与者数据自动链接到一个新的基于模型的预测控制算法以预测GWG。我们的新控制系统计算个体剂量变化，并生成个性化的身体活动（PA）和能量摄入（EI）策略，以提供即时剂量变化建议来控制GWG。参与者为144名超重或肥胖的孕妇，随机分为干预组（n = 72）或注意力对照组（n = 72），按孕前BMI（<29.9 vs≥30 kg/m²）分层，她们将在妊娠约8至36周期间参与研究。样本量基于GWG（主要结局）确定，并参考我们的可行性试验结果，该试验显示干预组的GWG比对照组减少了21%，脱落率为3%。次要结局包括PA、EI、久坐和睡眠行为、社会认知决定因素、不良妊娠和分娩结局、婴儿出生体重以及实施结局。分析将包括描述性统计、时间序列和固定效应荟萃分析方法以及混合效应模型。