An Optimized Behavioral Intervention for Managing Gestational Weight Gain Using Semi-Physical Modeling and Hybrid Model Predictive Control.
Owais Khan, Francesco Campregher, Daniel E Rivera...
https://pubmed.ncbi.nlm.nih.gov/41306560/Actively Recruiting
Led by Penn State University · Updated on 2026-01-16
144
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are studying pregnant women with overweight or obesity to see if an enhanced digital platform called HMZ 2.0 can help manage gestational weight gain GWG and improve maternal and infant outcomes. This study also aims to understand how the intervention impacts sleep and eating habits, and whether the digital platform can be effectively used in different healthcare settings. A total of 144 pregnant women will participate, starting between about 8 and 36 weeks of pregnancy. Participants will be randomly assigned to one of two groups the HMZ 2.0 intervention or an attention control group. Those in the HMZ 2.0 group will have weekly remote sessions with a registered dietitian focusing on education, goal-setting, self-monitoring, and behavior strategies related to weight gain, physical activity, sleep, eating, and preparation for labor and postpartum. The control group will receive weekly education on labor preparation and non-medication pain management techniques after childbirth. Both groups will continue their usual prenatal care during the study. Throughout the study, participants will weigh themselves daily and wear activity monitors to track physical activity, sleep, and sedentary behavior. They will complete regular online surveys about their thoughts, behaviors, and mental health. Data collection will happen daily, weekly, and monthly during the roughly six-month intervention period. Researchers will also review labor and delivery records to measure outcomes. The study includes detailed monitoring of gestational weight gain, energy intake, physical activity, and sleep quality to evaluate the interventions effects and gather information for future healthcare use.
CONDITIONS
Healthy Mom Zone Gestational Weight Gain Management Intervention 2.0
A
Abigail Pauley, PhD
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Penn State University
Lead Sponsor
Arizona State University
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Digital Adaptive Weight Management Platform | Standard Prenatal Care & Counseling |
|---|---|---|
| What it is | A digital platform offering adaptive behavioral support for managing gestational weight gain during pregnancy. Features include real-time weight tracking, personalized dietary and physical activity guidance, and tailored intervention adjustment based on predictive control models and dietitian review. | Participants receive standard prenatal care found in routine practice, including regular provider visits, healthy pregnancy counseling (such as smoking cessation), and clinical health oversight. Measurement procedures mirror those in the intervention group. |
| Role in trial | Randomized intervention arm assigned to receive adaptive weight management support via digital platform, aiming to regulate gestational weight gain within recommended guidelines. | Randomized comparator arm assigned to standard prenatal care, acting as attention control to evaluate the digital intervention's impact against routine practice. |
| Primary use | Designed to support pregnant women in managing gestational weight gain by providing timely, personalized behavioral recommendations and monitoring adherence to healthy eating and physical activity goals. | Provides routine health and pregnancy counseling to support healthy behaviors according to standard prenatal care guidelines without specialized digital adaptation. |
| How it is given or performed | Interaction with the platform occurs online and at home, via digital delivery (email, Facetime, Zoom) or in-person as requested. The system frequently evaluates gestational weight gain and adapts intervention dosage; a dietitian reviews suggested strategies and tailors physical activity and dietary recommendations. | Standard prenatal care is provided during routine clinic visits, including counseling and health oversight. Measurement procedures are matched to the intervention arm and are delivered without digital adaptation. |
| Evidence status | The Healthy Mom Zone 2.0 adaptive intervention is supported by feasibility studies and protocol publications, but full effectiveness results are pending. Prior work suggests potential benefit in regulating weight gain, but robust clinical outcome data are not yet available. | Standard prenatal care represents established practice but does not specifically target adaptive digital weight management. Guidelines support routine counseling and health monitoring as effective components for pregnancy care. |
| Important limitations | Effectiveness and safety are not yet established in large randomized populations. The digital intervention may require ongoing access to technology and responsive engagement; some participants may not benefit from the adaptive approach if they lack device access or prefer traditional methods. | Standard prenatal care may not provide tailored behavioral guidance for weight gain management; support is limited to guidance and counseling, without adaptive digital features. Outcomes depend on clinic visit frequency and practitioner engagement. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or via Zoom) lasting approximately 90 minutes for consent and baseline assessments.
Duration - 7 to 9 days
Participants complete a 7 to 9-day monitoring period at home to establish baseline physical activity, energy intake, sleep, and eating behaviors using mHealth tools and daily surveys.
Daily remote self-reporting and device use during this period.
Duration - Up to 24 weeks
Participants receive either the HMZ 2.0 digital platform behavioral intervention with weekly remote sessions led by a registered dietitian or attention control education sessions on prenatal behaviors, both lasting up to 24 weeks depending on gestational age at enrollment. Continuous daily monitoring of gestational weight gain, physical activity, energy intake, sleep, and related behaviors occurs throughout this period.
Weekly remote sessions (60 minutes each) plus daily use of mHealth tools and surveys.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/39788836/Penn State University
Lead Sponsor
Arizona State University
Collaborating Sponsor