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Healthy Mom Zone Gestational Weight Gain Management Intervention 2.0
NCT05807594 · View on ClinicalTrials.gov ↗
Study Summary
The goal of this clinical trial is to see if the enhanced HMZ 2.0 intervention with new control system/digital platform to regulate gestational weight gain (GWG) and impact maternal-infant outcomes while collecting implementation data works and can be given to other pregnant women in various settings. The question this study aims to answer are: 1. Does the new intervention manage GWG? 2. Does the new intervention have any influence on sleep and eating behaviors and infant outcomes. 3. Does the new platform and other data collected help inform how well the research and information can be used in health care settings? 144 pregnant women with overweight/obesity will be randomized to either the HMZ 2.0 intervention or attention control groups from \~8-36 weeks gestation. All participants will be asked to: 1. Weight themselves and wear an activity monitor each day over the study. 2. Complete online surveys at either a weekly or monthly level about their thoughts, attitudes, and behaviors on GWG, physical activity, eating behaviors, sleep, their anxiety, depression, and stress. 3. Attend weekly sessions with a registered dietician. The weekly sessions will differ based on intervention group. The HMZ 2.0 intervention group will receive education, create and follow goal-setting and action plans, self-monitor their behaviors, and receive feature evidence and fetal growth facts. Education, goals, and self-monitoring will focus on GWG, physical activity, eating behaviors, sleep, self-regulating behaviors and emotions, and preparing for labor/delivery and postpartum. The attention control group will receive weekly sessions on preparing for labor/delivery and benefits of behavioral pain management strategies (e.g., mindfulness-based relaxation, imagery, music, massage, deep-breathing) to help with pain after childbirth without medicine.
Conditions Studied
Interventions
- BEHAVIORAL HMZ 2.0 Intervention
- BEHAVIORAL Attention Control Intervention
Study Locations (1)
Pennsylvania
- Pennsylvania State University — University Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2023-11-27 |
| Est. Completion | 2028-01-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05807594
The ClinicalTrials.gov registry entry for NCT05807594 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Penn State University, which has 233 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Pregnancy appearing as the primary indexed condition, and to 2 interventions — of which HMZ 2.0 Intervention is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05807594 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05807594 about?
NCT05807594 is a clinical study titled "Healthy Mom Zone Gestational Weight Gain Management Intervention 2.0". The goal of this clinical trial is to see if the enhanced HMZ 2.0 intervention with new control system/digital platform to regulate gestational weight gain (GWG) and impact maternal-infant outcomes while collecting implementation data works and can be given to other pregnant women in various setting...
What is the current status of trial NCT05807594?
This trial is currently recruiting. It is a NA study. The enrollment target is 144 participants. The study started on 2023-11-27. Estimated completion is 2028-01-31.
What conditions does trial NCT05807594 study?
This clinical trial studies the following conditions: Pregnancy, Overweight and Obesity, Gestational Weight Gain, Energy Balance. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05807594?
The interventions under investigation include: HMZ 2.0 Intervention (BEHAVIORAL), Attention Control Intervention (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05807594?
This trial is sponsored by Penn State University, which has 233 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05807594 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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