Healthy Mom Zone Gestational Weight Gain Management Intervention 2.0
Public ClinicalTrials.gov record NCT05807594. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Efficacy of a Novel Digital Platform to Scale-Up a Personalized Prenatal Weight Gain Intervention Using Control Systems Methodology
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05807594
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 144 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 45 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 26, 2023
- Primary completion
- Jan 30, 2028
- Completion
- Jan 30, 2028
- Last update posted
- Jan 15, 2026
2023 – 2028
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pennsylvania State University | University Park | Pennsylvania | 16802 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05807594, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 15, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05807594 live on ClinicalTrials.gov.