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NCT05807594 · ClinicalTrials.gov registry record · NA
Healthy Mom Zone Gestational Weight Gain Management Intervention 2.0
A NA study of Pregnancy and Overweight and Obesity, sponsored by Penn State University.
- Recruiting
- Registry status
- NA
- Development phase
- 144
- Enrollment target
- 1
- Study location
NCT05807594 is a NA study of Pregnancy and Overweight and Obesity that is actively recruiting participants, run by Penn State University. The registered enrollment target is 144 participants, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05807594, a NA study of Pregnancy and Overweight and Obesity, is actively recruiting participants, sponsored by Penn State University.
- RECRUITING
- Registry status
- NA
- Development phase
- 144 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (83% lower). The listed sponsor is Penn State University, which has 219 total studies on file at ClinicalTrials.gov.
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.
NCT05807594 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
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.
What interventions are being tested in trial NCT05807594?
The interventions under investigation include: HMZ 2.0 Intervention (BEHAVIORAL), Attention Control Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT05807594?
This trial is sponsored by Penn State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
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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