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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: Recruiting NA study of Pregnancy and Overweight and Obesity, sponsored by Penn State University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Weight and GWG will be assessed daily at home using the FitBit Aria Air Smart Scale (weights will be uploaded to online program via Bluetooth). GWG will be standardized: target weight gain will be determined for each woman based on BMI status (OW = 15-25 lb., OB = 11-20 lb.). For the criterion measure to determine when to adapt the intervention, weight gain will be calculated to determine if a woman is gaining \< her goal (-), at the exact amount of her goal (0), or \> her goal (+). Pre-pregnanc
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 |
What NCT05807594 shows while recruiting
NCT05807594 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (83% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Pregnancy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05807594's enrollment target sits among peer trials
144 100th of 191 higher than 91 of 191 other Pregnancy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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