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HMZ 2.0 Intervention for Pregnancy Weight Management (HMZ Two Trial)

N/A

Recruiting

Research Sponsored by Penn State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at study completion and once all participants have completed the study, which could be roughly 2 years after start of study

Awards & highlights

HMZ Two Trial Summary

This trial tests a new intervention & digital platform to see if it helps pregnant women manage their weight & improve outcomes for them & their babies.

Who is the study for?

This trial is for pregnant women aged 18-45, with a BMI of 25.0 to 45.0, living in specific areas of Pennsylvania. They must be at 8-15 weeks gestation and have their doctor's consent to participate. Women over a BMI of 40 will need extra checks from their healthcare provider.Check my eligibility

What is being tested?

The study tests the HMZ 2.0 intervention against an attention control group to manage weight during pregnancy and improve mother-infant outcomes using daily self-monitoring and weekly sessions with dieticians versus pain management education.See study design

What are the potential side effects?

Since this is a behavioral intervention focusing on education and lifestyle changes rather than medication or medical procedures, significant side effects are not anticipated beyond the normal risks associated with pregnancy.

HMZ Two Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at study completion and once all participants have completed the study, which could be roughly 2 years after start of study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at study completion and once all participants have completed the study, which could be roughly 2 years after start of study

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at study completion and once all participants have completed the study, which could be roughly 2 years after start of study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Energy Intake (EI) Estimation (Back-Calculation of Energy Intake)

Gestational Weight Gain and Weight Change

Physical Activity (PA) and Sedentary Behavior

Secondary outcome measures

Activity and Sleep Logs

Diet Quality

Implementation Markers: Clinician Stakeholder Facilitators and Barriers

+15 more

Other outcome measures

Clinical/Safety Protocol: Blood Pressure/Urine

Clinical/Safety Protocol: Center for Epidemiological Studies Depression Scale

Clinical/Safety Protocol: Height

+1 more

HMZ Two Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: HMZ 2.0 Intervention GroupExperimental Treatment1 Intervention

HMZ 2.0 will be delivered by a registered dietitian in weekly didactic, one-on-one discussions in remote synchronous format (e.g., Zoom). If a subject has internet connectivity issues, she will be able to participate in the remote sessions from an onsite location (e.g., laboratory space on the Penn State University Park campus, clinical space at Hershey campus or Geisinger). All intervention women will receive the baseline intervention delivered as a maximum of 24 weekly modules (depending on gestational age at enrollment) which includes: Education and Counseling (GWG/PA/EI/sedentary behaviors/sleep behaviors/stress management, etc.), Goal-Setting and Action Plans (guided and self-selected PA/EI goals including recipe and workout booklet use), Self-Monitoring (wearing/using mHealth tools to monitor GWG/PA/EI/sleep), and Featured Evidence and Fetal Growth Facts (evidence-based studies and baby growth fun facts shared with women about how mom's health impacts her baby).

Group II: Attention Control GroupActive Control1 Intervention

All women will receive prenatal care offered by recruitment sites with routine provider visits, prenatal counseling, brief discussions on healthy prenatal behaviors, and clinical oversight of health (e.g., monitor glucose levels if diagnosed with gestational diabetes during the study period). Women randomized to the attention control group will complete the same measurement procedures as the intervention group. To match the HMZ intervention group, women will receive weekly, remote-delivered education content (60 min/session) on preparing for labor/delivery and benefits of behavioral pain management strategies (e.g., mindfulness-based relaxation, imagery, music, massage, deep-breathing) to regulate pain after childbirth with non-pharmacological approaches. Content is drawn from evidence-based guidelines and materials designed by Dr. Downs and her team for a Patient-Provider Toolbox to reduce opioid-related pain management use after childbirth.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Penn State UniversityLead Sponsor

355 Previous Clinical Trials

125,613 Total Patients Enrolled

Arizona State UniversityOTHER

283 Previous Clinical Trials

109,370 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are partaking in this research endeavor?

"Affirmative. The clinicaltrials.gov webpage reveals that the trial, which was launched on November 27th 2023 and most recently modified on November 21st 2023 is actively recruiting participants. Recruitment currently requires 144 patients to be sourced from 1 medical institution."

Answered by AI

Does the protocol of this study encompass individuals below 45 years old?

"This medical trial has set the lower age limit for participants to 18 and the upper limit at 45. For those under 18, there are 124 clinical trials available. Likewise, 376 studies have been designed with elderly patients in mind."

Answered by AI

What are the principal aims of this investigation?

"The general goal of this trial is to assess the effects of intervention on Physical Activity (PA) and Sedentary Behavior. Secondary objectives include a shift in overall sleep quality, which will be evaluated using the Pittsburgh Sleep Quality Index. Additionally, Theory of Planned Behavior Constructs such as healthy eating/limit unhealthy eating attitude, subjective norm, perceived behavioral control and intention are also being measured daily at pre-post intervention and throughout the duration of the study (~6 months)."

Answered by AI

Is recruitment still occurring for this experiment?

"Information from clinicaltrials.gov verifies that this trial is still sourcing participants; the study's listing was initially created on November 27th 2023 and edited lastly on Nov 21st 2023."

Answered by AI

May I partake in this medical experiment and become a participant?

"This medical trial is seeking 144 participants aged 18 to 45 who are considered obese. To qualify, prospective patients must additionally satisfy the following conditions: they should be between 8-15 weeks of pregnancy and have a singleton gestation, any race or ethnicity can apply, BMI ranging from 25 to 40 (if over 40 then consulting with their healthcare provider may be necessary), need physician consent for participation, able to read English fluently, reside in Central Pennsylvania during the study period at either Penn State Hershey Medical Center or Geisinger Danville."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Healthy Mom Zone Gestational Weight Gain Management Intervention 2.0

Danielle Downs 2023. "Healthy Mom Zone Gestational Weight Gain Management Intervention 2.0". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05807594.

All > Weight Gain