← Back to Search

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

No Placebo-Only Group

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Gestational Weight Gain and Weight Change

Physical Activity (PA) and Sedentary Behavior

Secondary study objectives

Activity and Sleep Logs

Diet Quality

Implementation Markers: Clinician Stakeholder Facilitators and Barriers

+15 more

Other study objectives

Clinical/Safety Protocol: Blood Pressure/Urine

Clinical/Safety Protocol: Center for Epidemiological Studies Depression Scale

Clinical/Safety Protocol: Height

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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