University Park, PANCT05807594Now EnrollingIRB Ready

Gestational Weight Gain Clinical Trial in University Park, PA

Access cutting-edge gestational weight gain treatment through this clinical trial at a research site in University Park. Study-provided care at no cost to qualified participants.

Sponsored by Penn State University

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Expert Care in University Park

Access gestational weight gain specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related gestational weight gain treatment provided free

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Check if you qualify for this gestational weight gain clinical trial in University Park, PA

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Why Participate?

  • No-Cost Study Care

  • Local to University Park

    Convenient for PA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit University Park site if eligible
  4. 4Begin participation

About This Gestational Weight Gain Study in University Park

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.

Sponsor: Penn State University

Who Can Participate

Inclusion Criteria

Pregnant women
≥ 8 and \< 18 weeks gestation at time of screening. This range of gestational age is chosen to: a) reduce chances of false pregnancy or miscarriage under 8 weeks gestation and b) recruit women in the 1st trimester for greatest impact of the intervention on gestational weight gain. In the feasibility and initial impact study, the investigators had less than 10% (n=3) miscarriages prior to randomization using these criteria
Singleton gestation
Not currently heavily smoking (\>20 cigarettes/day)
Any parity (i.e., first-time pregnancy, second pregnancy, etc.)
Any race/ethnicity
Ages 18-45 years
Body mass index (BMI) range 20.0 to 45.0. If BMI is over 40, consultation with woman's health care provider will be made to determine eligibility and ensure she does not have any contraindications to physical activity or other concerns with intervention participation.
Haven't exceeded 25% or more of their total GWG (based on BMI and IOM guidelines) from pre-pregnancy to date of enrollment.
Participant has physician consent to confirm subject participation
Able to read, understand, and speak English
Access to a computer/phone
Willingness and ability to complete study materials and intervention sessions electronically (e.g., email, Facetime, Zoom), at home (e.g., Zoom sessions delivered synchronous and asynchronous) or if requested by the participant, on-site at Penn State University Park or Hershey campuses.
No current use of weight loss medications
No current participation in another interventional study or program that influences weight control
No planned bariatric surgery during this current pregnancy
No absolute contraindications to exercise in pregnancy and relative contraindications with provider consent (see below)

Exclusion Criteria

Not pregnant women
Men (unable to become pregnant)
Multiple gestation
\< 8 weeks gestation or \> 18 weeks gestation at time of pre-intervention assessment
Currently smoking \> 20 cigarettes/day
Outside of the age range of 18-45 years
Outside of the BMI range of 20.0-45.0
Exceeded 25% of their total GWG (based on BMI and IOM guidelines) from pre-pregnancy to date of enrollment
Not able to read and/or understand English
Unable to access materials by computer or phone (even with data plan assistance if necessary)
Current use of weight loss medications
Current participation in another interventional study or program that influences weight control
Planned bariatric surgery during this current pregnancy
Contraindications to aerobic exercise in pregnancy: Absolute contraindications to exercise:
Hemodynamically significant heart disease
Restrictive lung disease (pulmonary fibrosis, sarcoidosis, pleural effusion, neuromuscular disease). This DOES NOT include ASTHMA
Incompetent cervix/cerclage
Severe anemia
Multiple gestation at risk for premature labor
Persistent 2nd or 3rd trimester bleeding
Placenta previa after 26 weeks gestation
Premature labor during the current pregnancy
Ruptured membranes
Poorly controlled chronic hypertension
Preeclampsia diagnosis during current pregnancy
Poorly controlled Type 1 diabetes Relative contraindications to exercise (if permission is not given by provider):
Unevaluated maternal cardiac arrhythmia
Chronic bronchitis
Extreme morbid obesity (BMI \> 40.0; needs provider consent to participate)
Extreme underweight (BMI \< 12.0)
History of extremely sedentary lifestyle
Current eating disorder(s) diagnosis
Severe food allergies and/or dietary restrictions that may preclude study participation.
Intrauterine growth restriction in current pregnancy
Poorly controlled respiratory disorder (severe asthma) that precludes study participation
Orthopedic limitations
Poorly controlled seizure disorder
Poorly controlled thyroid disease
Uncontrolled sleep disorder (insomnia, sleep-disordered breathing)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in University Park?

Yes, this clinical trial (NCT05807594) has an active research site in University Park, PA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Gestational Weight Gain Treatment Options in University Park, PA

If you're searching for gestational weight gain treatment options in University Park, PA, this clinical trial (NCT05807594) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our University Park research site is actively enrolling participants for this clinical trial. You'll receive care from experienced gestational weight gain specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all gestational weight gain clinical trials near you to find additional studies recruiting in your area.

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