Actively Recruiting
Healthy Mom Zone Gestational Weight Gain Management Intervention 2.0
Led by Penn State University · Updated on 2026-01-16
144
Participants Needed
1
Research Sites
218 weeks
Total Duration
On this page
Sponsors
P
Penn State University
Lead Sponsor
A
Arizona State University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Healthy Mom Zone Gestational Weight Gain Management Intervention 2.0
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women
- Between 8 and less than 18 weeks gestation at screening
- Singleton pregnancy
- Not currently smoking more than 20 cigarettes per day
- Any number of previous pregnancies
- Any race or ethnicity
- Aged 18 to 45 years
- Body mass index (BMI) between 20.0 and 45.0
- Have not exceeded 25% or more of total gestational weight gain based on BMI and guidelines
- Have physician consent to participate
- Able to read, understand, and speak English
- Have access to a computer or phone
- Willing and able to complete study materials and sessions electronically or onsite
- Not currently using weight loss medications
- Not participating in another weight control study or program
- No planned bariatric surgery during current pregnancy
- No absolute contraindications to exercise in pregnancy and have provider consent for relative contraindications
You will not qualify if you...
- Not pregnant women
- Men (cannot become pregnant)
- Multiple pregnancies
- Less than 8 weeks or more than 18 weeks gestation at pre-intervention assessment
- Currently smoking more than 20 cigarettes per day
- Outside the age range of 18 to 45 years
- Outside the BMI range of 20.0 to 45.0
- Have exceeded 25% of total gestational weight gain based on BMI and guidelines
- Unable to read or understand English
- No access to computer or phone for study materials
- Currently using weight loss medications
- Participating in another weight control study or program
- Planned bariatric surgery during current pregnancy
- Absolute contraindications to aerobic exercise in pregnancy such as significant heart disease, restrictive lung disease (excluding asthma), incompetent cervix, severe anemia, multiple pregnancy at risk for premature labor, persistent bleeding, placenta previa after 26 weeks, premature labor, ruptured membranes, poorly controlled chronic hypertension, preeclampsia, or poorly controlled type 1 diabetes
- Relative contraindications to exercise without provider consent including unevaluated cardiac arrhythmia, chronic bronchitis, extreme morbid obesity (BMI over 40), extreme underweight (BMI under 12), history of very sedentary lifestyle, current eating disorder diagnosis, severe food allergies or dietary restrictions, intrauterine growth restriction, poorly controlled severe asthma, orthopedic limitations, poorly controlled seizure disorder, poorly controlled thyroid disease, uncontrolled sleep disorders such as insomnia or sleep-disordered breathing
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Pennsylvania State University
University Park, Pennsylvania, United States, 16802
Actively Recruiting
Research Team
A
Abigail Pauley, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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