An Optimized Behavioral Intervention for Managing Gestational Weight Gain Using Semi-Physical Modeling and Hybrid Model Predictive Control.
Owais Khan, Francesco Campregher, Daniel E Rivera...
https://pubmed.ncbi.nlm.nih.gov/41306560Actively Recruiting
Phase Not Applicable
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
ID05807594
Efficacy of a Novel Digital Platform to Scale-Up a Personalized Prenatal Weight Gain Intervention Using Control Systems Methodology
Led by Penn State University · Updated on 2026-01-16
144
Participants Needed
1
Research Sites
N/A
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
Researchers are studying pregnant women with overweight or obesity to see if an enhanced digital platform called HMZ 2.0 can help manage gestational weight gain (GWG) and improve maternal and infant outcomes. This study also aims to understand how the intervention impacts sleep and eating habits, and whether the digital platform can be effectively used in different healthcare settings. A total of 144 pregnant women will participate, starting between about 8 and 36 weeks of pregnancy. Participants will be randomly assigned to one of two groups: the HMZ 2.0 intervention or an attention control group. Those in the HMZ 2.0 group will have weekly remote sessions with a registered dietitian focusing on education, goal-setting, self-monitoring, and behavior strategies related to weight gain, physical activity, sleep, eating, and preparation for labor and postpartum. The control group will receive weekly education on labor preparation and non-medication pain management techniques after childbirth. Both groups will continue their usual prenatal care during the study. Throughout the study, participants will weigh themselves daily and wear activity monitors to track physical activity, sleep, and sedentary behavior. They will complete regular online surveys about their thoughts, behaviors, and mental health. Data collection will happen daily, weekly, and monthly during the roughly six-month intervention period. Researchers will also review labor and delivery records to measure outcomes. The study includes detailed monitoring of gestational weight gain, energy intake, physical activity, and sleep quality to evaluate the intervention's effects and gather information for future healthcare use.
CONDITIONS
Brief Title
Healthy Mom Zone Gestational Weight Gain Management Intervention 2.0
Who Can Participate
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
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
- Ages 18 to 45 years
- Body mass index (BMI) between 20.0 and 45.0 (consultation required if BMI over 40)
- Have not exceeded 25% or more of total gestational weight gain from pre-pregnancy to enrollment
- Physician consent to participate
- Able to read, understand, and speak English
- Access to a computer or phone
- Willing and able to complete study materials and sessions electronically or onsite if needed
- Not currently using weight loss medications
- Not participating in another weight control study or program
- No planned bariatric surgery during this pregnancy
- No absolute or relative contraindications to exercise in pregnancy without provider consent
You will not qualify if you...
- Not pregnant women
- Men (unable to become pregnant)
- Multiple pregnancy (twins, triplets, etc.)
- Less than 8 weeks or more than 18 weeks gestation at pre-intervention assessment
- Currently smoking more than 20 cigarettes per day
- Outside age range of 18 to 45 years
- Outside BMI range of 20.0 to 45.0
- Have exceeded 25% of total gestational weight gain from pre-pregnancy to enrollment
- 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 intervention
- Planned bariatric surgery during this pregnancy
- Absolute contraindications to exercise including serious heart disease, restrictive lung diseases (excluding asthma), incompetent cervix, severe anemia, multiple gestation at risk for premature labor, persistent bleeding in second or third trimester, placenta previa after 26 weeks, premature labor, ruptured membranes, poorly controlled hypertension, preeclampsia, poorly controlled type 1 diabetes
- Relative contraindications to exercise without provider permission including unevaluated cardiac arrhythmia, chronic bronchitis, extreme obesity (BMI over 40), extreme underweight (BMI under 12), sedentary lifestyle, eating disorders, severe food allergies or dietary restrictions, intrauterine growth restriction, poorly controlled respiratory disorders, orthopedic limitations, poorly controlled seizure or thyroid disorders, uncontrolled sleep disorders (insomnia, sleep apnea)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or via Zoom) lasting approximately 90 minutes for consent and baseline assessments.
Pre-intervention Free-living Baseline Assessment
Duration - 7 to 9 days
Participants complete a 7 to 9-day monitoring period at home to establish baseline physical activity, energy intake, sleep, and eating behaviors using mHealth tools and daily surveys.
Daily remote self-reporting and device use during this period.
Intervention
Duration - Up to 24 weeks
Participants receive either the HMZ 2.0 digital platform behavioral intervention with weekly remote sessions led by a registered dietitian or attention control education sessions on prenatal behaviors, both lasting up to 24 weeks depending on gestational age at enrollment. Continuous daily monitoring of gestational weight gain, physical activity, energy intake, sleep, and related behaviors occurs throughout this period.
Weekly remote sessions (60 minutes each) plus daily use of mHealth tools and surveys.
Trial Site Locations
Total: 1 location
1
Pennsylvania State University
University Park, Pennsylvania, United States, 16802
Actively Recruiting
Loading map...
Research Team
A
Abigail Pauley, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Performance evaluation of a machine learning-based methodology using dynamical features to detect nonwear intervals in actigraphy data in a free-living setting.
Jyotirmoy Nirupam Das, Linying Ji, Yuqi Shen...
https://pubmed.ncbi.nlm.nih.gov/39788836Measurement Model Misspecification in Dynamic Structural Equation Models: Power, Reliability, and Other Considerations.
Hyungeun Oh, Michael D Hunter, Sy-Miin Chow
https://pubmed.ncbi.nlm.nih.gov/40556684Healthy Mom Zone Adaptive Intervention With a Novel Control System and Digital Platform to Manage Gestational Weight Gain in Pregnant Women With Overweight or Obesity: Study Design and Protocol for a Randomized Controlled Trial.
Danielle Symons Downs, Abigail M Pauley, Daniel E Rivera...
https://pubmed.ncbi.nlm.nih.gov/40080809