Managing weight gain during pregnancy with a new digital intervention
Efficacy of a Novel Digital Platform to Scale-Up a Personalized Prenatal Weight Gain Intervention Using Control Systems Methodology
This study is testing a new digital program to help pregnant women who are overweight or obese manage their weight gain during pregnancy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Penn State University Academic / other |
| Locations | 1 site (University Park, Pennsylvania) |
| Trial ID | NCT05807594 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of the Healthy Mom Zone 2.0 intervention, which utilizes a new digital platform to help pregnant women with overweight or obesity manage their gestational weight gain. The study will involve 144 participants who will be randomized into either the intervention group or a control group, with assessments conducted both in-person and remotely. Participants will track their weight, physical activity, and complete online surveys to provide data on their behaviors and outcomes. The study seeks to determine the intervention's impact on weight management, maternal-infant health, and the feasibility of implementing this approach in various healthcare settings.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18-45 years with a BMI between 24.0 and 45.0, who are between 8 and 18 weeks gestation.
Not a fit: Patients who are not overweight or obese, or those with contraindications to physical activity, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could help pregnant women manage their weight more effectively, leading to improved health outcomes for both mothers and infants.
How similar studies have performed: Previous studies have shown promise in managing gestational weight gain through digital interventions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
University Park, Pennsylvania
- Pennsylvania State University — University Park, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Abigail Pauley, PhD
- Email: amp34@psu.edu
- Phone: 814-865-0840
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.