NCT05807594 Healthy Mom Zone Gestational Weight Gain Management Intervention 2.0
| NCT ID | NCT05807594 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Penn State University |
| Condition | Gestational Weight Gain |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2023-11-27 |
| Primary Completion | 2028-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 144 participants in total. It began in 2023-11-27 with a primary completion date of 2028-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05807594 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Gestational Weight Gain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05807594 currently recruiting?
Yes, NCT05807594 is actively recruiting participants. Contact the research team at amp34@psu.edu for enrollment information.
Where is the NCT05807594 trial being conducted?
This trial is being conducted at University Park, United States.
Who is sponsoring the NCT05807594 clinical trial?
NCT05807594 is sponsored by Penn State University. The trial plans to enroll 144 participants.