Healthy Mom Zone Gestational Weight Gain Management Intervention 2.0
Efficacy of a Novel Digital Platform to Scale-Up a Personalized Prenatal Weight Gain Intervention Using Control Systems Methodology
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 45 Years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "Subjects will have access to REDCap (Research Electronic Data Capture), a secure, web-based application to complete online surveys for social cognitive outcomes for PA and EI (eating healthy/ limiting unhealthy foods), and sleep and eating behaviors."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether the Healthy Mom Zone 2.0 program and digital tools help women manage weight gain during pregnancy. It also looks at sleep, eating habits, and health outcomes for mothers and babies. It is for pregnant women ages 18–45 who meet the study’s weight and health rules.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be pregnant with one baby and at least 8 but less than 18 weeks pregnant at screening.
- Be 18–45 years old. Women of any race or ethnic group may join, whether or not they have been pregnant before.
- Have a body mass index (BMI), a measure of weight compared with height, of 20–45. A BMI over 40 needs review by your health care provider.
- Have gained less than 25% of the total pregnancy weight gain recommended for you before joining.
- Have your doctor’s approval and meet the study’s rules for safe exercise during pregnancy.
- Be able to read, understand, and speak English.
- Have access to a computer or phone and be willing and able to complete study tasks and sessions electronically, at home, or at the study sites.
- Smoke no more than 20 cigarettes a day, take no weight-loss drugs, have no planned weight-loss surgery during pregnancy, and be in no other study or program that affects weight control.
Who can't join
- Not pregnant, pregnant with more than one baby, or outside the study’s age, pregnancy-week, BMI, or weight-gain limits.
- Unable to read or understand English, or unable to access study materials by computer or phone.
- Smoke more than 20 cigarettes a day, use weight-loss drugs, join another program that affects weight control, or plan weight-loss surgery during pregnancy.
- Have certain serious heart or lung diseases, severe anemia (too few healthy red blood cells), poorly controlled long-term high blood pressure, or poorly controlled type 1 diabetes.
- Have certain pregnancy problems, such as a weak or stitched-closed cervix, ongoing bleeding later in pregnancy, a placenta covering the cervix after 26 weeks, early labor, broken waters, or preeclampsia (a pregnancy-related high blood pressure condition).
- Without your provider’s approval: have an unchecked irregular heartbeat, long-term bronchitis, BMI over 40, a history of very little physical activity, or a baby growing too slowly in the womb.
- Without your provider’s approval: have a current eating disorder, severe food allergies, or diet limits that could prevent taking part.
- Without your provider’s approval: have severe poorly controlled asthma, bone or joint limits, poorly controlled seizures or thyroid disease, or an uncontrolled sleep disorder.
Simplified for readability. The official criteria below are what the study team uses.
Official 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)
Study sites (1)
PA
- Pennsylvania State University · University Park, PA 16802Abigail M Pauley, PhD · Study contact · 814-865-0840 · amp34@psu.eduDanielle Symons Downs, PhD · Principal investigatorMore trials in University Park