Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT05807594
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
* Overweight or obese: body mass index (BMI) range 24.0 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 24.0-45.0
* 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)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05807594
Study Brief:
Protocol Section:
NCT05807594