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:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT03945266
Eligibility Criteria:
Inclusion Criteria:
* Pregnant women
* Overweight or obese \[body mass index range 24- \>40 (if BMI (kg/m\^2) is \> 40, consultation with woman's health care provider (PCP/OBGYN) will be made to determine eligibility and ensure she does not have any contraindications to exercise) PI Danielle Downs will have communication with Dr. Hovick from MNPG to give information on the woman. The investigators also have a physician consent form (see Physician Patient Consent to Participate in documents) that the physician will complete as to whether the woman is eligible or not eligible to participate.
* Normal weight women with a BMI range of 18.0 to 23.9 can be enrolled in to the study as control participants (same measures of data collection, no opportunity for intervention).
* Ages 18-40 years \[based on pilot data this group comprises \>85% of the live births in Central Pennsylvania\]
* 1st, 2nd or 3rd pregnancy 6-16 weeks gestation
* Able to read, understand, and speak English
* Residing in and around State College, PA
* 1st and 2nd time pregnant mothers \[none or one other live or still born, biological children \> 25 weeks gestation prior to this pregnancy; it may be conceivable that a woman has a blended family due to a mixed marriage and she will not be excluded if she is a parent to a guardian, foster child, or step child\]
* Access to a computer or willingness to come onsite to complete study materials
* Infants born to participants who are 6-10 weeks old
Exclusion Criteria:
* Having more than one live or stillborn child \> 25 weeks gestation; late-term pregnancy loss
* Diabetes at study entry \[while future adaptations of this study will target women with diabetes, for the pilot study, they will be excluded to control for this confound\]
* Contraindications to exercise in pregnancy \[Hemodynamically significant heart disease, Restrictive lung disease, Incompetent cervix/cerclage, Persistent second \[or third\] trimester bleeding, Placenta previa after 26 weeks of gestation, Premature labor during the current pregnancy, Ruptured membranes, Preeclampsia/pregnancy-induced hypertension\] per the ACOG guidelines \[ACOG Committee on Obstetric Practice. \[(2015, December). ACOG Committee opinion. Number 650: Physical Activity and Exercise During Pregnancy and the Postpartum Period. Obstetrics and Gynecology, 126,(6), 135-142\].
* Having a body mass index less than 18 or over 40 (exclusion only if physician doesn't provide consent for BMI is over 40)
* Not planning to live in the area for the study duration
* Severe allergies or dietary restrictions that would preclude eating healthy foods
* Not able to read, understand, and/or speak English
* Cognitively impaired
* Currently smoking
* Infants not born to participants
* Infants younger than 6 weeks old
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT03945266
Study Brief:
Protocol Section:
NCT03945266