Phase
Condition
Diet And Nutrition
Obesity
Pregnancy
Treatment
Attention Control Intervention
HMZ 2.0 Intervention
Clinical Study ID
Ages 18-45 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Pregnant women
≥ 8 and < 18 weeks gestation at time of screening. This range of gestational age ischosen to: a) reduce chances of false pregnancy or miscarriage under 8 weeksgestation and b) recruit women in the 1st trimester for greatest impact of theintervention on gestational weight gain. In the feasibility and initial impactstudy, the investigators had less than 10% (n=3) miscarriages prior to randomizationusing 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 eligibilityand ensure she does not have any contraindications to physical activity or otherconcerns 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 sessionselectronically (e.g., email, Facetime, Zoom), at home (e.g., Zoom sessions deliveredsynchronous and asynchronous) or if requested by the participant, on-site at PennState University Park or Hershey campuses.
No current use of weight loss medications
No current participation in another interventional study or program that influencesweight control
No planned bariatric surgery during this current pregnancy
No absolute contraindications to exercise in pregnancy and relativecontraindications with provider consent (see below)
Exclusion
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-pregnancyto date of enrollment
Not able to read and/or understand English
Unable to access materials by computer or phone (even with data plan assistance ifnecessary)
Current use of weight loss medications
Current participation in another interventional study or program that influencesweight 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 studyparticipation.
Intrauterine growth restriction in current pregnancy
Poorly controlled respiratory disorder (severe asthma) that precludes studyparticipation
Orthopedic limitations
Poorly controlled seizure disorder
Poorly controlled thyroid disease
Uncontrolled sleep disorder (insomnia, sleep-disordered breathing)
Study Design
Study Description
Connect with a study center
Pennsylvania State University
University Park, Pennsylvania 16802
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.