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 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT03146156
Eligibility Criteria:
Inclusion criteria:
All subjects will have had by the time of randomization at 3 months postpartum:
1. Planning another pregnancy within the next 24 months
2. Planning to deliver at Tufts medical center during their next pregnancy
3. A previous full-term singleton pregnancy (gestational age \> 37 weeks)
4. 18 to 40 years of age at the time of enrollment into the study
5. Vaginal or cesarean delivery
6. Normal glucose tolerance or gestational diabetes (GDM), but without evidence of postpartum diabetes as defined by a 75 g 2-hr oral glucose tolerance test (OGTT)
7. Normal blood pressure or mild preeclampsia but normal postpartum blood pressure
8. Bottle or breast feeding
9. Normal thyroid function (determined by TSH concentration in blood), normal cell blood count and normal kidney and liver functions. Lipid profile with triglyceride levels not higher than 400 mg/dl (fasting) and LDL levels less than 180 mg/dL
10. No clinical signs or symptoms of cardiovascular disease or any other disease or condition that may contraindicate participation in exercise training (i.e. COPD, severe asthma, orthopedic abnormalities)
11. Using contraception
Exclusion criteria:
1. Pre or post-delivery diabetes
2. Post-delivery hypertension requiring medication
3. asthma requiring more than occasional use of a sympathomimetic inhaler, but not chronic inhaled steroids
4. Inflammatory bowel disease
5. Need for assisted reproductive technologies to become pregnant
6. Medical or obstetrical contraindication to the defined exercise program or diet
7. Tobacco, excessive alcohol use (greater than 2 drinks/day) or illicit drug use
8. Eating disorders such as bulimia
9. Gastric surgery to lose weight including banding or bypass procedures
10. Any psychological or psychiatric condition which may impair participation in the lifestyle intervention program
11. Multiple pregnancy
12. HIV, or hepatitis B or C
13. If a LIPP subject becomes pregnant prior to 16 weeks after randomization before the weight- loss phase for the lifestyle intervention is completed or a control subject becomes pregnant before the 3 month postpartum randomization, i.e. no baseline measurement.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT03146156
Study Brief:
Protocol Section:
NCT03146156