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:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT02229708
Eligibility Criteria:
Inclusion Criteria:
* Pregnant African-American women at least 18 years of age
* BMI at recruitment between 25.0-44.9 kg/m2
* Singleton pregnancy
* Gestational age of ≤ 20 weeks as determined by last menstrual period
* Plan to carry the pregnancy to term and keep the baby
* Own a cell phone with a text messaging plan
* Member of Facebook social networking site
* Able to participate in physical activity
* Participants must be willing to comply with all study-related procedures
Exclusion Criteria:
* 1\. BMI ≤ 24.9 or ≥ 45.0
* Uncontrolled hypertension (systolic blood pressure \> 160 or diastolic blood pressure \> 95 mmHg). Participants with controlled hypertension on medication for at least three months are allowable.
* Known atherosclerotic cardiovascular disease
* Known congestive heart failure
* Known diabetes mellitus (type 1 or type 2)
* Uncontrolled thyroid disease. Participants with controlled thyroid disease on medication for at least three months are allowable.
* Known cancer
* Any major active rheumatologic, pulmonary, hepatic, dermatologic disease or inflammatory condition requiring steroids or immune modulating medications
* History of testing HIV positive
* Current smoker or tobacco user
* Current or recent history (past 6 months) of drug or alcohol abuse or dependence
* Participation in any weight control or investigational drug study within 6 weeks of screening
* Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety for successful participation in the study
* Gastrointestinal Disorders (gallbladder disease, Crohn's disease, etc)
* Previous weight loss surgery
* History of bulimia or anorexia
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02229708
Study Brief:
Protocol Section:
NCT02229708