Healthy4Baby: Preventing Postpartum Weight Retention Among Low-Income, Black Women
Completed · Phase 2
Conditions studied: Pregnancy, Weight Loss, Behavioral, Obesity
In brief
The purpose of this study is to assess the feasibility and efficacy of an electronically-mediated, pregnancy and postpartum, behavioral intervention program, compared to usual obstetric care, on changes in weight and cardiometabolic biomarkers among overweight and obese Black women.
Key facts
- Study ID
- NCT01530776
- Run by
- Temple University
- People needed
- 66
- Starts
- 2012-01-01
- Expected to finish
- 2016-03-01
- Last updated by the study team
- 2018-05-21
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 study participation
- Gastrointestinal Disorders (gallbladder disease, Crohn's disease, etc)
- Previous weight loss surgery
- History of bulimia or anorexia
Where it is running
- Temple University — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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