Status:
COMPLETED
Targeting Pregnancy-related Weight Gain to Reduce Disparities in Obesity
Lead Sponsor:
Temple University
Collaborating Sponsors:
HRSA/Maternal and Child Health Bureau
Conditions:
Pregnancy
Body Weight Changes
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to find out whether a technology-base healthy lifestyle program is an acceptable and effective way for African-American mothers to improve their eating and activity during...
Detailed Description
Black women are in particular need for obesity prevention and treatment. The childbearing period represents a critical life stage of heightened vulnerability for new or persistent obesity, especially ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2019
Estimated Enrollment :
262 Patients enrolled
Trial Details
Trial ID
NCT02229708
Start Date
September 1 2014
End Date
July 17 2019
Last Update
October 17 2019
Active Locations (1)
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1
Temple University
Philadelphia, Pennsylvania, United States, 19140