Targeting Pregnancy-related Weight Gain to Reduce Disparities in Obesity
- Conditions
- Body Weight ChangesBehavioralPregnancyObesity
- Registration Number
- NCT02229708
- Lead Sponsor
- Temple University
- 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 pregnancy, compared to usual obstetric care. The goal of the program is to enhance the health of African-American mothers and their babies.
- 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 among Black women, who retain 2-3 times more weight after pregnancy than White women. Pregnancy weight gain is the strongest identified risk factor for retaining a substantial amount of weight after pregnancy, yet few published interventions have been effective in reducing excessive weight gain in pregnancy, particularly among low-income Black mothers.
The proposed research aims to meets the needs of low-income, Black mothers by developing a novel pregnancy intervention that 1) focuses solely on Black women, 2) incorporates Black mothers' information needs, values, and social context, and 3) uses technology to facilitate participant engagement.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 262
- 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
-
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in maternal weight from early pregnancy to 6 months and 1 year postpartum Approximately 18 months
- Secondary Outcome Measures
Name Time Method Change in maternal cardiometabolic risk factors (glucose tolerance, blood pressure) from early pregnancy to 6 months and 1 year postpartum Approximately 18 months Change in infant weight and length from birth to 6 months and 1 year of age Approximately 12 months
Trial Locations
- Locations (1)
Temple University
🇺🇸Philadelphia, Pennsylvania, United States
Temple University🇺🇸Philadelphia, Pennsylvania, United States