Targeting Pregnancy-related Weight Gain to Reduce Disparities in Obesity: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pregnancy
- Sponsor
- Temple University
- Enrollment
- 262
- Locations
- 1
- Primary Endpoint
- Change in maternal weight from early pregnancy to 6 months and 1 year postpartum
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
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
- •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
Outcomes
Primary Outcomes
Change in maternal weight from early pregnancy to 6 months and 1 year postpartum
Time Frame: Approximately 18 months
Secondary Outcomes
- 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)