Behavioral, Obesity, Pregnancy, Weight Loss
Conditions
Keywords
Pregnancy, Postpartum, Weight Retention, Behavioral, Electronically-mediated
Brief summary
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.
Detailed description
Black women are in particular need for obesity prevention and treatment. Targeting the childbearing period has the potential to slow the accumulation of weight gain among this high risk group. Previous interventions to prevent postpartum weight retention among Blacks are sparse and limited by poor intervention adherence, high attrition, and failure to include pregnancy in the study design. The proposed research aims to overcome these shortcomings by developing an intervention that 1) focuses solely on Black women, 2) incorporates Black mothers' information needs, values, and social context, 3) uses technology to facilitate participant engagement, and 4) includes both the pregnancy and postpartum periods.
Interventions
BEHAVIORALHealthy Lifestyle Group
Electronically-mediated, behavioral intervention during and after pregnancy encouraging mothers to eat healthy, exercise, and return to their early pregnancy weights by 1 year postpartum
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Temple University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Pregnant African-American women at least 18 years of age 2. BMI at recruitment between 25.0-44.9 kg/m2 3. Singleton pregnancy 4. Gestational age of ≤ 20 weeks as determined by last menstrual period 5. Plan to carry the pregnancy to term and keep the baby 6. Own a cell phone with a text messaging plan 7. Member of Facebook social networking site 8. Able to participate in physical activity 9. Participants must be willing to comply with all study-related procedures
Exclusion criteria
1. BMI ≤ 24.9 or ≥ 45.0 2. 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. 3. Known atherosclerotic cardiovascular disease 4. Known congestive heart failure 5. Known diabetes mellitus (type 1 or type 2) 6. Uncontrolled thyroid disease. Participants with controlled thyroid disease on medication for at least three months are allowable. 7. Known cancer 8. Any major active rheumatologic, pulmonary, hepatic, dermatologic disease or inflammatory condition requiring steroids or immune modulating medications 9. History of testing HIV positive 10. Current smoker or tobacco user 11. Current or recent history (past 6 months) of drug or alcohol abuse or dependence 12. Participation in any weight control or investigational drug study within 6 weeks of screening 13. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety for successful study participation 14. Gastrointestinal Disorders (gallbladder disease, Crohn's disease, etc) 15. Previous weight loss surgery 16. History of bulimia or anorexia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in maternal weight from early pregnancy (< 20 weeks gestation) to 6 months and 1 year postpartum | Approximately 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in maternal weight from early pregnancy to delivery | Approximately 6 months |
| Change in maternal cardiometabolic biomarkers and additional anthropometrics (insulin sensitivity and secretion, fasting lipids, blood pressure, waist circumference) 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 |
Countries
United States
Outcome results
None listed