Behavioral, Body Weight Changes, Obesity, Pregnancy
Conditions
Keywords
Pregnancy, Weight control, Behavioral, technology-based intervention
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.
Interventions
BEHAVIORALHealthy Lifestyle Group
Sponsors
HRSA/Maternal and Child Health Bureau
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
* 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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in maternal weight from early pregnancy to 6 months and 1 year postpartum | Approximately 18 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed