Targeting Pregnancy-related Weight Gain to Reduce Disparities in Obesity: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 262
- 试验地点
- 2
- 主要终点
- Change in maternal weight from early pregnancy to 6 months and 1 year postpartum
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Usual Care
The Usual Obstetric Care group will receive usual advice about nutrition and activity during pregnancy from their obstetrician along with some additional information about pregnancy and childbirth through readings from The American College of Obstetricians and Gynecologists. In addition, participants will receive weekly text messages to maintain contact and ensure follow-up.
Healthy Lifestlye Group
The Healthy Lifestyle Group will take part in an individual, technology-based behavioral intervention program which will include specific information about nutrition and physical activity, and strategies for helping them make changes to their diet, physical activity, and weight-related behaviors during pregnancy. Participants will receive information through print materials, text messages, a private Facebook group, and in-person visits and phone calls from a health coach who is part of our research team.
干预措施: Healthy Lifestyle Group (Behavioral)
结局指标
主要结局
Change in maternal weight from early pregnancy to 6 months and 1 year postpartum
时间窗: Approximately 18 months
次要结局
- 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)