SmartMoms in WIC: A Smartphone Intervention for WIC Mothers to Improve Nutrition and Weight Gain During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 351
- 试验地点
- 2
- 主要终点
- Number of Women Who Have Appropriate Gestational Weight Gain
研究概览
简要总结
The study will test the effectiveness of a smartphone-based behavior modification program adapted for use in Women, Infants, and Children program in a state-wide, randomized controlled trial in 432 low-income women enrolled in the Louisiana Women, Infants, and Children program.
详细描述
The study is a multi-site randomized controlled trial, testing the effectiveness of the smartphone-based behavior modification program in pregnant women within the Louisiana Women, Infants, and Children program. Equal number of participants will be randomized to either the intervention or the control. Although the intervention itself lasts 24 weeks (only during pregnancy), women will be enrolled in this study for approximately 18 months, from the 10-16th week of pregnancy until 12 month postpartum follow-up. Study outcomes will be assessed at three visits during pregnancy (early, mid, and late,) and three visits postpartum (1, 6, and 12 months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Less than 16 weeks gestational age at screening visit
- •Have a BMI of 18.5 to 40 kg/m2
- •Expecting a singleton pregnancy
- •Certified to receive Women, Infants, and Children services during current pregnancy
- •Has smartphone with internet access
- •Willing to be identifiable to other study participants in this study program
排除标准
- •Drug or alcohol use
- •Non-pregnancy related illness
- •Hypertension at screening visit
- •Current mental health issue or eating disorder
- •Inability to complete a behavioral run-in task
- •Plans to move out of the state in the next 18 months
结局指标
主要结局
Number of Women Who Have Appropriate Gestational Weight Gain
时间窗: Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation)
Number of pregnant women who gain appropriate weight during pregnancy as recommended by the Institute of Medicine Gestational Weight Gain guidelines
次要结局
- Gestational Weight Gain Per Week(Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation))
- Total Gestational Weight Gain(Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation))
- Gestational Weight Gain Per Week(Approximately 6 months (from 10-16 weeks gestation to 35-38 weeks gestation))
研究者
Leanne Redman
Professor
Pennington Biomedical Research Center