Cluster Randomized Trial of a Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,335
- 试验地点
- 8
- 主要终点
- Total Gestational Weight Gain (GWG)
研究概览
简要总结
The aim of this trial is to investigate the effectiveness of a mobile health (mhealth) intervention to help overweight and obese women achieve appropriate gestational weight gain (GWG) for their pre-pregnancy body mass index (BMI). The goal of the intervention is to help women achieve GWG within the range recommended by the Institute of Medicine. The investigators propose an adaptive intervention that begins with an effective, yet low resource-intensive treatment and then provides incremental support and resources only to patients who need them. The intervention includes: 1) an mHealth tool allowing data to be automatically transmitted to a mobile website; 2) personalized text messages; and 3) personalized 1:1 telephone coaching sessions. The latter more intensive components are reserved for patients whose GWG is not within the IOM guidelines. The lifestyle intervention will be delivered through 1 telephone counseling session with a study dietician trained in motivational interviewing techniques, as well as through technology-based tools, automated text messages and weekly e-mails of core lifestyle intervention sessions. Personalized text messages and 1:1 telephone coaching sessions will be given to those who are not meeting the GWG guidelines. The lifestyle intervention will be compared to usual medical care. Maternal outcomes will be assessed shortly before delivery and at 6 weeks postpartum. Infant birthweight and weight at one year will also be assessed.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women receiving prenatal care at Kaiser Permanente San Francisco and Oakland and whose obstetric care clinicians consent to participate;
- •Pregravid BMI 25 to <40 (as determined from a measured pregravid weight in electronic medical record);
- •Has access to a smartphone and Wi-Fi;
- •Provides informed consent to participate.
排除标准
- •Multiple births;
- •Planning to move out of the area during the study period;
- •Inability to speak, read, or understand English;
- •Placed on bed rest at time of enrollment; ->15 weeks' gestation at enrollment.
研究组 & 干预措施
Lifestyle Intervention
The goal of the intervention is to help women achieve GWG within the range recommended by the Institute of Medicine. The lifestyle intervention will be delivered through 1 telephone counseling session with a study dietician trained in motivational interviewing techniques, as well as through technology-based tools, automated text messages and weekly e-mails of core lifestyle intervention sessions. Personalized text messages and 1:1 telephone coaching sessions will be given to those who are not meeting the GWG guidelines.
干预措施: Lifestyle Intervention (Behavioral)
Usual Care - Control
Usual Medical Care
结局指标
主要结局
Total Gestational Weight Gain (GWG)
时间窗: From 10 gestational weeks until time of delivery (duration of up to 9 months)
Calculated as last measured pregnancy weight at the time of delivery minus measured weight at 10 gestational weeks
Rate of Total GWG
时间窗: From 10 gestational weeks until time of delivery (duration of up to 9 months)
Calculated as total gestational weight gain / (# of weeks between 10 gestational weeks and the time of delivery)
Proportion of Women Meeting the Institute of Medicine's GWG Recommendation
时间窗: From 10 gestational weeks until time of delivery (duration of up to 9 months)
Proportion of women meeting the IOM's GWG recommendation for weekly rate of GWG
次要结局
- Trimester-specific Weekly Rate of GWG(0 - 13 gestational weeks; 14 - 26 gestational weeks; 27 - 40 gestational weeks)
- GWG Trajectory Throughout Pregnancy(From 10 gestational weeks until time of delivery (duration of up to 9 months))
- Change in Moderate to Vigorous Physical Activity (in MET Hrs/Week) as Assessed by the Pregnancy Physical Activity Questionnaire (PPAQ)(Between 12 weeks and 33 weeks of pregnancy)
- Overall Diet Quality According to the Healthy Eating Index-2015 (HEI-2015)(Assessed at 12 weeks of pregnancy)
- Postpartum Weight Retention(Assessed at 6 weeks postpartum)
- The Proportion of Infants With Appropriate Birthweight (>10th and <90th Percentile of Sex-, Gestational Age-, and Racial/Ethnic-specific Distribution)(Assessed at birth)
- Infant Growth (BMI Z-score)(From birth to 12 months of age)