Prenatal Starting Early Program: Randomized Controlled Trial of an mHealth Intervention in Prenatal Care and Wic to Improve Nutrition and Physical Activity During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 276
- 试验地点
- 2
- 主要终点
- Total amount of screen time
研究概览
简要总结
The purpose of this interventional trial is to test the efficacy of the remote delivery of the StEP:Prenatal intervention compared to standard prenatal care in pregnant individuals planning to receive prenatal and pediatric care at Bellevue Hospital. The primary aims are to determine the efficacy of the remotely delivered StEP:Prenatal intervention on diet, lifestyle behaviors, social determinants of health (SDoH), and pregnancy outcomes.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Currently pregnant in the first trimester (up to 13 weeks, 6 days)
- •Speak English or Spanish fluently
- •Intent to receive prenatal and pediatric care at Bellevue
- •≥18 years
- •Have a smart phone or device with internet access
- •Willing and able to provide consent
排除标准
- •Severe illness (severe medical or mental health condition e.g. cancer, epilepsy neuromuscular disease, psychosis or bipolar disorder).
- •Note: Diabetes, hypertension, depression are not excluded.
- •Living in a shelter
- •Receiving treatment for drug or alcohol use
研究组 & 干预措施
Routine Care + StEP:Prenatal
Participants will receive routine care and up to 8 StEP:Prenatal sessions. Routine care will follow through the post-partum period.
干预措施: StEP:Prenatal (Behavioral)
Routine Care + StEP:Prenatal
Participants will receive routine care and up to 8 StEP:Prenatal sessions. Routine care will follow through the post-partum period.
干预措施: Routine Care (Other)
Routine Care
Participants will receive routine care during pregnancy and the post-partum period.
干预措施: Routine Care (Other)
结局指标
主要结局
Total amount of screen time
时间窗: 3 months (6-14 weeks postpartum)
Self-reported using survey items from the Behavioral Risk Factor Surveillance System (BRFSS). The questions are related to daily activities, physical activities, and sedentary activities.
Daily servings of fruits (cup equivalents)
时间窗: 3 months (6-14 weeks postpartum)
As Measured by the Diet History Questionnaire (DHQ) III. The DHQ III consists of 135 food and beverage line items and 26 dietary supplement questions. Self-reported by each participant via DHQ III.
Daily servings of refined grains (ounce equivalents)
时间窗: 3 months (6-14 weeks postpartum)
As Measured by the Diet History Questionnaire (DHQ) III. The DHQ III consists of 135 food and beverage line items and 26 dietary supplement questions. Self-reported by each participant via DHQ III.
Number of times 100% pure fruit juice consumed
时间窗: 3 months (6-14 weeks postpartum)
Self-reported using survey items from the Behavioral Risk Factor Surveillance System (BRFSS). The question is related to 100% fruit juice consumed during the past 30 days.
Healthy Eating Index (HEI)-2015 score
时间窗: 3 months (6-14 weeks postpartum)
The HEI-2015 measures 13 components (9 adequacy \[total fruits, whole fruits, total vegetables, greens and beans, whole grains, dairy, total protein foods, seafood and plant proteins, fatty acids\], and 4 moderation \[refined grains, sodium, saturated fat, added sugars\]. For the adequacy components, higher scores indicate higher intakes. For the moderation components, higher scores reflect lower intakes. Scores for each component are summed to create a total maximum HEI-2020 score of 100 points, with a higher score reflecting a dietary pattern that better aligns with the dietary guidelines. HEI scores range from 0 to 100, with higher scores indicating better diet quality. HEI scores \> 80 indicate a "good" diet, scores ranging from 51 to 80 reflect a diet that "needs improvement," and HEI scores \< 51 imply a "poor" diet (7).
Daily servings of protein foods (ounce equivalents)
时间窗: 3 months (6-14 weeks postpartum)
As Measured by the Diet History Questionnaire (DHQ) III. The DHQ III consists of 135 food and beverage line items and 26 dietary supplement questions. Self-reported by each participant via DHQ III.
Daily servings of whole grains (ounce equivalents)
时间窗: 3 months (6-14 weeks postpartum)
As Measured by the Diet History Questionnaire (DHQ) III. The DHQ III consists of 135 food and beverage line items and 26 dietary supplement questions. Self-reported by each participant via DHQ III.
Daily servings of vegetables (cup equivalents)
时间窗: 3 months (6-14 weeks postpartum)
As Measured by the Diet History Questionnaire (DHQ) III. The DHQ III consists of 135 food and beverage line items and 26 dietary supplement questions. Self-reported by each participant via DHQ III.
Number of times sugar sweetened beverages (not including 100% fruit juice) consumed
时间窗: 3 months (6-14 weeks postpartum)
Self-reported using survey items from the Behavioral Risk Factor Surveillance System (BRFSS). The questions are related to sugar sweetened beverages (not including 100% fruit juice) consumed during the past 30 days.
Daily servings of dairy (total milk cup equivalents)
时间窗: 3 months (6-14 weeks postpartum)
As Measured by the Diet History Questionnaire (DHQ) III. The DHQ III consists of 135 food and beverage line items and 26 dietary supplement questions. Self-reported by each participant via DHQ III.
Total amount of physical activity
时间窗: 3 months (6-14 weeks postpartum)
Self-reported using survey items from the Behavioral Risk Factor Surveillance System (BRFSS). The questions are related to daily activities, physical activities, and sedentary activities.
次要结局
- Gestational weight gain(3 months (6-14 weeks postpartum))
- Total number of pregnancy care visits attended(3 months (6-14 weeks postpartum))
- Patient Health Questionnaire (PHQ-9) score(3 months (6-14 weeks postpartum))
- Perceived Stress Scale score(3 months (6-14 weeks postpartum))
- Generalized Anxiety Disorder-7 score(3 months (6-14 weeks postpartum))
- Family Resilience score(3 months (6-14 weeks postpartum))
- Total number of remote StEP:Prenatal sessions attended(3 months (6-14 weeks postpartum))