Prenatal Starting Early Program: Randomized Controlled Trial of an mHealth Intervention in Prenatal Care and Wic to Improve Nutrition and Physical Activity During Pregnancy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pregnancy
- Sponsor
- NYU Langone Health
- Enrollment
- 276
- Locations
- 1
- Primary Endpoint
- Total amount of screen time
- Status
- Active, Not Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Total amount of screen time
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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))