Prenatal Starting Early Program mHealth

Not Applicable

Recruiting

• Conditions: Pregnancy
• Interventions: Other: Routine Care

• Registration Number: NCT06087133
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-11
• Study First Submitted QC: 2023-10-11
• Study First Posted: 2023-10-17
• Study Start: 2023-12-08
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Primary Completion: 2026-04-14
• Study Completion: 2026-04-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine Care	Routine Care	Participants will receive routine care during pregnancy and the post-partum period.
Routine Care + StEP:Prenatal	Routine Care	Participants will receive routine care and up to 8 StEP:Prenatal sessions. Routine care will follow through the post-partum period.

Primary Outcome Measures

Name	Time	Method
Total amount of screen time	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)	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)	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	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	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 whole grains (ounce equivalents)	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)	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	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 protein foods (ounce equivalents)	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 dairy (total milk cup equivalents)	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	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 Outcome Measures

Name	Time	Method
Gestational weight gain	3 months (6-14 weeks postpartum)
Patient Health Questionnaire (PHQ-9) score	3 months (6-14 weeks postpartum)	Patient Health Questionnaire-9 (PHQ-9) measures depressive symptoms and consists of 9 items.; The PHQ-9 total score ranges from 0 to 27 (scores of 5-9 are classified as mild depressive symptoms; 10-14 as moderate depressive symptoms; 15-19 as moderately severe depressive symptoms; ≥ 20 as severe depressive symptoms).
Perceived Stress Scale score	3 months (6-14 weeks postpartum)	Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Generalized Anxiety Disorder-7 score	3 months (6-14 weeks postpartum)	Generalized Anxiety Disorder-7 score (GAD-7) measures anxiety symptoms and consists of 7 items.; The GAD-7 total score ranges from 0 to 21 (scores of 0-4 are classified as minimal anxiety symptoms; 5-9 as mild anxiety symptoms; 10-14 as moderate anxiety symptoms; 15-21 as severe anxiety symptoms).
Family Resilience score	3 months (6-14 weeks postpartum)	An overall family resilience score is calculated using the mean from each of the participants' responses to the 4 items. Scores range from 0 to 4. Higher scores indicate greater family resilience.
Total number of remote StEP:Prenatal sessions attended	3 months (6-14 weeks postpartum)
Total number of pregnancy care visits attended	3 months (6-14 weeks postpartum)

Trial Locations

Locations (1)

NYC Health + Hospitals/Bellevue; 🇺🇸 New York, New York, United States