Prenatal Starting Early Program mHealth

NCT06087133 | Active Not Recruiting

• 1 other identifier: 23-00902
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

Prenatal care

Outcome Measures

Primary Outcomes (22)

• Daily servings of fruits (cup equivalents)

  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.

  Week 28-42 (third trimester)

• Daily servings of whole grains (ounce equivalents)

  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.

  Week 28-42 (third trimester)

• Daily servings of refined grains (ounce equivalents)

  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.

  Week 28-42 (third trimester)

• Daily servings of dairy (total milk cup equivalents)

  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.

  Week 28-42 (third trimester)

• Daily servings of vegetables (cup equivalents)

  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.

  Week 28-42 (third trimester)

• Number of times 100% pure fruit juice consumed

  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.

  Week 28-42 (third trimester)

• Number of times sugar sweetened beverages (not including 100% fruit juice) consumed

  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.

  Week 28-42 (third trimester)

• Daily servings of protein foods (ounce equivalents)

  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.

  Week 28-42 (third trimester)

• Healthy Eating Index (HEI)-2015 score

  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).

  Week 28-42 (third trimester)

• Daily servings of fruits (cup equivalents)

  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.

  3 months (6-14 weeks postpartum)

• Daily servings of whole grains (ounce equivalents)

  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.

  3 months (6-14 weeks postpartum)

• Daily servings of refined grains (ounce equivalents)

  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.

  3 months (6-14 weeks postpartum)

• Daily servings of dairy (total milk cup equivalents)

  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.

  3 months (6-14 weeks postpartum)

• Daily servings of vegetables (cup equivalents)

  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.

  3 months (6-14 weeks postpartum)

• Daily servings of protein foods (ounce equivalents)

  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.

  3 months (6-14 weeks postpartum)

• Number of times 100% pure fruit juice consumed

  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.

  3 months (6-14 weeks postpartum)

• Number of times sugar sweetened beverages (not including 100% fruit juice) consumed

  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.

  3 months (6-14 weeks postpartum)

• Healthy Eating Index (HEI)-2015 score

  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).

  3 months (6-14 weeks postpartum)

• Total amount of screen time

  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.

  Week 28-42 (third trimester)

• Total amount of physical activity

  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.

  Week 28-42 (third trimester)

• Total amount of screen time

  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.

  3 months (6-14 weeks postpartum)

• Total amount of physical activity

  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.

  3 months (6-14 weeks postpartum)

Secondary Outcomes (11)

• Patient Health Questionnaire (PHQ-9) score

  Week 28-42 (third trimester)

• Patient Health Questionnaire (PHQ-9) score

  3 months (6-14 weeks postpartum)

• Generalized Anxiety Disorder-7 score

  Week 28-42 (third trimester)

• Generalized Anxiety Disorder-7 score

  3 months (6-14 weeks postpartum)

• Perceived Stress Scale score

  Week 28-42 (third trimester)

Study Arms (2)

Routine Care + StEP:Prenatal

EXPERIMENTAL

Participants will receive routine care and up to 8 StEP:Prenatal sessions. Routine care will follow through the post-partum period.

Behavioral: StEP:Prenatal; Other: Routine Care

Routine Care

ACTIVE COMPARATOR

Participants will receive routine care during pregnancy and the post-partum period.

Other: Routine Care

Interventions

StEP:Prenatal BEHAVIORAL

StEP is a health care-based intervention based on elements of Social Cognitive Theory, in which registered dietitians with additional certified lactation counselor training (RD/CLC) provide individual and group-based support for healthy diet, physical activity, other lifestyle behaviors, stress reduction, and healthy gestational weight gain. StEP:Prenatal will be delivered remotely. There are up to 8 sessions scheduled around the routine prenatal care visits and designed to be offered from the first trimester of pregnancy through delivery.

Routine Care + StEP:Prenatal

Routine Care OTHER

Routine care includes routine prenatal and post-partum primary care visits, on-site WIC services and referrals for additional services as needed (e.g., women with poor weight gain, obesity, or diabetes may be offered additional nutrition visits).

Routine Care; Routine Care + StEP:Prenatal

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• United States Department of Agriculture (USDA): collaborator

Study Sites (1)

NYC Health + Hospitals/Bellevue

New York, New York, 10016, United States

Location

Study Officials

• Mary Messito, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 17, 2023
• Study Start: December 8, 2023
• Primary Completion: April 14, 2026
• Study Completion: April 14, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to Mary.Messito@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)