Prenatal Starting Early Program mHealth

Prenatal Starting Early Program: Randomized Controlled Trial of an mHealth Intervention in Prenatal Care and Wic to Improve Nutrition and Physical Activity During Pregnancy

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pregnancy
• Intervention / Treatment: Behavioral: StEP:Prenatal; Other: Routine Care

• Study Type: Interventional
• Enrollment (Actual): 276
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYC Health + Hospitals/Bellevue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: StEP:Prenatal; 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.; Other: Routine Care; 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).
Active Comparator: Routine Care; Participants will receive routine care during pregnancy and the post-partum period.	Other: Routine Care; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire (PHQ-9) score	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).	Week 28-42 (third trimester)
Patient Health Questionnaire (PHQ-9) score	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).	3 months (6-14 weeks postpartum)
Generalized Anxiety Disorder-7 score	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).	Week 28-42 (third trimester)
Generalized Anxiety Disorder-7 score	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).	3 months (6-14 weeks postpartum)
Perceived Stress Scale score	Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.	Week 28-42 (third trimester)
Perceived Stress Scale score	Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.	3 months (6-14 weeks postpartum)
Gestational weight gain		3 months (6-14 weeks postpartum)
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)
Family Resilience score	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.	Week 28-42 (third trimester)
Family Resilience score	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.	3 months (6-14 weeks postpartum)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: United States Department of Agriculture (USDA)
• Investigators: Principal Investigator: Mary Messito, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2023
• Primary Completion (Estimated): April 14, 2026
• Study Completion (Estimated): April 14, 2026

Study Registration Dates

• First Submitted: October 11, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 8, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Prenatal care
• Other Study ID Numbers: 23-00902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Mary.Messito@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No