Prenatal Starting Early Program mHealth

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06087133
• Other study ID #: 23-00902
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2023
• Est. completion date: April 14, 2026

Study information

• Verified date: December 2023
• Source: NYU Langone Health
• Contact: Mary Messito, MD
• Phone: 212-263-6424
• Email: Mary.Messito[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 14, 2026
• Est. primary completion date: April 14, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

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).

Locations

Country	Name	City	State
United States	NYC Health + Hospitals/Bellevue	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	United States Department of Agriculture (USDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Gestational weight gain		3 months (6-14 weeks postpartum)
Secondary	Total number of remote StEP:Prenatal sessions attended		3 months (6-14 weeks postpartum)
Secondary	Total number of pregnancy care visits attended		3 months (6-14 weeks postpartum)