An interventional study of StEP:Prenatal and Routine Care in Pregnancy, sponsored by NYU Langone Health. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Prevention
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.
NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Note: Diabetes, hypertension, depression are not excluded.
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
Participants will receive routine care during pregnancy and the post-partum period.
Other: Routine Care
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 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).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months (6-14 weeks postpartum)
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months (6-14 weeks postpartum)
Gestational weight gain
Time frame: 3 months (6-14 weeks postpartum)
Total number of remote StEP:Prenatal sessions attended
Time frame: 3 months (6-14 weeks postpartum)
Total number of pregnancy care visits attended
Time frame: 3 months (6-14 weeks postpartum)
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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