PregnancyNCT06087133
Prenatal Starting Early Program mHealth
A study testing StEP:Prenatal and Routine Care in people with Pregnancy, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- StEP:Prenatal and Routine Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2023to 31 Oct 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
NYC Health + Hospitals/Bellevue
New York, New York, 10016
About this study
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
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
- Being tested
- StEP:Prenatal, Routine Care
- Keywords
- Prenatal care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StEP:PrenatalBehavioural
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 CareOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: StEP:Prenatal; Other: Routine Care |
| Routine Care | Active comparator | Participants will receive routine care during pregnancy and the post-partum period. Receives: Other: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months (6-14 weeks postpartum)
Secondary outcomes (11)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months (6-14 weeks postpartum)
Gestational weight gain
Measured: 3 months (6-14 weeks postpartum)
Total number of remote StEP:Prenatal sessions attended
Measured: 3 months (6-14 weeks postpartum)
Total number of pregnancy care visits attended
Measured: 3 months (6-14 weeks postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start8 Dec 2023
- Primary completion14 Apr 2026
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Sponsor
- Investigators
- Mary Messito, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087133
- Sponsor's protocol ID
- 23-00902
- Status last verified
- Jun 2026
- First submitted
- 11 Oct 2023
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.