Pregnancy
Conditions
Keywords
Prenatal care
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.
Interventions
BEHAVIORALStEP: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.
OTHERRoutine 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).
Sponsors
NYU Langone Health
United States Department of Agriculture (USDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily servings of fruits (cup equivalents) | Week 28-42 (third trimester) | 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. |
| Daily servings of whole grains (ounce equivalents) | Week 28-42 (third trimester) | 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. |
| Daily servings of refined grains (ounce equivalents) | Week 28-42 (third trimester) | 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. |
| Daily servings of dairy (total milk cup equivalents) | Week 28-42 (third trimester) | 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. |
| Daily servings of vegetables (cup equivalents) | Week 28-42 (third trimester) | 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. |
| Number of times 100% pure fruit juice consumed | Week 28-42 (third trimester) | 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. |
| Number of times sugar sweetened beverages (not including 100% fruit juice) consumed | Week 28-42 (third trimester) | 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. |
| Daily servings of protein foods (ounce equivalents) | Week 28-42 (third trimester) | 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. |
| Healthy Eating Index (HEI)-2015 score | Week 28-42 (third trimester) | 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). |
| Total amount of screen time | Week 28-42 (third trimester) | 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. |
| Total amount of physical activity | Week 28-42 (third trimester) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire (PHQ-9) score | Week 28-42 (third trimester) | 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). |
| Generalized Anxiety Disorder-7 score | Week 28-42 (third trimester) | 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). |
| Perceived Stress Scale score | Week 28-42 (third trimester) | Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. |
| Family Resilience score | Week 28-42 (third trimester) | 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. |
| 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) | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMary Messito, MD
NYU Langone Health
Outcome results
None listed