Prenatal Starting Early Program mHealth

Study Overview
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Brief Summary
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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.

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

Conditions
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Pregnancy

Intervention / Treatment
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* Behavioral: StEP:Prenatal
* Other: Routine Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Routine Care + StEP:Prenatal<br>Participants will receive routine care and up to 8 StEP:Prenatal sessions. Routine care will follow through the post-partum period. | Behavioral: StEP:Prenatal<br>* 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.<br>Other: Routine Care<br>* 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).<br>|
| Active Comparator: Routine Care<br>Participants will receive routine care during pregnancy and the post-partum period. | Other: Routine Care<br>* 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).<br>|

What is the study measuring?
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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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prenatal care