Trial Outcomes & Findings for Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Feasibility Study (NCT NCT05940688)
NCT ID: NCT05940688
Last Updated: 2025-10-17
Results Overview
Participant acceptance is defined as a yes response to this question: "I would recommend the care I received to someone in a similar situation."
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
6 weeks postpartum
Results posted on
2025-10-17
Participant Flow
Participant milestones
| Measure |
Digital Health Intervention (DHI)
This group will receive routine prenatal care services. Additionally, those randomized to this arm will receive a DHI intervention. A modified DHI will be utilized that was developed by Memora Health in conjunction with EQUATE partners at UPenn and feedback from the POPPY Study Team and Community Advisory Board. All content is designed for 7th grade Flesch-Kincaid level or lower.
|
Community Health Worker (CHW)
Individuals randomized to this group will receive routine prenatal care services. Additionally, they will receive a CHW intervention. The CHW intervention will be adapted from an ongoing CHW program in Jefferson County, AL called "From Day One (FDO)", a comprehensive patient-centered program designed to educate and provide non-clinical, psychosocial, emotional support to expectant mothers from the 1st trimester of pregnancy through their child's first year of life. The intervention has been modified by the POPPY Study Team and Community Advisory Board.
|
DHI Plus CHW
This group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions.
|
Usual Care
This group will receive routine prenatal care services.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
11
|
10
|
|
Overall Study
COMPLETED
|
8
|
8
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Providing an Optimized and emPowered Pregnancy for You (PᵌOPPY) Feasibility Study
Baseline characteristics by cohort
| Measure |
Digital Health Intervention (DHI)
n=9 Participants
This group will receive routine prenatal care services. Additionally, those randomized to this arm will receive a DHI intervention. A modified DHI will be utilized that was developed by Memora Health in conjunction with EQUATE partners at UPenn and feedback from the POPPY Study Team and Community Advisory Board. All content is designed for 7th grade Flesch-Kincaid level or lower.
|
Community Health Worker (CHW)
n=10 Participants
Individuals randomized to this group will receive routine prenatal care services. Additionally, they will receive a CHW intervention. The CHW intervention will be adapted from an ongoing CHW program in Jefferson County, AL called "From Day One (FDO)", a comprehensive patient-centered program designed to educate and provide non-clinical, psychosocial, emotional support to expectant mothers from the 1st trimester of pregnancy through their child's first year of life. The intervention has been modified by the POPPY Study Team and Community Advisory Board.
|
DHI Plus CHW
n=11 Participants
This group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions.
|
Usual Care
n=10 Participants
This group will receive routine prenatal care services.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
30.8 years
n=5 Participants
|
29.5 years
n=7 Participants
|
29.1 years
n=5 Participants
|
24.9 years
n=4 Participants
|
29.1 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 weeks postpartumParticipant acceptance is defined as a yes response to this question: "I would recommend the care I received to someone in a similar situation."
Outcome measures
| Measure |
Digital Health Intervention (DHI)
n=9 Participants
This group will receive routine prenatal care services. Additionally, those randomized to this arm will receive a DHI intervention. A modified DHI will be utilized that was developed by Memora Health in conjunction with EQUATE partners at UPenn and feedback from the POPPY Study Team and Community Advisory Board. All content is designed for 7th grade Flesch-Kincaid level or lower.
|
Community Health Worker (CHW)
n=10 Participants
Individuals randomized to this group will receive routine prenatal care services. Additionally, they will receive a CHW intervention. The CHW intervention will be adapted from an ongoing CHW program in Jefferson County, AL called "From Day One (FDO)", a comprehensive patient-centered program designed to educate and provide non-clinical, psychosocial, emotional support to expectant mothers from the 1st trimester of pregnancy through their child's first year of life. The intervention has been modified by the POPPY Study Team and Community Advisory Board.
|
DHI Plus CHW
n=11 Participants
This group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions.
|
Usual Care
n=10 Participants
This group will receive routine prenatal care services.
|
|---|---|---|---|---|
|
Participant Acceptance of Randomization Arm / Intervention
Yes
|
8 Participants
|
8 Participants
|
10 Participants
|
7 Participants
|
|
Participant Acceptance of Randomization Arm / Intervention
Missing or Unknown
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Participant Acceptance of Randomization Arm / Intervention
No
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From randomization to 6 weeks postpartumPopulation: We did not collect data for this outcome as planned because the University legal department would not allow texting in the manner initially planned.
Use of the intervention for the digital health arm(s) is defined as the % of opened text messages. Use of the intervention for the community health worker arm(s) is defined as the % of planned sessions in which the participant engages with the community health worker.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization to study completion (up to 34 weeks)Number of perinatal care visits
Outcome measures
| Measure |
Digital Health Intervention (DHI)
n=9 Participants
This group will receive routine prenatal care services. Additionally, those randomized to this arm will receive a DHI intervention. A modified DHI will be utilized that was developed by Memora Health in conjunction with EQUATE partners at UPenn and feedback from the POPPY Study Team and Community Advisory Board. All content is designed for 7th grade Flesch-Kincaid level or lower.
|
Community Health Worker (CHW)
n=10 Participants
Individuals randomized to this group will receive routine prenatal care services. Additionally, they will receive a CHW intervention. The CHW intervention will be adapted from an ongoing CHW program in Jefferson County, AL called "From Day One (FDO)", a comprehensive patient-centered program designed to educate and provide non-clinical, psychosocial, emotional support to expectant mothers from the 1st trimester of pregnancy through their child's first year of life. The intervention has been modified by the POPPY Study Team and Community Advisory Board.
|
DHI Plus CHW
n=11 Participants
This group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions.
|
Usual Care
n=10 Participants
This group will receive routine prenatal care services.
|
|---|---|---|---|---|
|
Outpatient Perinatal Care Visits
|
13 Visits
Interval 11.0 to 14.0
|
9.5 Visits
Interval 6.5 to 11.0
|
9 Visits
Interval 4.5 to 10.5
|
12 Visits
Interval 10.5 to 12.0
|
SECONDARY outcome
Timeframe: At birthDelivery of a neonate at less than 37 weeks
Outcome measures
| Measure |
Digital Health Intervention (DHI)
n=9 Participants
This group will receive routine prenatal care services. Additionally, those randomized to this arm will receive a DHI intervention. A modified DHI will be utilized that was developed by Memora Health in conjunction with EQUATE partners at UPenn and feedback from the POPPY Study Team and Community Advisory Board. All content is designed for 7th grade Flesch-Kincaid level or lower.
|
Community Health Worker (CHW)
n=10 Participants
Individuals randomized to this group will receive routine prenatal care services. Additionally, they will receive a CHW intervention. The CHW intervention will be adapted from an ongoing CHW program in Jefferson County, AL called "From Day One (FDO)", a comprehensive patient-centered program designed to educate and provide non-clinical, psychosocial, emotional support to expectant mothers from the 1st trimester of pregnancy through their child's first year of life. The intervention has been modified by the POPPY Study Team and Community Advisory Board.
|
DHI Plus CHW
n=11 Participants
This group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions.
|
Usual Care
n=10 Participants
This group will receive routine prenatal care services.
|
|---|---|---|---|---|
|
Preterm Birth
Yes
|
2 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
|
Preterm Birth
No
|
7 Participants
|
7 Participants
|
7 Participants
|
7 Participants
|
|
Preterm Birth
Missing
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At birthWeight of neonate at birth
Outcome measures
| Measure |
Digital Health Intervention (DHI)
n=9 Participants
This group will receive routine prenatal care services. Additionally, those randomized to this arm will receive a DHI intervention. A modified DHI will be utilized that was developed by Memora Health in conjunction with EQUATE partners at UPenn and feedback from the POPPY Study Team and Community Advisory Board. All content is designed for 7th grade Flesch-Kincaid level or lower.
|
Community Health Worker (CHW)
n=10 Participants
Individuals randomized to this group will receive routine prenatal care services. Additionally, they will receive a CHW intervention. The CHW intervention will be adapted from an ongoing CHW program in Jefferson County, AL called "From Day One (FDO)", a comprehensive patient-centered program designed to educate and provide non-clinical, psychosocial, emotional support to expectant mothers from the 1st trimester of pregnancy through their child's first year of life. The intervention has been modified by the POPPY Study Team and Community Advisory Board.
|
DHI Plus CHW
n=11 Participants
This group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions.
|
Usual Care
n=10 Participants
This group will receive routine prenatal care services.
|
|---|---|---|---|---|
|
Neonatal Birthweight
|
3160.0 grams
Interval 2980.0 to 3480.0
|
3150.0 grams
Interval 2843.75 to 3577.5
|
2815.0 grams
Interval 2690.0 to 2990.0
|
2920.0 grams
Interval 2740.0 to 3060.0
|
SECONDARY outcome
Timeframe: At birthOccurrence of a cesarean birth
Outcome measures
| Measure |
Digital Health Intervention (DHI)
n=9 Participants
This group will receive routine prenatal care services. Additionally, those randomized to this arm will receive a DHI intervention. A modified DHI will be utilized that was developed by Memora Health in conjunction with EQUATE partners at UPenn and feedback from the POPPY Study Team and Community Advisory Board. All content is designed for 7th grade Flesch-Kincaid level or lower.
|
Community Health Worker (CHW)
n=10 Participants
Individuals randomized to this group will receive routine prenatal care services. Additionally, they will receive a CHW intervention. The CHW intervention will be adapted from an ongoing CHW program in Jefferson County, AL called "From Day One (FDO)", a comprehensive patient-centered program designed to educate and provide non-clinical, psychosocial, emotional support to expectant mothers from the 1st trimester of pregnancy through their child's first year of life. The intervention has been modified by the POPPY Study Team and Community Advisory Board.
|
DHI Plus CHW
n=11 Participants
This group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions.
|
Usual Care
n=10 Participants
This group will receive routine prenatal care services.
|
|---|---|---|---|---|
|
Cesarean Delivery
Cesarean
|
7 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
|
Cesarean Delivery
Vaginal
|
2 Participants
|
3 Participants
|
8 Participants
|
7 Participants
|
|
Cesarean Delivery
Missing
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At birthTransfusion of blood products
Outcome measures
| Measure |
Digital Health Intervention (DHI)
n=9 Participants
This group will receive routine prenatal care services. Additionally, those randomized to this arm will receive a DHI intervention. A modified DHI will be utilized that was developed by Memora Health in conjunction with EQUATE partners at UPenn and feedback from the POPPY Study Team and Community Advisory Board. All content is designed for 7th grade Flesch-Kincaid level or lower.
|
Community Health Worker (CHW)
n=10 Participants
Individuals randomized to this group will receive routine prenatal care services. Additionally, they will receive a CHW intervention. The CHW intervention will be adapted from an ongoing CHW program in Jefferson County, AL called "From Day One (FDO)", a comprehensive patient-centered program designed to educate and provide non-clinical, psychosocial, emotional support to expectant mothers from the 1st trimester of pregnancy through their child's first year of life. The intervention has been modified by the POPPY Study Team and Community Advisory Board.
|
DHI Plus CHW
n=11 Participants
This group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions.
|
Usual Care
n=10 Participants
This group will receive routine prenatal care services.
|
|---|---|---|---|---|
|
Maternal Blood Transfusion
Yes
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Maternal Blood Transfusion
No
|
8 Participants
|
8 Participants
|
10 Participants
|
8 Participants
|
|
Maternal Blood Transfusion
Missing
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Upon admission to the delivery-associated hospitalizationParticipant's self-reported intent of whether or not to express breast milk upon admission to the delivery-associated hospitalization
Outcome measures
| Measure |
Digital Health Intervention (DHI)
n=9 Participants
This group will receive routine prenatal care services. Additionally, those randomized to this arm will receive a DHI intervention. A modified DHI will be utilized that was developed by Memora Health in conjunction with EQUATE partners at UPenn and feedback from the POPPY Study Team and Community Advisory Board. All content is designed for 7th grade Flesch-Kincaid level or lower.
|
Community Health Worker (CHW)
n=10 Participants
Individuals randomized to this group will receive routine prenatal care services. Additionally, they will receive a CHW intervention. The CHW intervention will be adapted from an ongoing CHW program in Jefferson County, AL called "From Day One (FDO)", a comprehensive patient-centered program designed to educate and provide non-clinical, psychosocial, emotional support to expectant mothers from the 1st trimester of pregnancy through their child's first year of life. The intervention has been modified by the POPPY Study Team and Community Advisory Board.
|
DHI Plus CHW
n=11 Participants
This group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions.
|
Usual Care
n=10 Participants
This group will receive routine prenatal care services.
|
|---|---|---|---|---|
|
Breastfeeding Intent
Missing
|
0 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Breastfeeding Intent
Breastfeed only
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Breastfeeding Intent
Formula feed only
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Breastfeeding Intent
Both breast and formula feed
|
3 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
|
Breastfeeding Intent
Do not know yet
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Pregnancy through 6 weeks postpartum / 6 weeks of lifeThe number of mothers who received Tdap and infants who received the Hep B vaccine.
Outcome measures
| Measure |
Digital Health Intervention (DHI)
n=9 Participants
This group will receive routine prenatal care services. Additionally, those randomized to this arm will receive a DHI intervention. A modified DHI will be utilized that was developed by Memora Health in conjunction with EQUATE partners at UPenn and feedback from the POPPY Study Team and Community Advisory Board. All content is designed for 7th grade Flesch-Kincaid level or lower.
|
Community Health Worker (CHW)
n=10 Participants
Individuals randomized to this group will receive routine prenatal care services. Additionally, they will receive a CHW intervention. The CHW intervention will be adapted from an ongoing CHW program in Jefferson County, AL called "From Day One (FDO)", a comprehensive patient-centered program designed to educate and provide non-clinical, psychosocial, emotional support to expectant mothers from the 1st trimester of pregnancy through their child's first year of life. The intervention has been modified by the POPPY Study Team and Community Advisory Board.
|
DHI Plus CHW
n=11 Participants
This group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions.
|
Usual Care
n=10 Participants
This group will receive routine prenatal care services.
|
|---|---|---|---|---|
|
Vaccination Rate
Maternal TDAP · Accepted
|
7 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
|
Vaccination Rate
Maternal TDAP · Did not receive
|
2 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
|
Vaccination Rate
Maternal TDAP · Newborn Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Vaccination Rate
Newborn Hep. B · Accepted
|
6 Participants
|
6 Participants
|
6 Participants
|
7 Participants
|
|
Vaccination Rate
Newborn Hep. B · Did not receive
|
3 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
|
Vaccination Rate
Newborn Hep. B · Newborn Death
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From discharge from the delivery-associated hospitalization to 6 weeks postpartumAdmission of the mother to the hospital after discharge from the delivery-associated hospitalization
Outcome measures
| Measure |
Digital Health Intervention (DHI)
n=9 Participants
This group will receive routine prenatal care services. Additionally, those randomized to this arm will receive a DHI intervention. A modified DHI will be utilized that was developed by Memora Health in conjunction with EQUATE partners at UPenn and feedback from the POPPY Study Team and Community Advisory Board. All content is designed for 7th grade Flesch-Kincaid level or lower.
|
Community Health Worker (CHW)
n=10 Participants
Individuals randomized to this group will receive routine prenatal care services. Additionally, they will receive a CHW intervention. The CHW intervention will be adapted from an ongoing CHW program in Jefferson County, AL called "From Day One (FDO)", a comprehensive patient-centered program designed to educate and provide non-clinical, psychosocial, emotional support to expectant mothers from the 1st trimester of pregnancy through their child's first year of life. The intervention has been modified by the POPPY Study Team and Community Advisory Board.
|
DHI Plus CHW
n=11 Participants
This group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions.
|
Usual Care
n=10 Participants
This group will receive routine prenatal care services.
|
|---|---|---|---|---|
|
Maternal Postpartum Readmission
Readmission
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Maternal Postpartum Readmission
No Readmission
|
9 Participants
|
10 Participants
|
10 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Birth to 6 weeks of lifeAnswer to the question " How is your baby doing?"
Outcome measures
| Measure |
Digital Health Intervention (DHI)
n=9 Participants
This group will receive routine prenatal care services. Additionally, those randomized to this arm will receive a DHI intervention. A modified DHI will be utilized that was developed by Memora Health in conjunction with EQUATE partners at UPenn and feedback from the POPPY Study Team and Community Advisory Board. All content is designed for 7th grade Flesch-Kincaid level or lower.
|
Community Health Worker (CHW)
n=10 Participants
Individuals randomized to this group will receive routine prenatal care services. Additionally, they will receive a CHW intervention. The CHW intervention will be adapted from an ongoing CHW program in Jefferson County, AL called "From Day One (FDO)", a comprehensive patient-centered program designed to educate and provide non-clinical, psychosocial, emotional support to expectant mothers from the 1st trimester of pregnancy through their child's first year of life. The intervention has been modified by the POPPY Study Team and Community Advisory Board.
|
DHI Plus CHW
n=11 Participants
This group will receive routine prenatal care services. Additionally, this group will receive both DHI and CHW interventions.
|
Usual Care
n=10 Participants
This group will receive routine prenatal care services.
|
|---|---|---|---|---|
|
Neonatal Hospital Readmission
Baby Died
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Neonatal Hospital Readmission
Healthy
|
8 Participants
|
8 Participants
|
7 Participants
|
7 Participants
|
|
Neonatal Hospital Readmission
Some Illness (Hospitalization, Clinic, or ER)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Neonatal Hospital Readmission
Missing
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Digital Health Intervention (DHI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Community Health Worker (CHW)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DHI Plus CHW
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Rachel Sinkey
University of Alabama at Birmingham
Phone: (205) 934-5612
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place