Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change is being assessed for an increase or decrease in self-reported healthy lifestyle beliefs |
Healthy Lifestyle Beliefs Scale survey will be administered at each of the in-person meetings. This scale taps beliefs about various facets of maintaining a healthy lifestyle. This 16-item is scored on a five point Likert-type scale that ranging from 1 strongly disagree to 5 strongly agree. The higher the score the higher the beliefs of maintaining a healthy lifestyle. |
Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit |
|
Primary |
Change is being assessed for an increase or decrease in self-reported Anxiety level |
The Generalized Anxiety Scale (GAD-7) is a 7-item survey which measures anxiety will be administered at each of the in-person meetings. The GAD-7 is a 7-item, 4-point Likert-type scale ranging from (0) Not at all to (3). Scores range from 0 to 21, with higher scores indicating greater functional impairment related to the patient's experience of anxiety. A score greater than or equal to 10 indicates moderate and higher anxiety and will be used in this study, |
Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit |
|
Primary |
Change is being assessed for an increase or decrease in self-reported stress |
The Perceived Stress Scale (PSS) is a scale measuring stress will be administered at each of the in-person meetings. This scale is a standardized measure of global stress designed to elicit the degree to which respondents find their lives unpredictable, uncontrollable, and overloading (three central components of stress). A score of 20 or greater is the high stress cut-off and will be used in this study. |
Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit |
|
Primary |
Change is being assessed for an Increase or decrease in self-reported healthy lifestyle behaviors |
The Healthy Lifestyle Behaviors Scale survey will be administered at each of the in-person meetings. Participants respond to each of the 15 items (e.g., I exercised regularly; I talked about my worries) on a 5-point Likert-type scale that ranges from 1 strongly disagree to 5 strongly agree. The higher the score the higher the healthy lifestyle behaviors are practiced. |
Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit |
|
Primary |
Change is being assessed for an increase or decrease in self-reported depressive symptoms |
The Edinburgh Postnatal Depression Scale (EPDS) is a scale measuring depressive symptoms will be administered at each of the in-person meetings. The Edinburgh Postnatal Depression Scale is a 10 item self-report perinatal depression questionnaire. The scale asks participants to describe how they have felt in the previous week. Unlike other depression screening tools, the EPDS excludes questions regarding somatic symptoms of pregnancy and has been found to be equivalent to a structured interview in determining prevalence of depression. Scores range from 0-30 with higher scores signifying higher severity of depressive symptoms. A cut-off score of 10 on the EPDS will be used in this study to indicate moderate depressive symptoms. |
Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit |
|
Secondary |
birth weight |
record of birth weight as recorded in patient's medical file |
T2= 6-8 week postpartum visit |
|
Secondary |
Mode of Delivery: C-section, forceps/vacuum, vaginal |
record of mode of delivery as recorded in patient's medical file |
T2= 6-8 week postpartum visit |
|
Secondary |
Breastfeeding initiation time |
DPI Form: survey administered at meeting 3 and meeting 4 |
T2= 6-8 week postpartum visit and T3 = at 6 month well baby visit |
|
Secondary |
breastfeeding duration |
DPI Form: survey administered at meeting 3 and meeting 4 |
T2= 6-8 week postpartum visit and T3 = at 6 month well baby visit |
|
Secondary |
Mode of Delivery |
(C/S, Vaginal, Forceps/Vacuum) |
T2= 6-8 week postpartum visit |
|
Secondary |
COPE-P Acceptability |
Index (COPE-P group): Survey administered at meeting 2 and meeting 3 |
T1 = 31 gestational weeks, T2= 6-8 week postpartum visit |
|
Secondary |
Nutritional intake |
24 Hour Nutrition Log/Food Processor: survey will be administered at each of the in-person meetings |
Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit |
|
Secondary |
Level of Exercise |
Fitbit Flex 2 Accelerometer report data: data from Fitbit Flex 2 report will be collected at each of the in-person meetings |
T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit |
|
Secondary |
Gestational age at birth |
Gestational age at birth will be collected as reported on patient's medical chart |
T2= 6-8 week postpartum visit |
|
Secondary |
Participant weight |
weight in pounds will be collected and reported at each of the in person meetings |
Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit |
|
Secondary |
Participant Body Mass Index (BMI) |
derived calculation from weight and height values reported at each of the in person meetings |
Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit |
|
Secondary |
Participant height |
height in feet and inches will be recorded at each of the in person meetings |
Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit |
|
Secondary |
Group Prenatal Care Acceptability |
Survey addressing participant responses to prenatal care in a group setting |
T1=31 gestational weeks |
|
Secondary |
Program Evaluation |
Separate forms for intervention and attention control that address qualitative data regarding participant experience in study program as well as delivery method, virtually or in-person |
T1=31 gestational weeks; T3=6 month well-baby visit |
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