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| ID | Type | Description | Link |
|---|---|---|---|
| 25CDA1449707 | Other Grant/Funding Number | American Heart Association |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this intervention is to help new mothers who had elevated blood pressure during pregnancy become more physically active after birth. The investigators will connect data from FitBits to the electronic health record. Women will then get weekly messages with feedback and goals to help them stay active. The investigators will test if the intervention improves step counts and blood pressure after pregnancy. The investigators will also test if the intervention is feasible and enjoyed by postpartum women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental |
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| Control Group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Portal Messaging | Behavioral | Participants will receive weekly messages via their patient portal including feedback on their step counts and step count goals based on data from their FitBits |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Recruitment | Number of participants enrolled in the intervention | From enrollment to the end of the 24 week intervention |
| Feasibility of Participant Retention | Percent of enrolled participants who continue to participate in the intervention | At study weeks 12 and 24 |
| Feasibility of FitBit+EHR linkage | Percent of intervention days FitBit data are linked to the Electronic Health Record | From enrollment to the end of the 24 week intervention |
| Feasibility of Intervention Messaging | Percent of weekly messages that are read by participants | From enrollment to the end of the 24 week intervention |
| Acceptability of the Intervention | Participants will fill out a survey to assess the extent to which they were satisfied with individual intervention components including FitBit usage, portal messaging, blood pressure and weight assessments, surveys, intervention length and intervention delivery. Each component will be rated on a 5-point Likert Scale in which 1 represents very dissatisfied (lowest score) and 5 represents very satisfied (highest score). | Study week 24 |
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| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | Systolic blood pressure (mmHg) | Study weeks 0, 12 and 24 |
| Diastolic Blood Pressure | Diastolic Blood Pressure (mmHg) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natalie A Cameron, MD, MPH | Contact | 312-503-2137 | natalie.cameron@northwestern.edu |
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Any factual data that is needed for independent verification of research results will be made freely and publicly available in a repository as soon as possible, and no later than the time of an associated publication or 3/31/2028, whichever comes first.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D046110 | Hypertension, Pregnancy-Induced |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| FitBit EHR Linkage | Behavioral | Participants will receive FitBits and link this step count data with the Electronic Health Record (EHR) |
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| Study weeks 0, 12 and 24 |
| Step Counts | Daily Mean Step Count from FitBits | Study weeks 0, 12 and 24 |
| Self Reported Physical Activity | Self-reported Metabolic Equivalent of a Task (MET)*hours per week based on responses to the Pregnancy Physical Activity Questionnaire | Study weeks 0, 12 and 24 |
| Body weight | Body weight (kg) | Study weeks 0, 12 and 24 |
| Height | Height in inches | Baseline |
| Sleep | Mean hours of sleep per night | Study weeks 0, 12 and 24 |
| Diet | Adherence to Mediterranean diet assessed by the Mediterranean Eating Pattern for Americans Tool | Study weeks 0, 12 and 24 |
| Depression | Score on the Edinburgh Postnatal Depression Scale. Minimum Score: 0 (Least Depressed), Maximum Score: 30 (Most Depressed) | Study weeks 0, 12 and 24 |
| Perceived Stress | Score on the Perceived Stress Scale. Minimum Score: 0 (Least Perceived Stress), Maximum Score: 40 (Most Perceived Stress) | Study weeks 0, 12 and 24 |
| Perceived Anxiety | Score on the Generalized Anxiety Disorder - 7 Scale. Minimum Score: 0 (Little Anxiety), Maximum Score: 21 (Severe Anxiety) | Study weeks 0, 12 and 24 |
| Physical Activity Related Knowledge - Minutes Per Week | Participants will be asked a multiple choice question with 5 possible options about how many minutes per week of exercise is recommended by the government. One option will be considered the correct answer. | Study weeks 0, 12 and 24 |
| Blood Pressure Related Knowledge | Participants will be asked to write a response to the following question: Above which blood pressure does the American Heart Association say someone has hypertension? | Study weeks 0, 12 and 24 |
| Health Care Visits | Number and type of healthcare visits attended | From enrollment through the end of the 24 week intervention |
| Sleep | Score on the PROMIS (Patient-Reported Outcomes Measurement Information System) Sleep Disturbance Short Form. Minimum Score: 8 (low levels of sleep disturbance; Maximum Score: 40 (high levels of sleep disturbance) | Study weeks 0, 12 and 24 |
| Physical Activity Counseling | Number of times participant reports receiving physical activity counseling from a healthcare provider | From enrollment through the end of the 24 week intervention |
| FitBit Counseling | Number of times participant reports discussing their FitBit data with a healthcare provider | From enrollment through the end of the 24 week intervention |
| D000091642 | Urogenital Diseases |
| D001519 | Behavior |