Pregnancy Clinical Trial
Official title:
Pilot Testing of a Mobile Health Intervention Designed to Increase Physical Activity and Improve Morbidity and Mortality-related Outcomes Among Pregnant and Postpartum Women in a Rural Setting
NCT number | NCT04480931 |
Other study ID # | 20-257 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 28, 2020 |
Est. completion date | May 1, 2022 |
Verified date | July 2022 |
Source | Western Kentucky University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this pilot project is to test the feasibility and potential efficacy of the evidence-based mHealth app (BumptUp) for improving physical activity and subsequent health outcomes (i.e. obesity, hypertension, insulin resistance) among pregnant and postpartum women in a rural community. In order to accomplish this goal, feasibility of the intervention protocol will be tested by the assessment of recruitment (how many participants eligible per month), retention (% of women who complete the study protocol), adherence to intervention (% of women who utilize the app), and acceptability (survey and one-on-one exit interviews) during pregnancy and postpartum. Potential efficacy will be determined by examining trends in data on physical activity levels (achieving the goal of 150 minutes per week of physical activity (surveys and accelerometry)) between groups. Other secondary outcomes will also be assessed: weight status, body composition, blood pressure, insulin resistance, fitness levels, mental health, and infant anthropometrics. Clinical hypotheses: 1. The mHealth program will be feasible as evidenced by high rates of enrollment, retention, and adherence, moderate-to-high levels of satisfaction, and low participant burden. 2. The mHealth intervention will show promise towards improving physical activity levels and other secondary outcomes in pregnant and postpartum women in a rural community.
Status | Completed |
Enrollment | 38 |
Est. completion date | May 1, 2022 |
Est. primary completion date | December 20, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 44 Years |
Eligibility | Inclusion Criteria: - 1) Age 18-44 - 2) Confirmed singleton viable pregnancy - 3) English-Speaking (the app is currently only available in English) - 4) Physician release to participate in exercise - 5) Ownership of a smart phone - 6) Plans to deliver at The Medical Center in Bowling Green, KY. Exclusion Criteria: - 1) Multiple gestation pregnancy - 2) Inability to provide voluntary informed consent - 3) Any medical condition (pregnancy-related or not) that would preclude exercise. |
Country | Name | City | State |
---|---|---|---|
United States | Western Kentucky University | Bowling Green | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Western Kentucky University | University of Kentucky |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment feasibility during pregnancy | how many participants eligible and successfully recruited per month | Pregnancy (23-25 weeks gestation) | |
Primary | Protocol retention | % of women who complete the study protocol | 12 weeks postpartum | |
Primary | Adherence to intervention | % of women who use the app daily | Pregnancy (35-37 weeks pregnant) | |
Primary | Adherence to intervention | % of women who use the app daily | Postpartum (12 weeks after delivery) | |
Primary | Acceptability of Intervention | measured via exit interviews | Postpartum (12 weeks after delivery) | |
Primary | Physical activity levels | Assess the potential efficacy of the intervention by examining physical activity levels through objective actigraph data | Pregnancy (23-25 weeks gestation) | |
Primary | Physical activity levels | Assess the potential efficacy of the intervention by examining physical activity levels through objective actigraph data | Pregnancy (35-37 weeks gestation) | |
Primary | Physical activity levels | Assess the potential efficacy of the intervention by examining physical activity levels through objective actigraph data | Postpartum (12 weeks) | |
Primary | Physical activity levels | Assess the potential efficacy of the intervention by examining physical activity levels through Exercise Vital Sign Survey | Postpartum (6 weeks) | |
Secondary | Maternal weight status | Body weight (lbs) | Pregnancy (23-25 weeks gestation) | |
Secondary | Maternal weight status | Body weight (lbs) | Pregnancy (35-37 weeks gestation) | |
Secondary | Maternal weight status | Body weight (lbs) | Postpartum (12 weeks post-delivery) | |
Secondary | Maternal blood pressure | Assessed by nurse at clinical visit using standardized clinical equipment | Pregnancy (23-25 weeks gestation) | |
Secondary | Maternal blood pressure | Assessed by nurse at clinical visit using standardized clinical equipment | Pregnancy (35-37 weeks gestation) | |
Secondary | Maternal blood pressure | Assessed by nurse at clinical using standardized clinical equipment | Postpartum (6 weeks post-delivery) | |
Secondary | Maternal insulin resistance | Oral Glucose Tolerance Test Results | Pregnancy (24-29 weeks gestation) | |
Secondary | Maternal endothelial dysfunction | Assessed with a rapid, non-invasive technique that records endothelium-mediated changes in the peripheral arterial tone signal via a pair of finger probes | Pregnancy (35-37 weeks gestation) | |
Secondary | Maternal postpartum depression | Edinburgh postpartum depression survey | Postpartum (12 weeks post-delivery) | |
Secondary | Maternal mood | Profile of Mood Survey | Pregnancy (23-25 weeks gestation) | |
Secondary | Maternal mood | Profile of Mood Survey | Pregnancy (35-37 weeks gestation) | |
Secondary | Maternal mood | Profile of Mood Survey | Postpartum (6 weeks post-delivery) | |
Secondary | Maternal mood | Profile of Mood Survey | Postpartum (12 weeks post-delivery) | |
Secondary | Mental Health | Center for Epidemiological Studies Depression Survey | Pregnancy (23-25 weeks gestation) | |
Secondary | Mental Health | Center for Epidemiological Studies Depression Survey | Pregnancy (35-37 weeks gestation) | |
Secondary | Mental Health | Center for Epidemiological Studies Depression Survey | Postpartum (6 weeks post-delivery) | |
Secondary | Mental Health | Center for Epidemiological Studies Depression Survey | Postpartum (12 weeks post-delivery) | |
Secondary | Infant birthweight | Collected at delivery by trained nursing staff | At time of delivery |
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