Clinical trial NCT04480931: Pilot Testing a Mobile App to Designed to Increase Physical Activity Among Pregnant and Postpartum Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Postpartum
Keywords: exercise
physical activity
mobile health
intervention
Lead sponsor: Western Kentucky University
Sponsor class: OTHER
Collaborators: name: University of Kentucky
First posted: 2020-07-22
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pregnant women will be recruited \~20 weeks pregnant and after baseline assessments, randomized into the control or intervention group. The intervention group will utilize the mhealth intervention, while the control group will receive basic educational materials only.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: After contact is established and eligibility confirmed, Participants (N=40) will be enrolled and baseline surveys will be conducted to collect information about lifestyle, mental health, and anxiety levels. Patient data for those participants who have agreed to be in the study and have specifically agreed on the consent form to allow the study team to pull data from their prenatal charts. The data being pulled from charts will include patient weights, vital signs, blood pressures, current complications, blood analytes, and glucose tolerance test results from each prenatal visit. After the baby is born, delivery reports will also be obtained in order to collect information on the delivery outcomes (gender, mode of delivery, complications, time in labor) and baby's anthropometric data (birthweight, birth length, head circumference).

Compensation will be in the form of Amazon gift cards (delivered electronically). There will be 4 time points where they take the online assessments. At each time point, they will also be mailed an Actigraph accelerometer to wear for one week. These will be sanitized and mailed or dropped off to avoid any contamination from the study team to participants. When the week is over, the study team will check in with participants and discuss a plan for pick up. They can leave outside for a study team member to pick up (contactless ) or they can mail it back (with provided return envelope).

Each participant will still receive a total of $160. They be recruited and consented online around 18-20 weeks. Assessments will occur at 4 timepoints: baseline assessments at 23-25 weeks gestation ($40), phone check at 30 weeks, second assessment/set of surveys at 35-37 weeks ($40), delivery outcomes obtained, 6 week postpartum surveys ($40), and 12 week postpartum surveys ($40).

Statistical Analyses:

Sample Size Determination: Sample size for this pilot study was determined based on previously performed physical activity interventions among pregnant women. The effect size (0.91) for the main outcome of physical activity was determined from looking at post-intervention physical activity data from Asci et al.83. With this effect size, it was determined using SAS software with a type I error rate of 0.05 that a sample size of 20 per group could detect this difference with 80% power, thus our sample size of 15 per group is justified for a pilot project.

Data Analyses:

Aim 1: To estimate the success and feasibility of recruitment methods, the number of people who will hear about the study via various methods (e.g. health care providers, health fairs, word-of-mouth) will be estimated. Then, the number of women who completed initial screening, the number of women who meet the eligibility criteria, the number of women who complete each of the assessments, the number of women randomized, and the number of women who adhere to the intervention will be determined. The exit interview data will be analyzed via standard content analyses for qualitative studies as previously described84 (and recently performed by our group). Aim 2: Although the investigators may not detect all between group differences because the investigators are proposing a pilot project, appropriate statistical tests will be performed in order to examine trends, and thus, promise for effect in the larger future trial. Normality of the distribution for each variable will be tested using Kolmogorov-Smirnov tests, and non-normally distributed data will be transformed as needed. The baseline characteristics of the two groups will be compared using t-tests or Chi square tests. The potential effect of the intervention on study outcomes will be explored using repeated measures ANOVAs (group x time). Specifically, physical activity data between groups will be compared from pre-post intervention. All data will be entered in Redcap data management system. Analyses will be conducted using SAS or other statistical software.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment feasibility during pregnancy
timeFrame: Pregnancy (23-25 weeks gestation)
measure: Protocol retention
timeFrame: 12 weeks postpartum
measure: Adherence to intervention
timeFrame: Pregnancy (35-37 weeks pregnant)
measure: Adherence to intervention
timeFrame: Postpartum (12 weeks after delivery)
measure: Acceptability of Intervention
timeFrame: Postpartum (12 weeks after delivery)
measure: Physical activity levels
timeFrame: Pregnancy (23-25 weeks gestation)
measure: Physical activity levels
timeFrame: Pregnancy (35-37 weeks gestation)
measure: Physical activity levels
timeFrame: Postpartum (12 weeks)
measure: Physical activity levels
timeFrame: Postpartum (6 weeks)
Secondary outcomes:
measure: Maternal weight status
timeFrame: Pregnancy (23-25 weeks gestation)
measure: Maternal weight status
timeFrame: Pregnancy (35-37 weeks gestation)
measure: Maternal weight status
timeFrame: Postpartum (12 weeks post-delivery)
measure: Maternal blood pressure
timeFrame: Pregnancy (23-25 weeks gestation)
measure: Maternal blood pressure
timeFrame: Pregnancy (35-37 weeks gestation)
measure: Maternal blood pressure
timeFrame: Postpartum (6 weeks post-delivery)
measure: Maternal insulin resistance
timeFrame: Pregnancy (24-29 weeks gestation)
measure: Maternal endothelial dysfunction
timeFrame: Pregnancy (35-37 weeks gestation)
measure: Maternal postpartum depression
timeFrame: Postpartum (12 weeks post-delivery)
measure: Maternal mood
timeFrame: Pregnancy (23-25 weeks gestation)
measure: Maternal mood
timeFrame: Pregnancy (35-37 weeks gestation)
measure: Maternal mood
timeFrame: Postpartum (6 weeks post-delivery)
measure: Maternal mood
timeFrame: Postpartum (12 weeks post-delivery)
measure: Mental Health
timeFrame: Pregnancy (23-25 weeks gestation)
measure: Mental Health
timeFrame: Pregnancy (35-37 weeks gestation)
measure: Mental Health
timeFrame: Postpartum (6 weeks post-delivery)
measure: Mental Health
timeFrame: Postpartum (12 weeks post-delivery)
measure: Infant birthweight
timeFrame: At time of delivery
Other outcomes:
Locations:
city: Bowling Green
country: United States
facility: Western Kentucky University
state: Kentucky
Study officials:
References: