Pilot Testing a Mobile App to Designed to Increase Physical Activity Among Pregnant and Postpartum Women
Condition: Pregnancy; Postpartum
Study type: Interventional

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.
    

Intervention name(s): mHealth Intervention Group; Educational Brochure
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Access to the mobile health application with exercise plans and education; An evidence-based educational brochure with general information about the benefits of physical activity during pregnancy
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: exercise; physical activity; mobile health; intervention