INcreasing Steps in PREgnancy Study
Condition: Pregnancy Related; Exercise; Sedentary Behavior; Behavior and Behavior Mechanisms
Study type: Interventional

Summary: 
      This pilot study will test the feasibility, acceptability, and efficacy of a
      remotely-delivered intervention for increasing daily physical activity levels and reducing
      sedentary behavior during pregnancy among women who are insufficiently active (i.e. reporting
      <150 minutes/week of moderate intensity activity and/or <7,000 steps/day). It is hypothesized
      that women will increase daily steps and decrease total sedentary time across the second
      trimester of pregnancy.
    

Detailed description: 
      Physical activity during pregnancy is safe for the mother and baby and has many health
      benefits; however, less than 25% of pregnant women meet the recommended physical activity
      guidelines. Data from the investigative team also indicates that high sedentary behavior
      across pregnancy trimesters is associated with an increased risk of hypertensive disorders of
      pregnancy and other adverse pregnancy outcomes, independent of physical activity level. There
      is a clear need to encourage physical activity participation while concurrently promoting a
      reduction in sedentary time during pregnancy.

      This pilot study will test the feasibility, acceptability, and efficacy of a
      remotely-delivered intervention for increasing daily physical activity levels and reducing
      sedentary behavior during pregnancy among women who are insufficiently active (i.e. reporting
      <150 minutes/week of moderate intensity activity and/or <7,000 steps/day). We hypothesized
      that participants would increase daily steps and decrease total sedentary time over the
      course of the intensive intervention phase (second trimester, ~14 weeks). Further, we
      hypothesized that participants would maintain or have minimal changes in daily steps and
      total sedentary time from the end of the intensive intervention phase through the follow-up
      phase (third trimester, ~14 weeks).

      Intervention Summary: Participants have 12 contacts with a health coach using a telehealth
      platform to provide ongoing support and discuss physical activity and sedentary behavior
      goals based on real-time data obtained from a Fitbit monitor. Intervention contacts will be
      weekly for the first month, bi-monthly in months 2-4, and monthly until delivery.
      Participants will also receive one text message between each intervention contact to
      reinforce content discussed in coaching sessions. Physical activity and sedentary time will
      be assessed objectively using an activPAL device for 7-days at baseline and at the end of the
      intensive intervention phase (second trimester, ~14 weeks).

      Specific Aims:

      Aim 1: To test the feasibility of a remotely-delivered intervention designed to increase
      physical activity levels and reduce sedentary behavior during pregnancy. Feasibility will be
      defined by: (1) recruitment and enrollment of at least 50% of eligible women who completed
      the screening form, (2) retention of 85% or more participants from baseline through delivery,
      (3) adherence if participants attended 75% or more of the health coaching sessions on average
      and wore and synced their Fitbit device on at least 75% of days from baseline through the end
      of the intervention.

      Aim 2: To test the acceptability of a remotely-delivered intervention designed to increase
      physical activity levels and reduce sedentary behavior during pregnancy. Acceptability will
      be defined as at least 75% of the participants indicating they were satisfied or very
      satisfied with the program overall.

      Aim 3: To test the preliminary efficacy of a remotely-delivered intervention designed to
      increase physical activity levels and reduce sedentary behavior during pregnancy. Efficacy
      will be determined using paired t-tests to assess activPAL-measured changes in physical
      activity (steps/day, stepping minutes/day, standing minutes/day) and sedentary behavior
      (sedentary minutes/day, total and in bouts of 30 and 60 minutes) from baseline through the
      end of the second trimester (intensive intervention phase). The intervention specifically
      aims to increase physical activity levels and reduce sedentary behavior from enrollment
      through the end of the second trimester of pregnancy (intensive intervention phase), and then
      will encourage participants to maintain activity levels based on their comfort level through
      the third trimester (follow-up phase).
    

Intervention name(s): Remotely-delivered health coaching intervention
Intervention type(s): Behavioral
Intervention description(s): Single-arm remotely-delivered health coaching intervention to increase physical activity and reduce sedentary behavior during pregnancy, consisting of 12 health coaching sessions.
Intervention model: Single Group Assignment
Intervention model description: Single-arm remotely-delivered health coaching pilot intervention study
Masking: None (Open Label)
Primary purpose: Prevention