Evidence-based Educational Materials and Local Resources for Improving Exercise-related Outcomes During Pregnancy
Condition: Pregnancy Related; Obesity
Study type: Interventional

Summary: 
      Despite the well-established benefits of physical activity, only 23% of pregnant women report
      exercising in accordance with guidelines recommended by the American Congress of
      Obstetricians and Gynecologists. Further, pregnant women report receiving little or no advice
      about physical activity during pregnancy from their health care provider; thus, the
      scientific evidence supporting physical activity during pregnancy does not appear to be
      translating into the clinic and the community. The goal of this project is to determine if
      the distribution of evidence-based educational materials and local resources will increase
      knowledge regarding the benefits of physical activity during pregnancy, patient-provider
      communication about physical activity during pregnancy, and physical activity levels during
      pregnancy.

      Hypothesis A: Pregnant women who receive evidence-based educational materials and local
      resources will have increased knowledge regarding the benefits of physical activity during
      pregnancy.

      Hypothesis B: Pregnant women who receive evidence-based educational materials and local
      resources will have more communication with their health care provider about physical
      activity.

      Hypothesis C: Pregnant women who receive educational information and local resources will
      report increased physical activity levels.

      Hypothesis D: Pregnant women who receive evidence-based educational materials and local
      resources will have improved pregnancy outcomes including lower gestational weight gain,
      lower insulin resistance (as determined by their clinical oral glucose tolerance test), and
      healthier neonatal birthweight.
    

Detailed description: 
      Physical activity during pregnancy has been shown to be safe and effective in improving
      maternal and neonatal short and long-term outcomes. Despite all of the benefits, only 23% of
      all pregnant women report exercising in accordance with guidelines recommended by the
      American Congress of Obstetricians and Gynecologists. Further, pregnant women report
      receiving little or no advice about physical activity during pregnancy from their health care
      provider; thus, the scientific evidence supporting exercise during pregnancy does not appear
      to be translating into the clinic and the community. With maternal obesity becoming a serious
      public health concern, the need for awareness and communication about physical activity
      during pregnancy is more important than ever before. Kentucky-specific data suggests that the
      incidence of obesity at the first prenatal visit has increased from 7% to 24% over the past
      20 years, and local interventions to reduce obesity during pregnancy are limited. Thus,
      physical activity interventions designed to combat obesity and improve maternal and neonatal
      health are warranted, specifically in rural Kentucky where rates of obesity and physical
      inactivity are considerably higher than the national averages. A goal of this project is that
      it will be the start of a sustainable program that will improve the lives of pregnant women
      and their neonates in the community. The proposed program can grow beyond the city of Bowling
      Green, KY, and this model can be adopted across the state of Kentucky. This program will not
      only educate the population about all of the benefits of physical activity during pregnancy
      (which is important as a previous study demonstrated that rural communities have perceptions
      that support myths about exercise during pregnancy), but it will increase physical activity
      levels among pregnant women. The long-term impact of increased maternal physical activity
      levels in the city, state, and nation is substantial as many studies have shown that physical
      activity during pregnancy has a long-term impact of maternal and neonatal health outcomes.

      Because Kentucky is one of the most obese states in America, it is important local
      interventions are designed to reduce obesity in future generations in order to stop the
      vicious cycle of obesity. If the program succeeds and grows, it has the potential to improve
      the overall health of the city of Bowling Green (and beyond) for years to come. Although
      obesity is a multifaceted issue, and much larger steps need to be taken at the national level
      to combat it, programs such as this are a small step in the right direction. Intervening as
      early as possible (neonatal level) is an important opportunity to improve health in future
      generations. Previous studies have demonstrated that antenatal lifestyle advice improves
      maternal physical activity during pregnancy, and that information regarding risks and
      benefits of exercise during pregnancy can be a source of exercise motivation for pregnant
      women. In addition,this study design removes common barriers to participating in physical
      activity during pregnancy by providing a number of medically-supervised exercise options (one
      of which offers childcare, one of which can be done without leaving the home, and many of
      which have safe and comfortable options for pregnant women), all at no cost to the pregnant
      women.

      The goals of Specific Aim 2 are to increase patient awareness about the benefits of physical
      activity during pregnancy, increase patient-provider communication about physical activity
      during pregnancy, and increase physical activity levels during pregnancy in rural Kentucky
      through the use of evidence-based educational materials and local resources.

      The study team hypothesizes that providing pregnant women with evidence-based educational
      materials and a selection of local resources will increase knowledge about the benefits and
      risks of physical activity, increase patient-provider communication about physical activity,
      and increase physical activity levels during pregnancy. If physical activity levels are
      increased, this study may also help to improve maternal and neonatal outcomes. This study may
      help pregnant women gain less weight during pregnancy, and thus, combat maternal obesity in
      the years following pregnancy.In addition, this study may contribute to healthier offspring
      as physical activity during pregnancy has been shown to reduce offspring birth weight and
      body fat percentage into childhood.

      All participants (N=80) will be recruited from Graves Gilbert Obstetrics, a rural healthcare
      clinic, between 8 and 12 weeks gestation. Once consented to participate, all women will take
      baseline surveys between 8 and 12 weeks gestation. Surveys will be taken before or after
      their prenatal appointment at Graves-Gilbert. If this is not feasible for the participant,
      surveys can be taken home and mailed back to the study team upon completion. Baseline surveys
      will assess knowledge, beliefs, and motivation to be physically active during the index
      pregnancy. In addition, all women will be asked to report physical activity levels during
      their pregnancy. In addition to surveys about physical activity during pregnancy, all
      participants will also receive a Xaomi Mi Band, a wrist-worn physical activity monitor that
      calculates steps and kilocalories expended per day for 30 days at a time. If possible,
      participants will be asked to sync the device with their smart phone and text the study team
      information regarding their steps and energy expenditure. If this is not feasible, the study
      team will meet them once a month at their clinic appointment and sync the data directly to a
      portable laptop device. After baseline surveys are complete, each participant will be
      randomized to the physical activity group (PAG) or the standard of care group (SOC). The PAG
      will receive evidence-based educational information as well as a list of local resources for
      pursuing physical activity. Local resources will be provided to the pregnant women in the
      study at no charge, thus, financial constraints will not be a barrier to physical activity
      during pregnancy for women in the present study. SOC will receive no additional information
      beyond standard-of-care brochures and information. At 32-34 weeks gestation, all women will
      be surveyed once again regarding knowledge and beliefs, motivation, and physical activity
      levels during their pregnancy. The Dietary History Questionnaire II will also be administered
      in order to control for dietary differences between groups that could contribute to outcomes
      being assessed. In addition to the baseline surveys, all women will be surveyed about
      patient-provider communication regarding physical activity during their pregnancy. Outcomes
      will be compared between PAG and SOC groups. Prenatal charts will be obtained after infant
      delivery. Additional maternal and neonatal outcomes will be examined to determine the effect
      of the intervention on outcomes (i.e. gestational weight gain, postpartum weight retention,
      oral glucose tolerance test results, neonatal birth weight).

      The evidence-based educational materials are adopted from previous research that demonstrated
      educational materials motivate pregnant women to exercise as well as alter their beliefs
      about physical activity during pregnancy The evidence-based brochure has been designed and
      made culturally appropriate. Surveys were designed using constructs of the Theory of Planned
      Behavior (knowledge and beliefs) and the Protection Motivation Theory and Health Action
      Process Approach (motivation).

      Statistical Procedures Repeated measures ANOVAs will be used to compare scores on the
      Exercise Belief's Questionnaire I (agree/disagree) and physical activity levels (PPAQ, Mi
      Band data) between the two groups before and after the intervention. Motivation outcomes will
      be assessed by identifying recurring themes in relation to the Protection Motivation Theory
      and Health Action Process Approach and comparing responses between groups. Recurrent themes
      will be identified regarding the Exercise Beliefs Questionnaire II, and improvement will be
      based on the number of correct responses for each question before and after the intervention.
      Patient-provider communication frequency and topic will be compared between the groups using
      chi-square tests. All tests will be two-sided with a p-value <0.05 denoting statistical
      significance. All data analyses will be conducted using IBM SPSS Statistics, Version 22
      (Armonk, New York).
    

Intervention name(s): Physical Activity Education and Resources
Intervention type(s): Other
Intervention description(s): The intervention involves receiving evidence-based educational brochures as well as a list of local facilities where the participant can work out at no-cost to them,
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: physical activity; exercise; patient-provider communication