Obesity Clinical Trial
Official title:
The Influence of Evidence-based Educational Materials and Local Resources in Improving Physical Activity-related Outcomes Among Pregnant Women
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.
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).
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