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S.2.30 Prenatal physical activity interventions: Is it time to question the ethical implications of having a no treatment control group? A Debate Symposium

Tracks
Room: Hunua #3 Level 1
Friday, June 19, 2020
5:00 PM - 6:15 PM
Hunua #3 Level 1

Details

Purpose:The purpose of this debate will be to consider alternative study methodologies instead of traditional randomized controlled trials (RCT) for researching exercise during pregnancy so that standard-care control groups are offered at minimum, the exercise during pregnancy guidelines. Rationale:Among research methodologies, RCTs are considered the gold standard. Standard RCTs, including an intervention group(s) and control group(s), are ranked as high quality research methodologies to study behavior change interventions, including evaluating exercise during pregnancy. There are many RCTs that have been completed to study the effect of exercise during pregnancy; in fact, the recent 2019 Canadian Guideline for Physical Activity throughout Pregnancy is based on the review of at least 6,000 RCTs. The Canadian guideline, along with other countries including the United Kingdom, United States of America and Australia, recommend exercise during pregnancy. Furthermore, an abundance of literature has been published on the negative effects of inactivity and sedentary behavior during pregnancy. If there is evidence to suggest that exercise during pregnancy improves health outcomes for both mother and growing fetus and there are harmful effects of inactivity, is it time to question the ethical implications of having a no treatment control group that is not given standard exercise recommendations? The problem is further complicated because wait-listed exercise treatment options cannot be implemented during the prenatal period. These issues raise another question—should other methodologies be given priority, such as superiority (non-inferiority) RCTs and or cohort observational studies? Internationally renowned researchers who study both the behavioral and physiological aspects of exercise during pregnancy will be in attendance, and therefore the debate will include the value of RCT-based research from both perspectives. Second, although the debate focuses on pregnancy, the topic can be applied to other population groups and a variety of lifestyle-based interventions. Furthermore, methodologists will have a keen interest in this topic and can support the discussion by providing insight and recommendations for the future of behavioral study designs. Objectives: 1. Understand why RCT-based research that includes a standard care control group may still be required for studying exercise during pregnancy; 2. Understand the rationale for considering alternative study designs including superiority trials and cross-sectional studies, instead of traditional RCT-based research with standard care control groups for studying exercise during pregnancy; 3. Challenge using ‘standard care’ for prenatal based lifestyle interventions and consider giving control groups at minimum, exercise guidelines.


Speaker

Dr. Michelle Mottola
Professor
University Of Western Ontario

In favor argument for using standard Randomized Control Trials

Abstract

Purpose: Randomized controlled trials (RCT) provide a structured research approach to test the health effects of exercise during pregnancy. The purpose of this presentation will be to detail areas of research that lack evidence for the health benefits of exercise during pregnancy and how RCT-based research is required to fill in these gaps. Furthermore, this presentation will discuss the limitations within previous RCTs that should be addressed before moving forward to other methodologies.

Methods: A literature review of international exercise during pregnancy guidelines will be completed to provide a summary of research areas that still require further investigation. Additionally, the quality of RCTs that have been evaluated among guidelines will be summarized and presented. Finally, a list of limitations among previous standard RCTs will be summarized.

Results: A large proportion of the pregnant population has not been included in previous RCTs that include a standard no-treatment control arm, and therefore there are many areas of research that require further investigation before recommending that all women should receive an exercise intervention. Examples include: women with twin or more pregnancies, a body mass index >40.0kg/m2, previous incidence of miscarriages, high blood pressure or diabetes, and a history of eating disorders. Standard non-contact control groups are still required to test the effect of exercise during pregnancy among these population groups to assure standard guidelines are safe and effective. Furthermore, improving the quality (rigor) of these studies also is required before conclusions can be made regarding the effectiveness and efficacy of exercise treatment. Common limitations of previous RCTs include low adherence, a lack of validated and objective measures of physical activity, incorrect use or lack of blinding for evaluating study results and limited follow-up periods. In addition, in order to determine specific mechanistic pathways on the effects of exercise, a non-intervention control group is required.

Conclusion: Before moving away from standard RCT based studies to evaluate exercise during pregnancy, areas of research that require further investigation and previous study limitations need to be addressed. 

Dr. Kristi Adamo
University of Ottawa

Opposing argument for standard Randomized Controlled Trials

Abstract

Purpose: As there is an abundance of research to support the health benefits of exercise during pregnancy for both mother and growing fetus, the opposing presentation will propose providing standard exercise guidelines to control groups within randomized controlled trials (RCT). Furthermore, as there are harmful effects of inactivity and sedentary behavior, this presentation will challenge the ethical implications of having a non-intervention control group and propose alternative study methodologies including superiority trials and cross-sectional designs.

Methods: A literature review of international guidelines will be completed and general summaries will be provided to highlight overall recommendations for exercise during pregnancy. A summary of systematic reviews and meta-analyses will be presented that will provide evidence for the benefits of exercise during pregnancy and potential harms as a result of inactivity. Finally, alternative study designs to the standard RCT will be proposed.

Results: International guidelines for exercise during pregnancy all recommend that pregnant women without any contraindications should engage in exercise throughout all trimesters. A specific example includes the Canadian Guideline document that recommends 150 minutes of moderate exercise, at least 3 times per week, spread throughout the week. Research has shown that exercise during pregnancy has a preventative effect for a number of pregnancy complications including gestational diabetes and hypertension, and can protect the growing fetus from later-life chronic conditions including obesity. Instead of RCT-based studies where a control group is denied potential exercise benefits, future studies should provide at minimum the exercise guidelines and explore alternative methodologies.

Conclusions: Alternative methodologies instead of standard RCTs may allow research related to exercise during pregnancy to advance. By prioritizing alternative study designs to traditional RCTs with no treatment controls, researchers may be able to answer novel questions related to exercise during pregnancy including determining strategies to bolster adherence to exercise. Furthermore, alternative designs will also assure that all women are receiving some form of exercise within a study, and as a result more women will gain the benefits of leading an active lifestyle during pregnancy. Standard care should include at minimum, access to exercise guidelines during pregnancy.


Chair

Harry Prapavessis


Discussant

Harry Prapavessis

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