PICO/PECO Criteria

BACKGROUND AND RATIONALE

Background

Gestational Diabetes (GD) is the most common medical condition in pregnancy (Artal, 2003a; Dye,

Knox, Artal, Aubry, & Wojtowycx, 2007). GD is defined as an “abnormal carbohydrate intolerance of variable severity that is first manifested during pregnancy and ends with childbirth” (Artal, 2003b; Catalano, Kirwan, Hagel-de Mouzon, & King, 2003). Even though GD begins and ends with pregnancy, GD may be a risk factor for diabetes mellitus after this pregnancy. GD is associated with the maternal development of type 2 diabetes mellitus (T2DM) later in life (Kim, Newton, & Knopp, 2002; Verma et al., 2002). Up to 40% of women with GD develop T2DM within four to fifteen years after experiencing GD (Albaeda et al., 2013; Brody, Harris, & Lohr, 2003).

GD increases perinatal morbidity (Artal, 2003b). Pregnant women with GD have increased rates of hypertension and cesarean birth. Infants of women with GD experience increased birth injuries, metabolic deviations, and are more likely to become obese and develop T2DM during adolescence (National Diabetes Data Group, 2015). Little is known about the effects of long-hours walking during pregnancy with diagnosed GD as compared to those pregnant women with low physical activities (PA).

Rationale

Physical exercise such as brisk walking is a well-known adjunctive or alternative therapy for the

control of elevated blood glucose for nonpregnant individuals with Type 2 Diabetes Mellitus

 

(T2DM) (Nelson, Reiber, & Boyko, 2002; Reusch, 2002).  Pregnant women sometimes do not participate in physical exercise because of fear of risk to the fetus (Artal, 2003b). As it has become apparent that risk to the fetus is minimal (Kennelly, McCaffrey, McLoughlin, Lyons, & McKenna, 2002), researchers have begun to investigate the possible benefits of physical exercise for maternal glycemic control during pregnancy. Recent studies suggest that physical exercise for women with GD improves glycemic control thereby reducing maternal and fetal morbidity

(Artal, 2003b).

Literature Review

The effects of maternal physical exercise are probably through enhanced glucose uptake by skeletal muscle. Physical exercise promotes the glucose uptake in skeletal muscle, thus reducing hyperglycemia (Artal, 2003b; Booth, Gordon, Carlson, & Hamilton, 2000). Improving maternal

glycemic control reduces the risk of fetal hyperglycemia during pregnancy (Artal, 2003b; Bessinger & McMurray, 2003; Jovanovic, 2000). Improved glucose levels are a reflection of reduced insulin resistance. Thus maternal physical exercise behaviour has the potential to reduce the complications associated with insulin resistance.

Physical exercise counteracts the insulin resistance of T2DM and increases glucose transport into the muscle cells (Goodpaster, He, Watkins, & Kelley, 2001). Pregnant women might also benefit from long walks as a means to control blood glucose either in normal or Gestational Diabetes (GD) pregnancies (Artal, 2003; Bessinger & McMurray, 2003). The focus on this research is the comparison of the effects of two-hours walking of GD pregnant women to those pregnant women with low physical activities as to improved GD treatment and quality of life.

Research Question

Does two hours walking of gestational diabetes (GD) women during pregnancy improve the treatment of GD and quality of life compared to those with low physical activities (PA)?

Objectives and Hypothesis

The primary objective of this research is to compare the effect of two-hours walking of GD women during pregnancy to those with low physical activities (PA).

Hypothesis: Women who perform two-hours walking improve treatment of GD than those women with low PA as to.

  1. The interval between the initial clinic visit and need for insulin.

Hypothesis: Pregnant women participating in two-hours walking will have a longer interval between the onset of therapy and initiation of insulin treatment than women with low PA.

  1. The amount of insulin required.

Hypothesis: The amount of insulin required will be lower in women performing two-hours walking than those women with low PA.

The secondary objective is to compare the effect of two-hours walking of Gestational Diabetic (GD) women during pregnancy to those with low physical activities (PA) on the quality of life. Thus, qualitative analysis will help clarify the relationships between two-hours walking to the treatment of GD, and the quality of life.

Plain English Summary

Currently there are studies published for the benefits of physical exercise to pregnant women with GD; however, evidence-based studies for the extent two-hours walking is beneficial for the improvement of GD treatment is lacking. Hence, this study is designed to compare the quality of life among GD pregnant women who do two-hours walking a day to those with low physical activities. Specifically, the study would like to find out the effect of long walking and low physical activities through a randomized controlled trial consisting of two groups, a group of GD women who performs two-hours walking a day for six weeks then compare their health results in, particular, the improved treatment of GD with a control group who does low physical activities only. Moreover, to find out pregnant GD women perceptions of the quality of life brought by the two-hours walking impact on their health, this study will assess the use and attitude of pregnant GD women towards physical exercise through a qualitative and a quantitative questionnaire and a semi-structured interview.

research PLAN

Methods

This proposed study will utilize a mixed-methods design to answer this study’s main question, “Does two hours walking of gestational diabetes (GD) women during pregnancy improve the treatment of GD and quality of life compared to those with low physical activities (PA)?”

To build on the strengths of both quantitative and qualitative approaches, a randomized controlled trial design will be chosen for this study. An emphasis is placed on the quantitative method, while the qualitative section will serve to clarify and expand upon the quantitative results (Creswell 2011). The quantitative methods will be used to develop instruments, measure variables, and statistically assess the impact of two-hours walking of GD women on the treatment of GD during pregnancy to provide valid, objective, and generalizable data. The second, qualitative phase of the study will utilize a semi-structured interview to assess GD women’s’ personal experiences of the quality of life perceived due to high or low physical activities.

Sample Size, power calculations and sample inclusion / exclusion criteria

Approximately 50% of pregnant women with GD in the ____ area are prescribed insulin treatment. To calculate the sample size, it is estimated that the incidence of insulin use would need to be reduced to 25% to be considered statistically significant. For 0.8 power, alpha = 0.05 the sample size has been calculated at N=32 subjects equally randomized into each of the two groups.

So the subjects will be 32 otherwise healthy, non-smoking pregnant women with a documented diagnosis of GD between week 26 and 32 of gestation. Clearance to enter the study will be provided by the physician monitoring each subject’s pregnancy. All subjects will be provided with written informed consent before entering the study.

Subjects will be recruited from the Diabetic Outpatient Clinics at the _____Hospital.

The Inclusion criteria for the study will include the maternal age between 20-40 years, gestational age between 26-32 weeks, body mass index below 40, and non-smokers who are not involved in a regular exercise program. The study design, information form, and informed consent form will be approved by the University of ____ Ethics Board. Site approval will be obtained from both the _____ Hospital.

Subjects will be approached upon their first visit to the Diabetes Outpatient Clinic. Interested individuals will be given an information form and will be asked to complete a medical screening form as well as the informed consent form. Subjects will be randomized using a random numbers table. The allocation will be concealed in sequentially numbered opaque envelopes. Each new subject entering the study will receive the next envelope in sequence.

Inclusion Criteria

  • Age 20-40 years
  • Non-smoker
  • Physician diagnosis of GDM
  • Between 26 and 32 weeks gestation
  • Pre-pregnant body mass index (BMI) below 40
  • No current regular exercise regimen

Exclusion Criteria

  • Clinically significant valvular or ischemic heart disease
  • Type I diabetes mellitus, peripheral vascular disease, thyroid disease or uncontrolled hypertension, other serious system disorder
  • An incompetent cervix
  • A history of two or more spontaneous abortions
  • Bleeding or placenta previa ruptured membranes, premature labour
  • Toxemia or pre-eclampsia (current pregnancy)
  • Evidence of fetal growth retardation (current pregnancy)
  • Multiple pregnancies (i.e. twins)

The ability to determine the effects of two-hours walking of GD women on the various outcomes will be limited by subjects’ compliance to the diet advice as well as the walking program.

Data Collection

During the Study Protocol

Glucose monitoring will include a daily fasting and 1- or 2-hour postprandial measurements with portable glucometers. Nurse educators will be provided instruction on home glucose monitoring. Instruction in cleaning, calibration, and troubleshooting of the monitors was included in the subjects’ education. Blood glucose values will be recorded in a logbook so that mean blood glucose values could be determined. A random glucose measurement will be taken in a reference laboratory at least once during treatment to ensure the accuracy of the meter.

Insulin therapy will be initiated if at any time during therapy two of the following three values were exceeded:

Mean fasting > 5.3 m mohl- or Mean 1 -hour postprandial > 7.8 m rnol ‘L- or 2-hour postprandial > 6.7 mm nM,-

Subjects will be encouraged to continue the walking exercise protocol for the measurement of the secondary endpoints.

Goal of treatment

The goals for treatment will be as follows:

< 5.3 mmol’L- fasting glucose

< 7.8 mmol»L-1 hour postprandial glucose

< 6.7 mmo M / 2 hour postprandial glucose

>3.5 mmo M / = minimum glucose concentration

Subjects will be instructed to stop the walking exercise and consult the physician if any of the following warning signs or symptoms will occur:

  •  Pain
  • Bleeding
  • Dizziness
  • Shortness of breath
  • Palpitations
  • Faintness
  •  Tachycardia
  • Back pain
  • Pubic pain
  • Difficulty walking

Data Analysis Strategies

The primary endpoint of this study is the requirement for insulin in GD. The number of pregnant women requiring administration of insulin will be compared between the two groups. As the intent is to treat trial, subjects will be analysed according to the groups to which they will be randomized. Secondary endpoints will include the length of time that insulin treatment will be delayed and the amount of insulin that would be administered.

A sub-group analysis will be performed to determine the requirement for insulin between the treatment groups only in women with a body mass index above 25 kg/m2.

A chi-square test will be used to analyse the primary endpoint of the requirement for insulin. The independent samples t-test will be used to analyse the secondary endpoints.

The power to detect a significant difference will be calculated using the Pearson-Hartley chart. Variables that are not normally distributed will be analysed with the Mann- Whitney U-test.

Ethical considerations and Concerns

This study is to be approved by the Human Subjects Committee of the University of _____ prior to commencement of the study (see Appendix A). Permission will then be obtained to recruit subjects from an obstetrician’s clinic in. This clinic serves several obstetricians who oversee the majority of yearly ____ births. The clinic will be the primary investigator with an office out of which to work and in which to store blank and completed questionnaires.

GD pregnant women will be invited and provided with information describing the study and notified that they are under no obligation to participate.

GD pregnant women who indicated that they are interested in participating will be given a clipboard and a pen. The clipboard contained the Letter of Invitation and Letter of Informed Consent (see Appendices B and C). Each interested GD pregnant woman will complete an informed consent document prior to her participation. They participants will be assured that they will be assigned a coded numbers, and that individuals will not be identified by name but by numbers.  A potential risk of participation is a breach of privacy by study personnel. In order to safeguard confidentiality, all data will be treated in strict confidence and will be locked in a filing cabinet in the clinic.

Finally, the investigator will always be available at the clinic to answer any questions.

Potential difficulties and Risks

Because no existing research is yet available to answer the research question, “Does two hours walking of gestational diabetes (GD) women during pregnancy improve the treatment of GD and quality of life compared to those with low physical activities (PA)”, a new RCT should be done.

For the quantitative part of this study, low response rate is a potential risk since the participants will be asked to return their completed questionnaires to the clinic. Thus, in an attempt to improve the response rate, several procedures will be conducted (Ransdell, 2006). First, the cover letters were printed on department letterhead, and they were personalized with a hand written note requesting the women’s participation. Second, the questionnaire jackets were printed on bright colored paper (red., blue and yellow) to make the survey more attractive. Third, for those participants not returning the questionnaire, a post-card reminder will be emailed out to participants one week after their second trimester mailing. If the participant did not return the questionnaire within the following week, another second trimester packet will be sent. If the participant still will not return her second trimester questionnaire, her data were coded “did not return,” and she will then be eliminated from the third trimester emailing.

The qualitative semi-structured interview questions on the other hand, may run the risk of reliability and internal validity. Hence, experts from a specific area of specialization—diabetic nutritionists or dieticians from a national certifying organization will critically evaluate the questions.

PPI/E Involvement

GD pregnant women involvement/engagement are applicable to this research proposal. Finding and selectin GD pregnant women involvement for a study can be a challenge. The researcher would have preferred random sampling as preferred for many research strategies, but is very difficult in reality. Because childbearing years are restricted by nature, selecting the population of GD pregnant women to participate was somewhat self-constricting.

Parity was another consideration in selection of GD pregnant women volunteers. Efforts will be made to find the involvement of both parous and non-parous volunteers to ensure that specific feedback concerning the pregnancy experience could be obtained. Women of differing parity involvement is needed to provide a diverse range of experiences with the pregnant condition.

Another involvement feature that will be considered is the choice of sample size. It is necessary for the decision of sample size to take into account various pragmatic factors including population availability, time restrictions, and budget constraints. In consideration of these factors, a sample of 30 GD pregnant women subjects will be chosen as minimum numbers of volunteers to be used in this study (McMillan & Schmacher, 2001, p. 177).

Anticipated Impact

The importance of exercise to pregnant women is evident. Hence, this study may provide valuable insight as to how much walking may improve the treatment and quality of life of GD women during pregnancy.  Despite women’s concerns about the impact of exercising during their pregnancy, it contributes positively to women’s health (USDHHS). In addition, the ACOG recommends that healthy pregnant women exercise moderately for at least 15 min per day, 3 to 5 days per week. Thus, to promote physical activity during pregnancy, it is necessary to examine the impact of longer duration of walking during this time. Moreover, it is important to study the impact of exercising and pregnancy because the literature is scant, and it is limited by several factors, including;

  • Small sample sizes (Berg, 2009).
  • A lack of theoretical research explaining the determinants of exercising during

pregnancy (Walker, Cooney, & Riggs, 2000).

  • Methodological concerns with using nonstandardized exercise measures (Eisen,

Rield, & Larason, 2001).

Proposed Methods of Dissemination

Walking as an exercise session every other day may prove to be more acceptable to many GD pregnant women than daily insulin injections. In an effort to adhere to the theory guidelines developed by Ajzen and Fishbein (1980) and to achieve the general objective of this proposal, two groups of women studies will be conducted.

Diet Alone Without Walking Exercise

All subjects will be managed with a standard diet that consisted of 40% carbohydrate, 20% protein, and 40% fat to be calculated at 24 to 30 kcal/kg/day divided into three meals and three snacks. A registered dietician will administer each subject’s diet plan. Meal plans will be individualized to account for the ethnic background and food preferences of each subject. Subjects will be monitored weekly to ensure appropriate weight gain.

The women in the diet alone group will be asked not to walk more than an hour a day and to engage in low physical activities only during the remainder of the pregnancy.

Diet Plus Two-hours Walking Exercise

The two-hours walking exercise group will be followed the same standard diet while participating in a two-hours walking exercise program. An experienced instructor will supervise the first three sessions to ensure the safety of participants. Subjects in the walking program group will be instructed to do walking exercise two-hours per day. Subjects will be taught to monitor their heart rate during exercise to ensure that it did not rise above 140 beats per minute. All walking exercise sessions will be recorded in a logbook. Thus, the remainder of this paper will examine the evidence that walking exercise can be used as an alternative treatment to insulin in gestational diabetes.

The researcher proposed dissemination through Obstetrician clinics` and diabetic organizations` websites.

 

Timetable / GANTT chart

ACTION December  2017 January  2018 February

2018

March

2018

1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4  
Proposal Writing                                  
Introduction                                  
Literature reviews                                  
Data Collection                                  
Data Analysis                                  
Research Results                                  
Final Dissertation  Writing                                  

references

Albaeda MD, Cabellero AC, Badell GC, Piquer SA, Ortiz AT, de Leiva, AL, Corcoy RC. Diabetes and abnormal gucose tolerance in women with previous gestational diabetes. Diabetes Care, 2013; 6:1199-1205.

Artal RA. Exercise and pregnancy. Clinical Obstetrics and Gynecology, 2003a; 377-378.

Artal, RA. Exercise: The alternative therapeutic intervention for gestational diabetes. Clinical Obstetrics and Gynecology, 2003b; 479-487.

Bessinger RC, McMurray RG. Substrate utilization and hormonal responses to exercise in pregnancy. Clinical Obstetrics and Gynecology, 2003; 46: 467-478.

Booth FW, Gordon SE, Carlson CJ, Hamilton MT. Waging war on modern chronic diseases: primary prevention through exercise biology. Journal of Applied Physiology, 2000; 88: 774-787.

Brody SC, Harris RK, Lohr KM. Screening for gestational diabetes: A summary of the evidence for the U. S. Preventive Services Task Force. Obstetrics & Gynecology, 2003; 101: 380-392.

Catalano PM, Kirwan JP, Haygel-deMouzon SJ, King JL. Gestational diabetes and insulin resistance: Role in short and long-term implications for mother and fetus. Journal of Nutrition, 2003; 133:1674S-1683S.

Dye TDV, Knox R, Artal RA, Aubry, RH, Wojtowycx, MA. Physical activity, obesity, and diabetes in pregnancy. American Journal of Epidemiology, 2007; 46: 961-965.

Goodpaster BH, He JC, Watkins SP,  Kelley DE. Skeletal muscle lipid content and insulin resistance: evidence for a paradox in endurancetrained athletes. The Journal of Clinical Endocrinology & Metabolism, 2001; 86: 5755-5761.

Jovanovic LB. The role of continuous glucose monitoring in gestational diabetes mellitus. Diabetes Technology & Therapeutics, 2000; 2: S-67-71.

Kennelly MM, Geary MJ, McCaffrey NA, McLoughlin PA, Staine AM, McKenna PG. Exercise-related changes in umbilical and uterine artery waveforms as assessed by Doppler ultrasound scans. American Journal of Obstetrics and Gynecology, 2002; 187: 661-666.

Kim CB, Newton KM, Knopp, RH. Gestational diabetes and the incidence of type 2 diabetes. Diabetes Care, 2002; 25:1862-1868.

National Diabetes Data Group. National Institute of Diabetes and Digestive and Kidney Diseases. Available from: http://diabetes.niddk.nih.gov/dm/pubs/america/citation.htm

Nelson KM, Reiber GC, Boyko EJ. Diet and exercise among adults with type 2 diabetes: Findings from the Third National Health and Nutrition Examination Survey (NHANES III). Diabetes Care, 2002; 25: 1722-1728.

Reusch JEB. Current concepts in insulin resistance, type 2 diabetes mellitus, and the metabolic syndrome. American Journal of Cardiology, 2002; 90:19G-26G.

Verma AG, Boney CM, Tucker RH, Vohr BR. Insulin resistance syndrome in women with prior history of gestational diabetes mellitus. The Journal of Endocrinology & Metabolism, 2002; 87: 3227-3235.

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