Proposal: The Effects of Nutritional Counseling on Women with a History of Gestational

Diabetes Mellitus

Kelli Baumgardner
Abbey Crum
Kayla Reddmann
Lauren Yacapraro

FN 4400
Fall 2015

Project Summary
Purpose
The number of cases of Type Two Diabetes Mellitus (DM2) is increasing in the United
States every year. One prominent risk factor that contributes to the incidence of DM2 is
gestational diabetes. Gestational diabetes can be treated with diet and lifestyle
changes; however treatment and care ceases with the birth of the child without regard
for the increased risk of the mother for developing DM2. However, research has shown
that nutritional intervention and counseling has proven successful in the reduction of
DM2 in other populations. The proposed study looks to examine the link between
nutritional intervention and the occurrence of DM2 in women who have experienced
gestational diabetes.
Methods
One hundred women who have a previous medical history of gestational diabetes in the
past three months will be recruited to participate in a randomized control trial in the
Boston area. The women will be divided into intervention and control groups where their
hemoglobin A1C and fasting blood glucose levels will be tested to measure the
effectiveness of nutritional intervention over a five year period.
Results
It is expected that women in the group receiving diabetic diet counseling with a dietitian
will experience lower hemoglobin A1C and fasting blood glucose levels after a five year
period in comparison to the group receiving MyPlate information. Based on the results
of this study, health initiatives and further research could be implemented and
conducted to better DM2 outcomes in women with a previous medical history of
gestational diabetes.
Research Question
Does diabetic lifestyle prevention support after pregnancies in women with a previous
medical history of gestational diabetes lower their risk of developing DM2 in the future?
Hypothesis
It is hypothesized that implementation of diabetic prevention counseling after pregnancy
in women with a previous medical history of gestational diabetes will lower their risk of
developing DM2.
Introduction
It is commonly known that there is an existing link between obesity and DM2. However,
many fail to recognize the correlation between the incidence of gestational diabetes and
the development of DM2. Within five years of having gestational diabetes,
approximately 50% of women will develop DM2 according to previously studied
populations1. This further recognizes the need for diabetic prevention interventions in

populations that have a previous medical history of gestational diabetes. Intensive diet
and lifestyle intervention have been shown to be successful in the decreased incidence
of DM2 in the general population. Currently, there is a cessation of diabetes care after
the birth of a child in the gestational diabetes population. However, this population is at
a very high risk of developing DM2 and should receive further nutritional counseling
following pregnancy to decrease the prevalence of this disease.
Rationale and Significance
A prominent link has been established between the incidence of GDM and increased
likelihood of subsequently developing DM2 or, rarely, type one diabetes mellitus 1.
However, limited research has been conducted to investigate the relationship between
postpartum nutritional counseling and the incidence of DM2 or GDM in a subsequent
pregnancy1,2. Presently, the only research that has been conducted was focused in
obese populations2. The current study proposes to evaluate the relationship between
nutritional counseling and the development of type II diabetes mellitus (DM) following
the incidence of GDM.
The most prevalent risk factor of DM developing subsequently to GDM is impaired
glucose tolerance3. A link has been identified between nutritional counseling and
glycemic control.4 This study also reports that patients who received nutritional
counseling were more motivated to improve lifestyle choices over those who did not 4.
With this information in mind it is hypothesized that increased counseling in the GDM
population will decrease the risk of impaired glucose tolerance, and the development of
DM. It is also suggested that dietary and lifestyle modifications be made such as
maintaining a healthy BMI and appropriate energy intake in order to delay or prevent the
prevalence of DM in women with a history of GDM1.
If the hypothesis is confirmed with this study, dietitians could be integrated into the
primary healthcare team that comes into direct contact with pregnant women which
could further decrease the prevalence of GDM in pregnancies. In addition, providing
nutritional education to mothers affected by GDM could further educate their families on
healthy lifestyle choices. Long term applications could include policy changes to include
nutrition education in both pregnant women and postpartum women with GDM to
decrease the incidence of DM development in both the mother and the child. Future
health initiatives could be implemented to further educate the general community about
the importance of this health issue.
Diabetes as a whole costs approximately $174 billion per year both directly and
indirectly5. In addition, within a five year span following a pregnancy with GDM, most
cases of DM will occur in these women, giving the study an appropriate amount of time
to make an impact on the lifestyle choices and overall health status of these women 3. It
will also give an accurate representation of the incidence of DM development in women
receiving nutritional counseling as opposed to those who are not. Overall, this research
is important to fund because of the long term health care benefits for women and their
children.

Methods
Population
Women with preexisting diabetes type I or II will be excluded from this trial, as we are
only evaluating the health outcomes of women who received nutritional counseling after
having GDM only. Women under the age of 18 will be excluded due to consent and
potential vulnerable population issues.
Recruitment
Approximately 100 women who have had a recent pregnancy (given birth in the last
three months) who had gestational diabetes (GDM) during her pregnancy will be
recruited to complete this longitudinal randomized control trial. Each group (intervention
and control) would have 50 women. Participants will be recruited by posting flyers in
various hospitals and doctors offices, particularly pediatric offices in the greater Boston,
MA area. Once recruitment is finished, groups will be randomly assigned using an
online random number generator.
Study Design and Data Collection
The data collection and nutrition counseling will be completed at Boston Medical Center.
Each group will come in for an initial visit and then additional visits at 3 months, 6
months, and then once per year for the next 4 years for the duration of the study (8
visits total over the course of five years). During each visit, the control group will be
asked to fill out a questionnaire about eating habits, lifestyle choices, and overall health
since pregnancy. In addition to this, the control group will receive education on MyPlate
and a balanced diet from the graduate assistant.
They will also have their blood glucose and hemoglobin A1C values tested by Bayer
Contour Blood Glucose Monitoring System and the A1C Now system by Bayer.
Hemoglobin A1C levels are being measured as an additional source of information for
overall blood glucose control in addition to the fasting blood glucose measurements of
the participants. The A1C Now system was chosen as a reliable measurement tool
based on research confirming its accuracy and ease of use in addition to daily blood
glucose monitoring6. The fasting blood glucose levels and HgbA1C levels are being
tested to monitor overall blood glucose management currently as well as to monitor
trends over time. The participants will be advised to not eat or drink two hours prior to
their testing to obtain a true fasting blood glucose value. The intervention group will
follow the same timeline, but will receive nutritional counseling from a dietitian at each
visit for type II diabetes prevention due to their previous diagnosis. They will fill out the
same questionnaire as the control group and have their fasting blood glucose and
hemoglobin A1C values tested by Bayer Contour Blood Glucose Monitoring System and
the A1C Now system by Bayer. They will also be advised to not eat or drink two hours
prior to the testing to obtain accurate fasting blood glucose results. This also results in 8
visits total over the course of five years.

Participant Compensation
All participants from both the control and trial groups will be compensated with $15 each
per visit for the first 7 visits, and $25 each for the 8th and final session. The test results
will be evaluated to conclude if nutritional counseling has an effect on the frequency in
which type II diabetes will develop.
Statistical Analysis
Analysis will be completed using SYSTAT 7.0 Software (SPSS, Chicago IL) All values
are expressed as mean standard deviations. All data will be first analyzed for
normality by the DAgostino-Pearson normality test. Using the central limit theorem, it
will be assumed that the data is normal. With this being said, Repeated Measures
ANOVA will be used to analyze results. Results will then be tested for significance using
a P value of <0.05.
Anticipated Results and Conclusions
It is expected that the group with diabetic prevention counseling and intervention will
have lower hemoglobin A1C and fasting blood glucose levels for the duration, and at the
conclusion, of this study in comparison to the control group receiving information on
MyPlate. Such results can be used to develop future educational methods for
gestational diabetes, changes in dietary protocol for the prevention of DM2 in this
population. Using such protocol, changes in reimbursement may also be made in terms
of health insurance and policy. It may also encourage future research in the field to
confirm the results of this study and possibly expand on it.

1. Kim SH, Kim MY, Yang JH, Park SY, Yim CH, Han KO, et al. Nutritional risk factors of
early development of postpartum prediabetes and diabetes in women with gestational
diabetes mellitus. J Nutr 2011; 27:782-788.

2. 2.Tieu J, Bain E, Middleton P, Crowther CA. Interconception care for women with a
history of gestational diabetes for improving maternal and infant outcomes. Cochrane
Database of Systematic Reviews 2013, Issue 6. Art. No.: CD010211. DOI:
10.1002/14651858.CD010211.pub2.

3. Kim C, Newton K, Knopp R. . Gestational diabetes and the incidence of type 2

diabetes: A systematic review. Diabetes Care 2002; 25(10).

4. Gaetke LM, Stuart MA, Truszczynska H. A Single Nutrition Counseling Session with a
Registered Dietitian Improves Short-Term Clinical Outcomes for Rural Kentucky
Patients with Chronic Diseases. Journal of the American Dietetic Association.
2006;106:109-112.

5. Parker AR, Byham-Gray L, Denmark R, Winkle PJ. The Effect of Medical Nutrition
Therapy by a Registered Dietitian Nutritionist in Patients with Prediabetes
Participating in a Randomized Controlled Clinical Research Trial. Journal of the
Academy of Nutrition and Dietetics. 2014;114:1739.

6. Chang A, Frank J, Knaebel, J, Fullam J, Pardo S, Simmons DA. Evaluation of an

over-the-counter glycated hemoglobin (A1C) test kit. J Diabetes Sci Technol.
2010;4(6): 1495-1503.

PERSONNEL
Faculty Member
Physician Assistant
Dietitian
Statistician
Graduate Student
Assistant Professor
Total

Full year salary

82,000
56,000
76,000
18,000
72,000

%effort
0.1
0.25
0.05
0.25
0.15

FRINGE BENEFITS
17% of total personnel
SUPPLIES
A1C Now Self-Check System by Bayer (40 tests x 24 systems x $328.00 per system)
Bayer's Contour Blood Glucose Monitoring System (5 monitors x $5.43)
Bayer Contour Blood Glucose 100 Test Strips (100 strips x 10 boxes x $24.70)
Bayer Microlet Colored Lancets 100 Count (100 x 20 boxes x $8.98)
Sharps Container (20 containersx$4.95)
Latex Gloves (200 gloves/box x20 boxesx$17.89)
Alcohol Swabs (200 swabs/box x 40 boxes x $5.44)
Bandages (100 per box x 20 boxes x $5.80)
Total Supplies
ADMIN
Participant Payments (7 visits x $15 x 100) + (7 visits x $25 x 100)
Printing - Advertising (flyers), handouts for dietitians, and office supplies.
Total Admin

Cost
$8,200.00
$14,000.00
$3,800
$4,500.00
$10,800.00
$ 41,300.00

$ 7,021.00

$7,872.00
$28.00
$247.00
$180.00
$100.00
$358.00
$218.00
$116.00
$9,119.00

$13,000
$1,000.00
$ 14,000.00

TRAVEL
1 professor going to 2 conferences
1 graduate student going to 1 conference
Total Travel

$2,000.00
$1,000.00
$ 3,000.00
Total Direct Costs

INDIRECT COSTS
23.7% Direct Cost

$ 74,440.00
$23,700

Total Funds
Requested

$ 98,140.00

Budget
Budget Justification
Personnel
Partial salaries for a physician assistant, dietitian, statistician, graduate student and assistant
professor will be paid out for this grant for their assistance in data collection and conducting this
study. We are proposing that the dietitian and graduate student be paid 25% of their annual
salary for the dietitians efforts in nutrition counseling for every subject and the graduate
students efforts of data collection and administrative tasks such as participant payments and
printing handouts. We are also proposing a 15% payment of annual salary to the assistant
professor for overseeing the study, recruiting participants, and ensuring that everything runs
smoothly. We are also proposing that the physician assistant be paid 10% of their annual salary
for their efforts of conducting the fasting blood sugar and hemoglobin A1C tests on the subjects.
Finally, we are proposing that the statistician be paid 5% of their annual salary for their efforts in
data analysis of the study. All of the personnel compensation produces a total of $41,300.
Fringe
The total cost of fringe benefits is $7,021.00. The proposed fringe benefits are 17% of personnel
costs, which will include vacation days, sick days, and insurance payments.
Supplies
The total cost of supplies is $8,632. This includes 5 Bayer Contour blood glucose monitors,
1,000 Bayer Contour blood glucose test strips, and 1,000 Bayer Microlet lancets for testing
fasting blood glucose levels. For testing hemoglobin A1C levels, 24 A1C Now Self-Check
System by Bayer will be used, with each system being able to conduct 40 tests before needing
the be replaced. The blood sample necessary for the A1C test will be obtained from the lancets
as well. To maintain sanitary conditions, we will be using sharps containers, latex gloves,
alcohol swabs, and bandages for both tests. All of the supplies used in this study will be ordered
from Amazon.com and there are not any shipping costs associated.
Administration
We are requesting $1,000 in funding to cover administrative costs including the printing of flyers
for participant recruitment, handouts for the dietitian to give to subjects, and office supplies. We
are also requesting $13,000 in funding to compensate participants for their time. We will be

paying each participant $15 per visit for the first seven visits and $25 for the eighth and final
visit.
Travel
Travel costs will be provided to allow the assistant professor and graduate student to attend
conferences to present the findings of this study. The funding requested for the assistant
professor is $2,000, which allows them to travel and attend two conferences. The funding
requested for the graduate student is $1,000, which allowed them to travel and attend one
conference.