Recent GDM Lifestyle Intervention



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 55
Updated:4/21/2016
Start Date:August 2014
End Date:July 2015

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Lifestyle Intervention for African-American Women: A Pilot Study for Women With a Recent History of Gestational Diabetes (The LIFe Study)

Women with a history of gestational diabetes (GDM) have a substantially increased risk of
developing type 2 diabetes. In fact, 50-70% of these women will go on to develop type 2
diabetes within the 20 years following their GDM-complicated pregnancy. Perceived risk of
developing type 2 diabetes among women with a history of GDM may be particularly important
to altering behavior changes associated with reducing risk. Certain populations have lower
perceived risk of developing type 2 diabetes, despite having a higher prevalence of the
disease. Specifically, African-Americans have a lower perceived risk of developing type 2
diabetes compared to whites, despite their more than doubled risk of developing the disease.
Improvement in awareness of diabetes risk among African-American women at high-risk of
developing type 2 diabetes, such as those with a history of GDM, could reduce future risk of
this disease among this group.

As such, we will conduct a two-armed, pilot randomized controlled trial to evaluate whether
a postpartum diabetes education intervention, incorporating nutrition, exercise, and
diabetes risk assessment can improve diabetes risk awareness, diet, and physical activity
levels at 1-year post-pregnancy among African-American women with a recent history of
gestational diabetes.

We hypothesize that attendance at a 3-month and 9-month postpartum diabetes education class
will:

1. Improve diabetes awareness as measured using the Risk Perception for Developing
Diabetes among women in the intervention group compared to women in the control group
when measuring at 3-months postpartum compared to 12-months postpartum

2. Improve dietary habits and physical activity levels in the intervention group compared
to the control group when measuring at 3-months postpartum compared to 12-months
postpartum

Study subjects will be recruited from the Brigham and Women's Hospital's (BWH)Diabetes and
Pregnancy Program. Obstetricians will assist in the study by introducing the study to women
with gestational diabetes (GDM), who are currently in their third trimester of pregnancy and
asking the women to which race/ethnicity do they self-identify. Those women who
self-identify as Black or African-American will be told by their health care provider that a
Research Assistant from our study would like to speak with them about our study after their
appointment and that the study is only for research purposes and is not mandatory for their
treatment or care at BWH, but is on voluntary basis only.

Our Research Assistant will approach all women who self-identify as African-American and
have GDM, who are in their third trimester (as identified by the obstetrician). For women
who are interested in learning more about the study, but do not have time to hear more about
it during the initial contact, the Research Assistant will obtain their contact information
to describe the study and discuss the woman's possible participation at a later point in
time.

For those women who have time to learn more about the study immediately following their
obstetrics appointment at BWH, our Research Assistant will take women into a private room
within the obstetrics clinic and provide them with general information about the study. If a
woman is interested, we will ask the woman a set of screening questions to assess their
eligibility. The screening questions will not include any personal identifying information
and will only be collected to determine eligibility and response rates. If eligible for
participation in our study, we will collect the eligible woman's contact information and
provide the woman with an informed consent form to be reviewed and signed either at that
time to our Research Assistant or returned to us by mail using a provided stamped, addressed
envelope within 2 weeks of having received the form. Description of the study, confirmation
of contact information, administration of the screening questionnaire, and receipt and
review of consent documents will occur similarly by phone for those women who were not
available to learn more about the study immediately following their obstetrics visit, but
who expressed interests in learning more about the study at a later time point.

Given that women have until 3 months post-pregnancy to be enrolled in our study, we will
also use a flyer with a detachable card and a brochure to try to recruit women during their
6-week postnatal visit, as well as at the time of delivery, during their hospital stay.
These additional recruitment time points will maximize recruitment efforts. Recruitment at
the 6-week postnatal visit will be similar to that described above for the third trimester
clinic visit. For those women that we attempt to recruit at the time of delivery, we will
have an obstetrician notify us of a delivering woman, who has self-identified as
African-American and had GDM during her recent pregnancy. Our Research Assistant will
approach women on the Labor and Delivery floor after the woman's delivery. At this time the
study will be explained to her and the woman will be asked to answer screening questions, if
she is interested in the study. An informed consent will be provided, if the woman is
eligible. The woman can either complete the informed consent at that time or return it to
our study staff within 2 weeks.

Upon return of the signed informed consent form, we will enroll the woman in the study and
randomize her to receive either the study intervention or standard care. We will ensure
balance in this process through the use of block randomization. At this time point, our
research assistant will assist with scheduling the woman's 6-week postpartum follow-up
visit, which is a part of her standard medical care. This assistance with scheduling, will
aid in making sure that the potential study participant receives her 6-week postpartum
diabetes screening. If she fails the screening, then she will be notified by a study
clinician and withdrawn from the study.

For women who do not return the consent form within 2-weeks of having initially received it
from our research assistant, we will re-contact the woman to follow-up with her about her
interest in participating in the study. Eligible women will be re-contacted either by phone
or e-mail, based on the woman's preferred method of contact, up to three times, to obtain
the informed consent. After the third unsuccessful re-contact, we will stop attempts to
obtain the consent form. We will also not re-contact a woman, if they state they are no
longer interested in the study.

Again, as a part of enrollment into the study, we will obtain e-mail addresses and mailing
addresses of our study participants (see Script C1). We will also obtain telephone
information in order to call or text the woman, if this is her preferred contact method. At
3-months we will send a secure web link for completion of the 3-months web-based
questionnaire to be completed by the woman. For women without internet access or those who
do not wish to complete the questionnaire online, we will mail a paper-version of the
questionnaire at 3-months postpartum. Likewise, a web link or paper questionnaires will be
sent at 6-months, 9-months, and 12-months postpartum. If we have not received the completed
questionnaire, we will contact the study participant by phone to determine whether she
received the initial questionnaire and if she has any questions. All women enrolled in the
study (both the intervention group and standard care group) will be asked to complete these
questionnaires. We will also send a text reminder for those women who listed text as a
preferred method of contact.

For those women enrolled in the intervention arm, the research assistant will contact them
via phone to schedule them for their 3-month and 9-month class to be held at a local
community centers. Two weeks before the class we will send a reminder card either via
e-mail, text message, or postal mail. Two days before the class our Research Assistant will
contact the women by phone to remind them of the class, location, and time. Women will also
be reminded at this time to bring a favorite recipe to the class.

The intervention group will attend classes mentioned at the aforementioned centers. Each
class will take 2-hours and be conducted by a Collaborative Institutional Training
Initiative (CITI) certified registered nutritionist familiar with working in the GDM
population and with extensive experience working in the African-American community. Both
classes will include a cooking demonstration. In addition, the class will include a tour of
a local supermarket to aid women in identifying healthy food choices. The classes will cover
the following material:

3-month class:

1. Introductions: Nutritionist/Life coach will introduce herself and will encourage others
to introduce themselves on a first name basis only.

2. Overview of class and class guidelines: Nutritionist/Life coach will provide an
overview of the material to be covered as well as class guidelines

3. Diabetes Risk Awareness: Focus on diabetes risk factors, as well as symptoms of
diabetes, and lifestyle factors that can reduce diabetes risk.

4. Review Weight Loss Goals: Subjects will weigh in at each visit: Discuss the benefit of
weight loss on the reduction of risk of future type 2 diabetes in the mom.

5. Good Nutrition, Healthy Plate and Portions: Review portion sizes using handouts. There
will also be a focus on adding fruits and vegetables, learning about healthy versus
unhealthy fat, as well as label reading.

6. Infant feeding: Review/discuss the benefits of breastfeeding for mom and the baby
including reducing maternal weight retention, and reducing infant and child obesity.
Review optimal timing of introduction of solid foods and types of foods healthy for
your child.

7. Ways to reduce your diabetes risk: Discussion of lifestyle factors that can reduce your
diabetes risk, including physical activity and sleep.

8. Exercise Basics: Review options for moderate intensity cardiovascular exercise and
strength training, including walking and the use of resistance bands, and discuss
exercise goals.

9. Making Your Recipes Healthy: Focus on adapting popular recipes, as well as those of
study participants to make them healthy. Participants will be asked to submit one
favorite family recipe at the beginning of the study. The group will work together to
modify all the recipes using healthy substitutions.

10. Cooking Demonstration: The nutritionist/group teacher will prepare a healthy meal
during the class time. This will showcase healthy food choices, measuring and food
preparation skills, as well as methods of cooking. Class participants will be welcomed
to partake in the meal, once prepared.

9 month class:

1. Review of Diabetes and Diabetes Risk Awareness: Review diabetes risk factors,
prevention measures used to reduce diabetes risk, and signs and symptoms of diabetes.

2. Review Weight Loss Goals: Subjects will weigh in at this time point and discuss the
benefits of weight loss on the reduction of risk of future type 2 diabetes in the mom.

3. Eating Healthy, Healthy Plate and Portions: Review portion sizes using handouts. We
will re-emphasize the importance of adding fruits and vegetables, and discuss healthy
and unhealthy fats based on current dietary habits. Also, focus on label reading

4. Supermarket Smarts, Label reading and Dining Out: Tips for making healthy choices at
the grocery store. Review how to make healthier choices when dining out, with
instruction including a sample restaurant menu. In addition, participants will become
familiar with how to read food labels.

5. Assessment of barriers to healthy lifestyle: Participants will discuss with
nutritionist/group teacher issues surrounding healthy eating, barriers to physical
activity and other healthy lifestyle behaviors associated with reduced risk of
diabetes. Discussion will focus on solutions to overcoming these barriers.

6. Cooking Demonstration: The nutritionist/group teacher will provide a prepare and cook a
health meal during the class time. This will showcase healthy food choices, measuring
and food preparation skills, as well as methods of cooking. Class participants will be
welcomed to partake in the meal, once prepared.

For women in the intervention group, onsite childcare at the Boys and Girls Club will be
made a possible option through the use of already-certified childcare providers. We will
also offer women the option of covering childcare at home for 4-hours (to cover commuting
time, as well as the time for the 2-hour class) per session. Description of this
compensation will be discussed below. If necessary, women will be allowed to bring their
infant children to the class to ensure the woman is able to attend.

Upon completion of the class, the woman will be asked a set of qualitative questions
regarding the class information and structure to better inform a larger, future
intervention.

Inclusion Criteria:

- Have gestational diabetes during current or most recent pregnancy

- Be less than 3 months postpartum

- Age between >=18 years

- Preconception BMI <45

- Singleton pregnancy

- Self-identified Black/African-American race/ethnicity

- Speak English

Exclusion Criteria:

- Preexisting diabetes or diabetes diagnosed at the 6 week 75 gram oral glucose
tolerance test.

- BMI >=45.

- Multiple gestation (i.e. twins, triplets, etc.)
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