Healthy Lifestyle in Pregnancy

Status:Not yet recruiting
Conditions:Obesity Weight Loss, Diabetes
Therapuetic Areas:Endocrinology
Age Range:18 - Any
Start Date:March 2012
Contact:William C Knowler, M.D.
Phone:(602) 200-5206

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- Women can gain too much weight or develop diabetes during pregnancy. If the mother is
overweight or has diabetes during pregnancy, her baby may also be at risk of being
overweight or developing diabetes. A woman s chance of getting diabetes increases if her
parents or family members are overweight or have diabetes. Poor diet and exercise habits can
also lead to weight gain and diabetes. Researchers want to study how best to improve the
health of pregnant women and their children. They will do so by providing healthy lifestyle
counseling for women receiving prenatal care at the Phoenix Indian Medical Center.


- To study the effectiveness of healthy lifestyle counseling for overweight and/or diabetic
pregnant women.


- Women at least 18 years of age who will receive pregnancy care at the Phoenix Indian
Medical Center.

- Participants must be overweight or obese. They may or may not have diabetes.


- Participants will receive standard prenatal care from the midwives, doctors, and
dietitians at the Phoenix Indian Medical Center.

- Participants will work with National Institutes of Health staff for about 2 hours every
week. These sessions may include phone calls, home visits, or group meetings.

- Participants will have a total of nine measurement visits. The first visit will be at
or before 16 weeks of pregnancy. The next three visits will be within a week of the
first visit. Another four visits will take place between 23 and 28 weeks of pregnancy.

- Participants will have different tests through their pregnancy. They will wear heart
monitors and wrist monitors to measure heart rate and movement. They will provide
information on their eating habits, physical activity, and mood and feelings during
pregnancy. Blood samples will be collected to measure blood glucose (sugar) levels.

- Participants will receive counseling on healthy eating and physical activity habits.
They will be encouraged to invite friends or family members to learn more about healthy
lifestyle choices.

- The study will end with the final visit about 6 to 8 weeks after giving birth. A final
blood sample will be collected. Participants will be asked questions about mood and

American Indians are at high risk for developing type 2 diabetes mellitus (T2DM) and its
complications. Major factors responsible for this finding include obesity and intrauterine
exposure to diabetes; the latter increases the risk of diabetes in the offspring
particularly during childhood and adolescence. This study is designed to evaluate the
feasibility of conducting an intensive lifestyle intervention (ILI) in adult (age greater
than or equal to 18 years) pregnant women of any race or ethnicity who are eligible for
prenatal care at Phoenix Indian Medical Center (PIMC). Most of these women or their fetuses
will be of American Indian heritage. Interventions will be provided to overweight and obese
pregnant women who may have diabetes, develop gestational diabetes (GDM), or be at high risk
of developing diabetes. We will evaluate our ability to maintain engagement and motivate
adoption of a healthy diet and increased physical activity. The lifestyle intervention will
be patterned after the Diabetes Prevention Program (DPP) that prevented or delayed the onset
of diabetes in non pregnant adults; the interventions will be modified to be appropriate in
pregnancy. A major modification will be to encourage managed weight gain instead of weight
loss. For women who have or develop diabetes, interventions will include coaching to
optimize glycemic control. In this protocol, we will seek to identify strategies that can
successfully accomplish these goals. Results from this study will permit us to formulate
appropriate intervention strategies for a large randomized clinical study to evaluate the
impact of an intensive lifestyle intervention on pregnant women and their offspring.

The project will be conducted in collaboration between the nurse midwifery and obstetrics
services at Phoenix Indian Medical Center (PIMC) and the National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK). Important feasibility measures include evaluating our
ability to enroll and retain pregnant women in a lifestyle intervention program and collect
serial measures of gestational weight and glucose, objective measures of physical activity,
and nutritional questionnaires.


1. At least 18 years of age.

2. Receive prenatal care at the nurse midwifery/obstetrics service of PIMC and plan
to continue receiving such care throughout the pregnancy.

3. Are able to have an OGTT prior to 16 weeks gestation (if diabetes was not
previously diagnosed). Hyperemesis can preclude some pregnant women from
successfully completing the OGTT; these women will not be excluded if the
fasting blood samples can be obtained. Pregnant women with previously diagnosed
diabetes are eligible if measures of glycemia (FPG, HbA1c, glycated albumin) are
completed prior to 16 weeks gestation.

4. Estimated prenatal BMI > 25 kg/m2.

5. Able to commit the time required for the interventions and follow-up.

6. Able and willing to provide informed consent.


1. Contraindication to aerobic or resistance exercise (ACOG, 2002).

2. Twin or multiple gestation.

3. Severe anemia, uncontrolled asthma, uncontrolled hypertension, cardiac disease, or
any condition that requires follow-up at specialty care clinics outside of PIMC
(e.g., pregnancies at high risk for maternal or fetal demise).

4. Any condition that in the opinion of the investigators would interfere with consent,
treatment, or follow-up.
We found this trial at
Phoenix, Arizona 85014
Phoenix, AZ
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