Healthy Lifestyle in Pregnancy
Healthy Lifestyle in Pregnancy
Background:

 - 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.

 Objectives:

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

 Eligibility:

 -  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.

 Design:

 -  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
 feelings.
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.
-  INCLUSION CRITERIA:

 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.

 EXCLUSION CRITERIA:

 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.