- Ages Eligible for Study
- 18 years and up
- Genders Eligible for Study
Pregnancy, Diabetes Mellitus, Weight Gain, and Diabetes
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01585454
Overall Contact Backup
NIDDK, PhoenixPhoenix, Arizona United States(Recruiting)