Healthy Lifestyle in Pregnancy

NCT01585454 | Withdrawn

• 2 other identifiers: 99991210812-DK-N108
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hperglycemia; Diabetes Mellitus; Weight Gain

Keywords

Pregnancy; Diabetes Mellitus; Weight Gain; Diabetes

Outcome Measures

Primary Outcomes (1)

• Gestational Weight Gain

Secondary Outcomes (2)

• Gestational Diabetes

• Complications of Pregnancy and Delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age.
• Receive prenatal care at the nurse midwifery/obstetrics service of PIMC and plan to continue receiving such care throughout the pregnancy.
• 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.
• Estimated prenatal BMI \>25 kg/m2.
• Able to commit the time required for the interventions and follow-up.
• Able and willing to provide informed consent.

You may not qualify if:

• Contraindication to aerobic or resistance exercise (ACOG, 2002).
• Twin or multiple gestation.
• 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).
• Any condition that in the opinion of the investigators would interfere with consent, treatment, or follow-up.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Related Publications (3)

• Cedergren MI. Optimal gestational weight gain for body mass index categories. Obstet Gynecol. 2007 Oct;110(4):759-64. doi: 10.1097/01.AOG.0000279450.85198.b2.

  PMID: 17906006 BACKGROUND

• Dabelea D, Hanson RL, Lindsay RS, Pettitt DJ, Imperatore G, Gabir MM, Roumain J, Bennett PH, Knowler WC. Intrauterine exposure to diabetes conveys risks for type 2 diabetes and obesity: a study of discordant sibships. Diabetes. 2000 Dec;49(12):2208-11. doi: 10.2337/diabetes.49.12.2208.

  PMID: 11118027 BACKGROUND

• International Association of Diabetes and Pregnancy Study Groups Consensus Panel; Metzger BE, Gabbe SG, Persson B, Buchanan TA, Catalano PA, Damm P, Dyer AR, Leiva Ad, Hod M, Kitzmiler JL, Lowe LP, McIntyre HD, Oats JJ, Omori Y, Schmidt MI. International association of diabetes and pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Diabetes Care. 2010 Mar;33(3):676-82. doi: 10.2337/dc09-1848. No abstract available.

  PMID: 20190296 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Weight Gain

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• William C Knowler, M.D.

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2012
• First Posted: April 25, 2012
• Study Start: March 27, 2012
• Study Completion: January 20, 2016
• Last Updated: December 16, 2019

Record last verified: 2016-01-20