An observational study in Hperglycemia, Diabetes Mellitus and Weight Gain, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Withdrawn. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-16.
Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Observational
Background:
Objectives:
Eligibility:
Design:
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.
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Browse Diabetes Mellitus studies →National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 529 studies on the registry; 54 are open to participants now.
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At least 18 years of age.
EXCLUSION CRITERIA:
Gestational Weight Gain
Gestational Diabetes
Complications of Pregnancy and Delivery
No study locations are listed for this record.
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)