Expired Study
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Denver, Colorado 80205


Purpose:

This study will pilot and assess feasibility of a prenatal intervention for obese pregnant women based on the Diabetes Prevention Program (DPP). Intervention group participants will meet with a clinic dietitian for 15 minutes at every prenatal appointment to complete a DPP-based curriculum and receive breastfeeding education. Control group participants will receive usual prenatal care. Outcomes include reach and dose of the intervention, gestational weight gain, dietary intake, physical activity, and breastfeeding in the first 6 weeks postpartum.


Study summary:

This study will pilot and test feasibility of a prenatal lifestyle intervention designed to limit gestational weight gain and prevent gestational diabetes. The intervention is based on the Diabetes Prevention Program lifestyle intervention, will include prenatal breastfeeding education and online peer group support, and will be integrated into the participants' regular prenatal appointments. Women (n=24) will be enrolled in early pregnancy. After baseline assessments (demographics, maternal diet, physical activity, mental health), women randomized equally to the intervention or usual care conditions. Further data collection will occur at approximately 24 weeks gestation, 36 weeks gestation, and 6 weeks postpartum, and clinical data (weight, pregnancy and obstetric complications) will be abstracted from medical records at the end of the study. Outcomes include reach and dose of the intervention, gestational weight gain, dietary intake, physical activity, and breastfeeding in the first 6 weeks postpartum. The investigators hypothesize that the intervention will reduce gestational weight gain, improve maternal dietary intake, increase total energy expenditure, and increase breastfeeding exclusivity in the first 6 weeks postpartum.


Criteria:

Inclusion Criteria: - Singleton pregnancies of <12 weeks gestation - Pre-pregnant body mass index >=30 - Speak and understand English - Plan to continue care at the clinic through pregnancy and postpartum Exclusion Criteria: - Pre-existing diabetes - History of serious chronic illnesses - History of prior gestational diabetes - Prior delivery at <37 weeks gestation - Prior delivery of infant weighing <2500g


NCT ID:

NCT02520167


Primary Contact:

Principal Investigator
Katherine A Sauder, PhD
University of Colorado, Denver


Backup Contact:

N/A


Location Contact:

Denver, Colorado 80205
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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