Denver Health Eastside Family Health Center
Denver, Colorado, 80205, United States
NCT Number: NCT02520167
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.
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Notify Me18 year–45 year
Female
Interventional
Not applicable
Denver, Colorado, 80205, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dietary and lifestyle education; Peer group support.
Time frame: 40 weeks
Weight change from pre-pregnancy to time of delivery
Time frame: Assessed from 12 weeks gestation through 6 weeks postpartum
Change in daily servings of fruit from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Time frame: Assessed from 12 weeks gestation through 6 weeks postpartum
Change in daily servings of vegetables from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Time frame: Assessed from 12 weeks gestation through 6 weeks postpartum
Change in daily servings of whole grains from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Time frame: Assessed from 12 weeks gestation through 6 weeks postpartum
Change in daily servings of solid fats from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Time frame: Assessed from 12 weeks gestation through 6 weeks postpartum
Change in daily servings of added sugars from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Time frame: Assessed from 12 weeks gestation through 6 weeks postpartum
Change in total estimated energy expenditure from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Time frame: Assessed at 6 weeks postpartum
Measured as exclusive breastfeeding (no formula, no complementary foods) in the first 6 weeks postpartum
University of Colorado, Denver
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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