Partnership to Improve Nutrition and Adiposity in Prenatal Clinical Care: a Pilot and Feasibility Study
- Conditions
- Pregnancy
- Interventions
- Behavioral: Dietary and Lifestyle Counseling
- Registration Number
- NCT02520167
- Lead Sponsor
- University of Colorado, Denver
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dietary and Lifestyle Counseling Dietary and Lifestyle Counseling Women randomized to the intervention group will meet with a dietary counselor for 15 minutes at every prenatal appointment. They will receive a dietary and lifestyle curriculum based on the Diabetes Prevention Program curriculum (11 lessons) with one additional lesson providing prenatal breastfeeding education. They will also have access to a private online Facebook page for additional education and peer group support.
- Primary Outcome Measures
Name Time Method Gestational weight gain 40 weeks Weight change from pre-pregnancy to time of delivery
- Secondary Outcome Measures
Name Time Method Maternal fruit intake 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
Maternal vegetable intake 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
Maternal added sugars intake 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
Maternal whole grains intake 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
Maternal solid fats intake 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
Maternal physical activity 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
Exclusive breastfeeding Assessed at 6 weeks postpartum Measured as exclusive breastfeeding (no formula, no complementary foods) in the first 6 weeks postpartum
Trial Locations
- Locations (1)
Denver Health Eastside Family Health Center
🇺🇸Denver, Colorado, United States