Pregnancy
Conditions
Keywords
Gestational weight gain
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.
Interventions
BEHAVIORALDietary and Lifestyle Counseling
Dietary and lifestyle education; Peer group support.
Sponsors
Denver Health and Hospital Authority
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gestational weight gain | 40 weeks | Weight change from pre-pregnancy to time of delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 |
| 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 |
Countries
United States
Outcome results
None listed