Partnership to Improve Nutrition and Adiposity in Prenatal Clinical Care: a Pilot and Feasibility Study



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 45
Updated:4/21/2016
Start Date:October 2015
End Date:December 2016
Contact:Katherine A Sauder, PhD
Email:katherine.sauder@ucdenver.edu
Phone:303-724-8715

Use our guide to learn which trials are right for you!

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.

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.

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
We found this trial at
1
site
?
mi
from
Denver, CO
Click here to add this to my saved trials