Clinical trial NCT02520167: Partnership to Improve Nutrition and Adiposity in Prenatal Clinical Care: a Pilot and Feasibility Study
Official title: Partnership to Improve Nutrition and Adiposity in Prenatal Clinical Care: a Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Gestational weight gain
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Denver Health and Hospital Authority
First posted: 2015-08-11
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Gestational weight gain
timeFrame: 40 weeks
Secondary outcomes:
measure: Maternal fruit intake
timeFrame: Assessed from 12 weeks gestation through 6 weeks postpartum
measure: Maternal vegetable intake
timeFrame: Assessed from 12 weeks gestation through 6 weeks postpartum
measure: Maternal whole grains intake
timeFrame: Assessed from 12 weeks gestation through 6 weeks postpartum
measure: Maternal solid fats intake
timeFrame: Assessed from 12 weeks gestation through 6 weeks postpartum
measure: Maternal added sugars intake
timeFrame: Assessed from 12 weeks gestation through 6 weeks postpartum
measure: Maternal physical activity
timeFrame: Assessed from 12 weeks gestation through 6 weeks postpartum
measure: Exclusive breastfeeding
timeFrame: Assessed at 6 weeks postpartum
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Eastside Family Health Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Katherine A Sauder, PhD
role: PRINCIPAL_INVESTIGATOR
References: