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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02520167
• Other study ID #: 15-0760
• Status: Completed
• Phase: N/A
• First received: August 5, 2015
• Last updated: July 10, 2017
• Start date: October 2015
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

Behavioral:
• Dietary and Lifestyle Counseling
Dietary and lifestyle education; Peer group support.

Locations

Country	Name	City	State
United States	Denver Health Eastside Family Health Center	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Denver Health and Hospital Authority

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational weight gain	Weight change from pre-pregnancy to time of delivery	40 weeks
Secondary	Maternal fruit intake	Change in daily servings of fruit from early pregnancy to mid-pregnancy, late pregnancy, and postpartum	Assessed from 12 weeks gestation through 6 weeks postpartum
Secondary	Maternal vegetable intake	Change in daily servings of vegetables from early pregnancy to mid-pregnancy, late pregnancy, and postpartum	Assessed from 12 weeks gestation through 6 weeks postpartum
Secondary	Maternal whole grains intake	Change in daily servings of whole grains from early pregnancy to mid-pregnancy, late pregnancy, and postpartum	Assessed from 12 weeks gestation through 6 weeks postpartum
Secondary	Maternal solid fats intake	Change in daily servings of solid fats from early pregnancy to mid-pregnancy, late pregnancy, and postpartum	Assessed from 12 weeks gestation through 6 weeks postpartum
Secondary	Maternal added sugars intake	Change in daily servings of added sugars from early pregnancy to mid-pregnancy, late pregnancy, and postpartum	Assessed from 12 weeks gestation through 6 weeks postpartum
Secondary	Maternal physical activity	Change in total estimated energy expenditure from early pregnancy to mid-pregnancy, late pregnancy, and postpartum	Assessed from 12 weeks gestation through 6 weeks postpartum
Secondary	Exclusive breastfeeding	Measured as exclusive breastfeeding (no formula, no complementary foods) in the first 6 weeks postpartum	Assessed at 6 weeks postpartum