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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Behavioral: Dietary and Lifestyle Counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80205
      • Denver Health Eastside Family Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Dietary and Lifestyle Counseling; Dietary and lifestyle education; Peer group support.
No Intervention: Standard of Care; Usual prenatal care consists of regular clinical appointments, pregnancy ultrasounds, and recommendations to use prenatal multivitamins, eat a balanced diet, and remain physically active. Women with a pre-pregnant body mass index > 30 complete early glucose screening (as early as possible after presentation at the clinic) to detect pre-existing diabetes, and all women undergo routine gestational diabetes screening at 24-28 weeks. Women who test positive for pre-existing diabetes or gestational diabetes are referred to a registered dietitian.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational weight gain	Weight change from pre-pregnancy to time of delivery	40 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
Exclusive breastfeeding	Measured as exclusive breastfeeding (no formula, no complementary foods) in the first 6 weeks postpartum	Assessed at 6 weeks postpartum

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Denver Health and Hospital Authority
• Investigators: Principal Investigator: Katherine A Sauder, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: August 5, 2015
• First Submitted That Met QC Criteria: August 6, 2015
• First Posted (Estimate): August 11, 2015

Study Record Updates

• Last Update Posted (Actual): July 13, 2017
• Last Update Submitted That Met QC Criteria: July 10, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Gestational weight gain
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 15-0760

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be made available for this small pilot and feasibility study