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

Primary Purpose

Pregnancy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary and Lifestyle Counseling
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy focused on measuring Gestational weight gain

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Denver Health Eastside Family Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dietary and Lifestyle Counseling

Standard of Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Gestational weight gain
Weight change from pre-pregnancy to time of delivery

Secondary Outcome Measures

Maternal fruit intake
Change in daily servings of fruit from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Maternal vegetable intake
Change in daily servings of vegetables from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Maternal whole grains intake
Change in daily servings of whole grains from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Maternal solid fats intake
Change in daily servings of solid fats from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Maternal added sugars intake
Change in daily servings of added sugars from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Maternal physical activity
Change in total estimated energy expenditure from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Exclusive breastfeeding
Measured as exclusive breastfeeding (no formula, no complementary foods) in the first 6 weeks postpartum

Full Information

First Posted
August 5, 2015
Last Updated
July 10, 2017
Sponsor
University of Colorado, Denver
Collaborators
Denver Health and Hospital Authority
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1. Study Identification

Unique Protocol Identification Number
NCT02520167
Brief Title
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

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Denver Health and Hospital Authority

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy
Keywords
Gestational weight gain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary and Lifestyle Counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dietary and Lifestyle Counseling
Intervention Description
Dietary and lifestyle education; Peer group support.
Primary Outcome Measure Information:
Title
Gestational weight gain
Description
Weight change from pre-pregnancy to time of delivery
Time Frame
40 weeks
Secondary Outcome Measure Information:
Title
Maternal fruit intake
Description
Change in daily servings of fruit from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Time Frame
Assessed from 12 weeks gestation through 6 weeks postpartum
Title
Maternal vegetable intake
Description
Change in daily servings of vegetables from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Time Frame
Assessed from 12 weeks gestation through 6 weeks postpartum
Title
Maternal whole grains intake
Description
Change in daily servings of whole grains from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Time Frame
Assessed from 12 weeks gestation through 6 weeks postpartum
Title
Maternal solid fats intake
Description
Change in daily servings of solid fats from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Time Frame
Assessed from 12 weeks gestation through 6 weeks postpartum
Title
Maternal added sugars intake
Description
Change in daily servings of added sugars from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Time Frame
Assessed from 12 weeks gestation through 6 weeks postpartum
Title
Maternal physical activity
Description
Change in total estimated energy expenditure from early pregnancy to mid-pregnancy, late pregnancy, and postpartum
Time Frame
Assessed from 12 weeks gestation through 6 weeks postpartum
Title
Exclusive breastfeeding
Description
Measured as exclusive breastfeeding (no formula, no complementary foods) in the first 6 weeks postpartum
Time Frame
Assessed at 6 weeks postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine A Sauder, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver Health Eastside Family Health Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be made available for this small pilot and feasibility study

Learn more about this trial

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

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