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GooDMoMS: A Multimodel Pregnancy and Postpartum Intervention for Gestational Diabetics

Primary Purpose

Gestational Diabetes Mellitus, Pregnancy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
lifestyle counseling
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Diabetes Mellitus focused on measuring gestational diabetes

Eligibility Criteria

21 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with gestational diabetes
  • Planning to delivery with the study area

Exclusion Criteria:

  • Pre-existing diabetes (type 1 or type 2 diabetes)
  • Non-English speaking
  • Not planning to delivery in the study area

Sites / Locations

  • University of North Carolina clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Lifestyle counseling

Usual Care Lifestyle counseling

Arm Description

Participants obtain access to an internet-based educational intervention.

Self directed educational intervention

Outcomes

Primary Outcome Measures

Change in glycosylated hemoglobin

Secondary Outcome Measures

Change in weight after pregnancy

Full Information

First Posted
May 15, 2012
Last Updated
September 10, 2014
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT01600534
Brief Title
GooDMoMS: A Multimodel Pregnancy and Postpartum Intervention for Gestational Diabetics
Official Title
GooDMomS: A Multimodel Pregnancy and Postpartum Intervention for Gestational Diabetics
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study includes a behavioral educational intervention that focuses on healthy eating and physical activity during pregnancy and the postpartum among women newly diagnosed with gestational diabetes mellitus (GDM).
Detailed Description
This is a pilot trial in which 30 women newly diagnosed with gestational diabetes are randomized to either one of two groups: 1) active internet intervention or 2) self-directed educational intervention. The primary pregnancy outcome is change in A1C. The primary postpartum outcome is weight.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus, Pregnancy
Keywords
gestational diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Description
Participants obtain access to an internet-based educational intervention.
Arm Title
Usual Care Lifestyle counseling
Arm Type
Other
Arm Description
Self directed educational intervention
Intervention Type
Behavioral
Intervention Name(s)
lifestyle counseling
Other Intervention Name(s)
healthy lifestyle, glucose control
Intervention Description
Participants receive lifestyle counseling on healthy eating and physical activity through an internet-based program or self-directed educational program.
Primary Outcome Measure Information:
Title
Change in glycosylated hemoglobin
Time Frame
Baseline and 36 weeks gestation
Secondary Outcome Measure Information:
Title
Change in weight after pregnancy
Time Frame
6 weeks postpartum to 24 weeks postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with gestational diabetes Planning to delivery with the study area Exclusion Criteria: Pre-existing diabetes (type 1 or type 2 diabetes) Non-English speaking Not planning to delivery in the study area
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wanda Nicholson, MD MPH MBA
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina clinics
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17554614
Citation
Setse R, Grogan R, Cooper LA, Strobino D, Powe NR, Nicholson W. Weight loss programs for urban-based, postpartum African-American women: perceived barriers and preferred components. Matern Child Health J. 2008 Jan;12(1):119-27. doi: 10.1007/s10995-007-0211-6. Epub 2007 Jun 7.
Results Reference
background
PubMed Identifier
27654119
Citation
Nicholson WK, Beckham AJ, Hatley K, Diamond M, Johnson LS, Green SL, Tate D. The Gestational Diabetes Management System (GooDMomS): development, feasibility and lessons learned from a patient-informed, web-based pregnancy and postpartum lifestyle intervention. BMC Pregnancy Childbirth. 2016 Sep 21;16(1):277. doi: 10.1186/s12884-016-1064-z.
Results Reference
derived

Learn more about this trial

GooDMoMS: A Multimodel Pregnancy and Postpartum Intervention for Gestational Diabetics

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