Back to resultsA Transgenerational e-Intervention for Gestational Diabetics and Their Offspring (GooD MomS)
Primary Purpose
Gestational Diabetes Mellitus, Pregnancy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Counseling
Sponsored by
About this trial
This is an interventional prevention trial for Gestational Diabetes Mellitus focused on measuring Gestational diabetes
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with gestational diabetes Confirmed singleton pregnancy 24-32 weeks gestation age Planning to deliver within the study area
Exclusion Criteria:
- Pre-existing diabetes (type 1 or 2) Non-english speaking Not planning to deliver in the study area
Sites / Locations
- University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Lifestyle Counseling
Usual Care (Self-Directed)
Arm Description
Participants will obtain access to an internet-based educational intervention.
Participants receive information via email on health related topics that surround pregnancy, physical activity, nutrition, and gestational diabetes.
Outcomes
Primary Outcome Measures
Change in glycosylated hemoglobin
Secondary Outcome Measures
Change in weight after pregnancy
Full Information
NCT ID
NCT01931280
First Posted
August 22, 2013
Last Updated
August 10, 2015
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT01931280
Brief Title
A Transgenerational e-Intervention for Gestational Diabetics and Their Offspring
Acronym
GooD MomS
Official Title
A Transgenerational e-Intervention for Gestational Diabetics and Their Offspring: A Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study includes a behavioral educational intervention that focuses on healthy eating, physical activity and glucose management during pregnancy and post partum among women newly diagnosed with gestational diabetes mellitus (GDM).
Detailed Description
This is a pilot trial in which 50 women newly diagnosed with gestational diabetes are randomized to either one of two groups: 1) active internet intervention or 2)Usual Care (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
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle Counseling
Arm Type
Experimental
Arm Description
Participants will obtain access to an internet-based educational intervention.
Arm Title
Usual Care (Self-Directed)
Arm Type
No Intervention
Arm Description
Participants receive information via email on health related topics that surround pregnancy, physical activity, nutrition, and gestational diabetes.
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 30 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 Confirmed singleton pregnancy 24-32 weeks gestation age Planning to deliver within the study area
Exclusion Criteria:
Pre-existing diabetes (type 1 or 2) Non-english speaking Not planning to deliver in the study area
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wanda K. 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 at Chapel Hill
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
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A Transgenerational e-Intervention for Gestational Diabetics and Their Offspring
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