A Transgenerational e-Intervention for Gestational Diabetics and Their Offspring (GooD MomS)

August 10, 2015 updated by: University of North Carolina, Chapel Hill

A Transgenerational e-Intervention for Gestational Diabetics and Their Offspring: A Pilot Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifestyle Counseling
Participants will obtain access to an internet-based educational intervention.
Behavioral: Lifestyle Counseling
Participants receive lifestyle counseling on healthy eating and physical activity through an internet based program or self-directed educational program.
Other Names:
  • Healthy Lifestyle
  • Glucose Control
No Intervention: Usual Care (Self-Directed)
Participants receive information via email on health related topics that surround pregnancy, physical activity, nutrition, and gestational diabetes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in glycosylated hemoglobin
Time Frame: Baseline and 36 weeks gestation
Baseline and 36 weeks gestation

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in weight after pregnancy
Time Frame: 6 weeks postpartum to 30 weeks postpartum
6 weeks postpartum to 30 weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Wanda K. Nicholson, MD MPH MBA, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

August 22, 2013

First Submitted That Met QC Criteria

August 22, 2013

First Posted (Estimate)

August 29, 2013

Study Record Updates

Last Update Posted (Estimate)

August 13, 2015

Last Update Submitted That Met QC Criteria

August 10, 2015

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-0827
  • 1R21DK095189-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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