A Transgenerational e-Intervention for Gestational Diabetics and Their Offspring

Pregnancy Clinical Trial

— GooD MomS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01931280
• Other study ID #: 13-0827
• Secondary ID: 1R21DK095189-01
• Status: Completed
• Phase: N/A
• First received: August 22, 2013
• Last updated: August 10, 2015
• Start date: September 2013
• Est. completion date: March 2015

Study information

• Verified date: September 2014
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal GovernmentUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes Mellitus
• Pregnancy

Intervention

Behavioral:
• Lifestyle Counseling
Participants receive lifestyle counseling on healthy eating and physical activity through an internet based program or self-directed educational program.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Epub 2007 Jun 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in glycosylated hemoglobin		Baseline and 36 weeks gestation	No
Secondary	Change in weight after pregnancy		6 weeks postpartum to 30 weeks postpartum	No