A Transgenerational e-Intervention for Gestational Diabetics and Their Offspring

NCT ID: NCT01931280

Last Updated: 2015-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-03-31

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.

Conditions

Gestational Diabetes Mellitus; Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Lifestyle Counseling

Participants will obtain access to an internet-based educational intervention.

Group Type: EXPERIMENTAL

Lifestyle Counseling

Intervention Type: BEHAVIORAL

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

Usual Care (Self-Directed)

Participants receive information via email on health related topics that surround pregnancy, physical activity, nutrition, and gestational diabetes.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lifestyle Counseling

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Healthy Lifestyle; Glucose Control

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wanda K. Nicholson, MD MPH MBA

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 17554614 (View on PubMed)

Other Identifiers

1R21DK095189-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13-0827

Identifier Type: -

Identifier Source: org_study_id