Gestational Diabetes Mellitus, Pregnancy
Conditions
Keywords
Gestational diabetes
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.
Interventions
BEHAVIORALLifestyle Counseling
Participants receive lifestyle counseling on healthy eating and physical activity through an internet based program or self-directed educational program.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in glycosylated hemoglobin | Baseline and 36 weeks gestation |
Secondary
| Measure | Time frame |
|---|---|
| Change in weight after pregnancy | 6 weeks postpartum to 30 weeks postpartum |
Countries
United States
Outcome results
None listed