A Transgenerational e-Intervention for Gestational Diabetics and Their Offspring
GooD MomS
2 other identifiers
interventional
50
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2013
CompletedFirst Posted
Study publicly available on registry
August 29, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedAugust 13, 2015
September 1, 2014
1.5 years
August 22, 2013
August 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in glycosylated hemoglobin
Baseline and 36 weeks gestation
Secondary Outcomes (1)
Change in weight after pregnancy
6 weeks postpartum to 30 weeks postpartum
Study Arms (2)
Lifestyle Counseling
EXPERIMENTALParticipants will obtain access to an internet-based educational intervention.
Usual Care (Self-Directed)
NO INTERVENTIONParticipants receive information via email on health related topics that surround pregnancy, physical activity, nutrition, and gestational diabetes.
Interventions
Participants receive lifestyle counseling on healthy eating and physical activity through an internet based program or self-directed educational program.
Eligibility Criteria
You may qualify if:
- Diagnosed with gestational diabetes Confirmed singleton pregnancy 24-32 weeks gestation age Planning to deliver within the study area
You may not qualify if:
- Pre-existing diabetes (type 1 or 2) Non-english speaking Not planning to deliver in the study area
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Related 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. doi: 10.1007/s10995-007-0211-6. Epub 2007 Jun 7.
PMID: 17554614BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wanda K. Nicholson, MD MPH MBA
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2013
First Posted
August 29, 2013
Study Start
September 1, 2013
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
August 13, 2015
Record last verified: 2014-09