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Barriers to Adherence to Recommended Follow-up in Women With a History of Gestational Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Florence Brown, Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT01681147
First received: September 4, 2012
Last updated: April 1, 2015
Last verified: April 2015

September 4, 2012
April 1, 2015
June 2012
May 2016   (final data collection date for primary outcome measure)
  • Weight loss [ Time Frame: 1 year postpartum ] [ Designated as safety issue: No ]
  • Postpartum diabetes screening at one year [ Time Frame: 1 year postpartum ] [ Designated as safety issue: No ]
  • Weight loss [ Designated as safety issue: No ]
  • Postpartum diabetes screening at one year [ Time Frame: One year postpartum ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01681147 on ClinicalTrials.gov Archive Site
Not Provided
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Barriers to Adherence to Recommended Follow-up in Women With a History of Gestational Diabetes
Barriers to Adherence to Recommended Follow-up in Women With a History of Gestational Diabetes
The purpose of this study is to find out whether women who have had gestational diabetes will make healthier lifestyle choices, achieve weight goals, and complete postpartum care assessments after receiving two online classes on healthy nutrition and exercise classes at 6 weeks - 3 months and at 9 months postpartum.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gestational Diabetes Mellitus
  • Behavioral: 2 online nutrition and exercise education classes
    Two online nutrition and physical activity classes will accessed from a computer, android phone or a tablet. Each class is estimated to last about 1.5- 2 hours and will be accessed 6 weeks-3 months and 9 months
  • Behavioral: Self monitoring of blood glucose levels
    Self monitoring of blood glucose levels four times a day for four consecutive days once a month from 6 weeks-3 months through 9 months post partum
  • No Intervention: Group One
    Standard postpartum care after a pregnancy with gestational diabetes
  • Experimental: Group Two

    Standard postpartum care after a pregnancy with gestational diabetes

    2 online nutrition and exercise education classes

    Intervention: Behavioral: 2 online nutrition and exercise education classes
  • Experimental: Group Three

    Standard postpartum care after a pregnancy with gestational diabetes

    2 online nutrition and exercise education classes

    Self monitoring of blood glucose levels

    Interventions:
    • Behavioral: 2 online nutrition and exercise education classes
    • Behavioral: Self monitoring of blood glucose levels
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
December 2016
May 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Gestational Diabetes
  • Age between 21 and 45 years
  • Preconception BMI 19-40
  • Seen for at least 2 visits in the Diabetes in Pregnancy Program during their pregnancy
  • Singleton pregnancy

Exclusion Criteria:

  • Preexisting diabetes or diabetes diagnosed at the 6 week 75 gram 2 hour OGTT
  • BMI >40
  • Multiple gestation (i.e., twins, triplets, etc.)
Female
21 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01681147
CHS 2012-16
No
Not Provided
Not Provided
Florence Brown, Joslin Diabetes Center
Joslin Diabetes Center
Hoffmann-La Roche
Principal Investigator: Florence Brown, MD Joslin Diabetes Center
Joslin Diabetes Center
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP