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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:
ClinicalTrials.gov Identifier:
NCT01681147
First Posted: September 7, 2012
Last Update Posted: March 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Roche Diagnostics
Information provided by (Responsible Party):
Florence Brown, Joslin Diabetes Center
September 4, 2012
September 7, 2012
March 8, 2017
June 2012
November 20, 2017   (Final data collection date for primary outcome measure)
  • Weight loss [ Time Frame: 1 year postpartum ]
  • Postpartum diabetes screening at one year [ Time Frame: 1 year postpartum ]
  • Weight loss
  • Postpartum diabetes screening at one year [ Time Frame: One year postpartum ]
Complete list of historical versions of study NCT01681147 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Intervention Model: Parallel Assignment
Masking: None (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
February 2, 2018
November 20, 2017   (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.)
Sexes Eligible for Study: 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
Roche Diagnostics
Principal Investigator: Florence Brown, MD Joslin Diabetes Center
Joslin Diabetes Center
March 2017

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