Barriers to Adherence to Recommended Follow-up in Women With a History of Gestational Diabetes
Condition: Gestational Diabetes Mellitus
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to find out whether women who have had gestational diabetes
      mellitus (GDM) 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.
    

Detailed description: 
      For this pilot study, we propose to conduct a 3-grouped randomized controlled trial to
      evaluate whether a 1 ½ to 2 hour on-line nutrition and physical activity intervention +/-
      block testing of blood glucoses fasting and 2 hours after each meal for 4 days/month from
      starting at 3 months postpartum and concluding at 9 months postpartum will: 1) improve
      adherence to the receipt of diabetes screening at 12 months postpartum through the
      recommended 75 gram 2 hour oral glucose tolerance test (OGTT) or fasting blood glucose test,
      2) lower glucose values on the 75 gram 2 hour oral glucose tolerance test or fasting blood
      glucose test and 3) improve attainment of weight loss targets among women with a recent
      history of GDM.

      Patients will participate in an online nutrition and physical activity class from 6 weeks to
      3 months and 9 months for women assigned to both groups 2 and 3. For those women assigned to
      group 3, they will also do block testing using an assigned blood glucose meter and test
      strips 4 times a day for 4 consecutive days each month, starting at 3 months and ending at 9
      months. Women will have the option of submitting meter blood glucose data via e-mailed logs
      or downloading directly to the clinic using Diasend software. Once downloaded, the Diasend
      software will create a PDF document with all recorded blood glucose values.

      For purposes of this study, we will obtain a Diasend account specific to this study, which
      will allow women to download blood glucose information with an anonymous unique identifier
      that can be accessed by the study's Principal Investigator and the Collaborative
      Institutional Training Initiative (CITI)-certified, International Review Board (IRB)-approved
      research assistant. Upon accessing the PDF document with the blood glucose meter information,
      both the PI and the Research Assistant can link blood glucose data with questionnaire and
      other health information collected in this study through the unique identifiers.
    

Intervention name(s): 2 online nutrition and exercise education classes; Self monitoring of blood glucose levels
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gestational Diabetes; postpartum; nutrition; exercise