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

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ClinicalTrials.gov Identifier: NCT01681147
Recruitment Status : Active, not recruiting
First Posted : September 7, 2012
Last Update Posted : December 11, 2017
Sponsor:
Collaborator:
Roche Diagnostics
Information provided by (Responsible Party):
Joslin Diabetes Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus Behavioral: 2 online nutrition and exercise education classes Behavioral: Self monitoring of blood glucose levels Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Barriers to Adherence to Recommended Follow-up in Women With a History of Gestational Diabetes
Study Start Date : June 2012
Estimated Primary Completion Date : January 20, 2018
Estimated Study Completion Date : March 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

Arms and Interventions
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Arm Intervention/treatment
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

 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
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

 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


Outcome Measures
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Primary Outcome Measures :
  1. Weight loss [ Time Frame: 1 year postpartum ]
  2. Postpartum diabetes screening at one year [ Time Frame: 1 year postpartum ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681147


Locations
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Joslin Diabetes Center
Roche Diagnostics
Investigators
Principal Investigator: Florence Brown, MD Joslin Diabetes Center
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT01681147     History of Changes
Other Study ID Numbers: CHS 2012-16
First Posted: September 7, 2012    Key Record Dates
Last Update Posted: December 11, 2017
Last Verified: December 2017

Keywords provided by Joslin Diabetes Center:
Gestational Diabetes
postpartum
nutrition
exercise

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications