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
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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 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 |

Arm | Intervention/treatment |
---|---|
No Intervention: Group One
Standard postpartum care after a pregnancy with gestational diabetes
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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
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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
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- Weight loss [ Time Frame: 1 year postpartum ]
- Postpartum diabetes screening at one year [ Time Frame: 1 year postpartum ]

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

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
United States, Massachusetts | |
Joslin Diabetes Center | |
Boston, Massachusetts, United States, 02215 |
Principal Investigator: | Florence Brown, MD | Joslin Diabetes Center |
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 |