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

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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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
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