Overview

This trial is active, not recruiting.

Condition gestational diabetes mellitus
Treatments 2 online nutrition and exercise education classes, self monitoring of blood glucose levels
Sponsor Joslin Diabetes Center
Collaborator Hoffmann-La Roche
Start date June 2012
End date May 2016
Trial size 30 participants
Trial identifier NCT01681147, CHS 2012-16

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
Standard postpartum care after a pregnancy with gestational diabetes
(Experimental)
Standard postpartum care after a pregnancy with gestational diabetes 2 online nutrition and exercise education classes
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)
Standard postpartum care after a pregnancy with gestational diabetes 2 online nutrition and exercise education classes Self monitoring of blood glucose levels
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
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

Primary Outcomes

Measure
Weight loss
time frame: 1 year postpartum
Postpartum diabetes screening at one year
time frame: 1 year postpartum

Eligibility Criteria

Female participants from 21 years up to 45 years old.

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.)

Additional Information

Official title Barriers to Adherence to Recommended Follow-up in Women With a History of Gestational Diabetes
Principal investigator Florence Brown, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Joslin Diabetes Center.