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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Hoffmann-La Roche

Information provided by (Responsible Party):

Florence Brown, Joslin Diabetes Center

ClinicalTrials.gov Identifier:

NCT01681147

First received: September 4, 2012

Last updated: April 1, 2015

Last verified: April 2015

History of Changes

Purpose

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	Intervention
Gestational Diabetes Mellitus	Behavioral: 2 online nutrition and exercise education classes Behavioral: Self monitoring of blood glucose levels


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Barriers to Adherence to Recommended Follow-up in Women With a History of Gestational Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Blood Sugar Exercise and Physical Fitness Postpartum Care

U.S. FDA Resources

Further study details as provided by Joslin Diabetes Center:

Primary Outcome Measures:

Weight loss [ Time Frame: 1 year postpartum ] [ Designated as safety issue: No ]
Postpartum diabetes screening at one year [ Time Frame: 1 year postpartum ] [ Designated as safety issue: No ]


Estimated Enrollment:	30
Study Start Date:	June 2012
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	May 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	21 Years to 45 Years (Adult)
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681147

Locations


United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

Joslin Diabetes Center

Hoffmann-La Roche

Investigators


Principal Investigator:	Florence Brown, MD	Joslin Diabetes Center

More Information


Responsible Party:	Florence Brown, Clinic Physician, Co-Director of the Joslin and Beth Israel Deaconness Diabetes in Pregnancy Program, Joslin Diabetes Center
ClinicalTrials.gov Identifier:	NCT01681147 History of Changes
Other Study ID Numbers:	CHS 2012-16
Study First Received:	September 4, 2012
Last Updated:	April 1, 2015
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 27, 2016

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