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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Joslin Diabetes Center
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: March 25, 2014
Last verified: March 2014
  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 6weeks-3 months and at 9 months.


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 Regular Follow-up in Women With a History of Gestational Diabetes

Resource links provided by NLM:


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: June 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
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

Contacts
Contact: Fatimah Bello, MBChB, MPH 617-309-2465 Fatimah.Bello@joslin.harvard.edu

Locations
United States, Massachusetts
Joslin Diabetes Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Fatimah Bello, MBChB, MPH    617-309-2465    Fatimah.Bello@joslin.harvard.edu   
Contact: Florence Brown, MD         
Principal Investigator: Florence M Brown, MD         
Sponsors and Collaborators
Joslin Diabetes Center
Hoffmann-La Roche
Investigators
Principal Investigator: Florence Brown, MD Joslin Diabetes Center
  More Information

No publications provided

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: March 25, 2014
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 October 02, 2014