Text Size

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

This study is currently recruiting participants.
Verified September 2012 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: September 6, 2012
Last verified: September 2012
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 education on healthy nutrition and exercise.


Condition Intervention
Gestational Diabetes Mellitus
 Behavioral: Group nutrition visits
Behavioral: Blood glucose testing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
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:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Joslin Diabetes Center:

Primary Outcome Measures:
  • Weight loss [ Designated as safety issue: No ]
  • Postpartum diabetes screening at one year [ Time Frame: one year postpartum ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: June 2012
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 plus group nutrition and physical activity education classes
 Behavioral: Group nutrition visits
Group classes held for 1.5 hours at the Joslin Diabetes Center
Experimental: Group Three
Standard postpartum care after a pregnancy with gestational diabetes, group nutrition and physical activity education classes plus blood glucose testing
 Behavioral: Group nutrition visits
Group classes held for 1.5 hours at the Joslin Diabetes Center
Behavioral: Blood glucose testing
Measure blood glucose levels four times a day for four consecutive days once a month

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

Contacts
Contact: Margaret Beste, BA 617-309-2465 meg.beste@joslin.harvard.edu

Locations
United States, Massachusetts
Joslin Diabetes Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Margaret Beste, BA     617-309-2465     meg.beste@joslin.harvard.edu    
Contact: Florence Brown, MD            
Principal Investigator: Florence M Brown, MD            
Sponsors and Collaborators
Joslin Diabetes Center
Hoffmann-La Roche
  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: September 6, 2012
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 May 21, 2013