Community Approach to Reduce the Risks of Diabetes After Gestational Diabetes Mellitus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Scripps Whittier Diabetes Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Athena Philis-Tsimikas, Scripps Whittier Diabetes Institute
ClinicalTrials.gov Identifier:
NCT01613937
First received: June 4, 2012
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

Objective: The current study examined the effectiveness of a culturally-appropriate adaptation of the diabetes prevention program (DPP) curriculum in reducing type 2 diabetes risk in Latinas with a history of gestational diabetes mellitus (GDM).

Research Design and Methods: Seventy-six Latinas aged 18-45 years with GDM in the past 3 years participated in an 8-week group-based, peer-educator led lifestyle intervention based on the DPP, with adaptations appropriate to Latino culture and recent mothers. Clinical and self-report indicators were assessed at baseline, post-intervention (month-3), and follow-up (month-6).

Hypothesis-The modified culturally tailored DPP will improve risk factors associated with the development of type 2 DM.


Condition Intervention
Diabetes
Behavioral: Dulce Mother lifestyle training program

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Dulce Mothers: A Community Approach to Reduce the Risks of Developing Diabetes After Gestational Diabetes

Resource links provided by NLM:


Further study details as provided by Scripps Whittier Diabetes Institute:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • lipids [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • composition of dietary intake at all time points [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • hours of physical activity per week at all time points [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: December 2009
Estimated Study Completion Date: June 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle
12 once weekly Lifestyle training program
Behavioral: Dulce Mother lifestyle training program
12 once weekly culturally tailored lifestyle management sessions

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-45 years old
  • Latina
  • GDM within the last 3 years
  • able and willing to participate in physical activity sessions

Exclusion Criteria:

  • current diabetes
  • severe illness that would preclude them from coming to the sessions
  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: NCT01613937

Sponsors and Collaborators
Scripps Whittier Diabetes Institute
Investigators
Principal Investigator: Athena Philis-Tsimikas, MD Scripps Whittier Diabetes Institute
  More Information

No publications provided

Responsible Party: Athena Philis-Tsimikas, Primary Investigator, Scripps Whittier Diabetes Institute
ClinicalTrials.gov Identifier: NCT01613937     History of Changes
Other Study ID Numbers: SWDI Dulce Mothers
Study First Received: June 4, 2012
Last Updated: June 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Scripps Whittier Diabetes Institute:
Latinas
Gestational Diabetes
Prevention

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on July 28, 2014