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

This study is ongoing, but not recruiting participants.
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

June 4, 2012
June 5, 2012
December 2009
September 2011   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01613937 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Community Approach to Reduce the Risks of Diabetes After Gestational Diabetes Mellitus
Dulce Mothers: A Community Approach to Reduce the Risks of Developing Diabetes After Gestational Diabetes

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Diabetes
Behavioral: Dulce Mother lifestyle training program
12 once weekly culturally tailored lifestyle management sessions
Experimental: Lifestyle
12 once weekly Lifestyle training program
Intervention: Behavioral: Dulce Mother lifestyle training program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
67
June 2013
September 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01613937
SWDI Dulce Mothers
Yes
Athena Philis-Tsimikas, Scripps Whittier Diabetes Institute
Scripps Whittier Diabetes Institute
Not Provided
Principal Investigator: Athena Philis-Tsimikas, MD Scripps Whittier Diabetes Institute
Scripps Whittier Diabetes Institute
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP