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

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ClinicalTrials.gov Identifier: NCT01613937
Recruitment Status : Completed
First Posted : June 7, 2012
Last Update Posted : November 19, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Diabetes Behavioral: Dulce Mother lifestyle training program

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Dulce Mothers: A Community Approach to Reduce the Risks of Developing Diabetes After Gestational Diabetes
Study Start Date : December 2009
Primary Completion Date : September 2011
Study Completion Date : September 2013
Arms and Interventions

Arm Intervention/treatment
Experimental: Lifestyle
12 once weekly Lifestyle training program
Behavioral: Dulce Mother lifestyle training program
12 once weekly culturally tailored lifestyle management sessions

Outcome Measures

Primary Outcome Measures :
  1. HbA1c [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. weight [ Time Frame: 6 months ]
  2. lipids [ Time Frame: 6 months ]
  3. blood pressure [ Time Frame: 6 months ]
  4. composition of dietary intake at all time points [ Time Frame: 6 months ]
  5. hours of physical activity per week at all time points [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01613937

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

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
First Posted: June 7, 2012    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014

Keywords provided by Athena Philis-Tsimikas, Scripps Whittier Diabetes Institute:
Gestational Diabetes

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