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
  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
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 April 16, 2014