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Clinical Trials/NCT01613937
NCT01613937CompletedNot Applicable

Dulce Mothers: A Community Approach to Reduce the Risks of Developing Diabetes After Gestational Diabetes

Scripps Whittier Diabetes Institute0 sites67 target enrollmentStarted: December 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
67
Primary Endpoint
HbA1c

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •18-45 years old
  • •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

Arms & Interventions

Lifestyle

Experimental

12 once weekly Lifestyle training program

Intervention: Dulce Mother lifestyle training program (Behavioral)

Outcomes

Primary Outcomes

HbA1c

Time Frame: 6 months

Secondary Outcomes

  • lipids(6 months)
  • hours of physical activity per week at all time points(6 months)
  • blood pressure(6 months)
  • weight(6 months)
  • composition of dietary intake at all time points(6 months)

Investigators

Sponsor
Scripps Whittier Diabetes Institute
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Athena Philis-Tsimikas

Primary Investigator

Scripps Whittier Diabetes Institute

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