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

Primary Purpose

Diabetes

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dulce Mother lifestyle training program
Sponsored by
Scripps Whittier Diabetes Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes focused on measuring Latinas, Gestational Diabetes, Prevention

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Lifestyle

    Arm Description

    12 once weekly Lifestyle training program

    Outcomes

    Primary Outcome Measures

    HbA1c

    Secondary Outcome Measures

    weight
    lipids
    blood pressure
    composition of dietary intake at all time points
    hours of physical activity per week at all time points

    Full Information

    First Posted
    June 4, 2012
    Last Updated
    November 17, 2014
    Sponsor
    Scripps Whittier Diabetes Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01613937
    Brief Title
    Community Approach to Reduce the Risks of Diabetes After Gestational Diabetes Mellitus
    Official Title
    Dulce Mothers: A Community Approach to Reduce the Risks of Developing Diabetes After Gestational Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2009 (undefined)
    Primary Completion Date
    September 2011 (Actual)
    Study Completion Date
    September 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Scripps Whittier Diabetes Institute

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes
    Keywords
    Latinas, Gestational Diabetes, Prevention

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    67 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lifestyle
    Arm Type
    Experimental
    Arm Description
    12 once weekly Lifestyle training program
    Intervention Type
    Behavioral
    Intervention Name(s)
    Dulce Mother lifestyle training program
    Intervention Description
    12 once weekly culturally tailored lifestyle management sessions
    Primary Outcome Measure Information:
    Title
    HbA1c
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    weight
    Time Frame
    6 months
    Title
    lipids
    Time Frame
    6 months
    Title
    blood pressure
    Time Frame
    6 months
    Title
    composition of dietary intake at all time points
    Time Frame
    6 months
    Title
    hours of physical activity per week at all time points
    Time Frame
    6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Athena Philis-Tsimikas, MD
    Organizational Affiliation
    Scripps Whittier Diabetes Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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