NCT01613937

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Dec 2009

Longer than P75 for not_applicable diabetes

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 7, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

1.8 years

First QC Date

June 4, 2012

Last Update Submit

November 17, 2014

Conditions

Diabetes

Keywords

LatinasGestational DiabetesPrevention

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    6 months

Secondary Outcomes (5)

  • weight

    6 months

  • lipids

    6 months

  • blood pressure

    6 months

  • composition of dietary intake at all time points

    6 months

  • hours of physical activity per week at all time points

    6 months

Study Arms (1)

Lifestyle

EXPERIMENTAL

12 once weekly Lifestyle training program

Behavioral: Dulce Mother lifestyle training program

Interventions

Dulce Mother lifestyle training programBEHAVIORAL

12 once weekly culturally tailored lifestyle management sessions

Lifestyle

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • Latina
  • GDM within the last 3 years
  • able and willing to participate in physical activity sessions

You may not qualify if:

  • current diabetes
  • severe illness that would preclude them from coming to the sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes MellitusDiabetes, Gestational

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Athena Philis-Tsimikas, MD

    Scripps Whittier Diabetes Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

June 4, 2012

First Posted

June 7, 2012

Study Start

December 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2013

Last Updated

November 19, 2014

Record last verified: 2014-11