Community Approach to Reduce the Risks of Diabetes After... | NCT01613937

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

NCT01613937

Sponsor

Scripps Whittier Diabetes Institute

Status

Completed

Last Update Posted

Nov 19, 2014Estimated

Enrollment

67Actual

Phase

Not Applicable

Conditions

Diabetes

Interventions

Dulce Mother lifestyle training program

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2013Actual

First Submitted Date

Jun 4, 2012

First Submission Date that Met QC Criteria

Jun 5, 2012

First Posted Date

Jun 7, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2014

Last Update Posted Date

Nov 19, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Athena Philis-Tsimikas, Primary Investigator, Scripps Whittier Diabetes InstitutePrincipal Investigator

Lead Sponsor

Scripps Whittier Diabetes InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lifestyle	Experimental	12 once weekly Lifestyle training program	Behavioral: Dulce Mother lifestyle training program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dulce Mother lifestyle training program	Behavioral	12 once weekly culturally tailored lifestyle management sessions	Lifestyle

Measure	Description	Time Frame
HbA1c		6 months

Measure	Description	Time Frame
weight		6 months
lipids		6 months
blood pressure

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Athena Philis-Tsimikas, MD	Scripps Whittier Diabetes Institute	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D016640	Diabetes, Gestational

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided