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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01613937
• Other study ID #: SWDI Dulce Mothers
• Status: Completed
• Phase: N/A
• First received: June 4, 2012
• Last updated: November 17, 2014
• Start date: December 2009
• Est. completion date: September 2013

Study information

• Verified date: November 2014
• Source: Scripps Whittier Diabetes Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: September 2013
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes, Gestational

Intervention

Behavioral:
• Dulce Mother lifestyle training program
12 once weekly culturally tailored lifestyle management sessions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Scripps Whittier Diabetes Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		6 months	No
Secondary	weight		6 months	No
Secondary	lipids		6 months	No
Secondary	blood pressure		6 months	No
Secondary	composition of dietary intake at all time points		6 months	No
Secondary	hours of physical activity per week at all time points		6 months	No