- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01613937
Community Approach to Reduce the Risks of Diabetes After Gestational Diabetes Mellitus
Dulce Mothers: A Community Approach to Reduce the Risks of Developing Diabetes After Gestational Diabetes
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lifestyle
12 once weekly Lifestyle training program
|
12 once weekly culturally tailored lifestyle management sessions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HbA1c
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
blood pressure
Time Frame: 6 months
|
6 months
|
lipids
Time Frame: 6 months
|
6 months
|
weight
Time Frame: 6 months
|
6 months
|
composition of dietary intake at all time points
Time Frame: 6 months
|
6 months
|
hours of physical activity per week at all time points
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SWDI Dulce Mothers
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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