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Completed

NCT Number: NCT01613937

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dulce Mother lifestyle training program

Behavioral

12 once weekly culturally tailored lifestyle management sessions

Primary outcomes

  1. HbA1c

    Time frame: 6 months

Secondary outcomes

  1. weight

    Time frame: 6 months

  2. lipids

    Time frame: 6 months

  3. blood pressure

    Time frame: 6 months

  4. composition of dietary intake at all time points

    Time frame: 6 months

  5. hours of physical activity per week at all time points

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Scripps Whittier Diabetes Institute

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Jun 7, 2012
Registry last updated
Nov 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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