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Weight Loss and Prevention in Latina Immigrants: Advancing Methods of Community-Based Intervention Delivery

Primary Purpose

Weight Loss

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ESENCIAL Para Vivir: a weight loss program for Latinas
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Weight Loss

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • female aged 19 years or older,
  • foreign born, self-identified as Latina,
  • no history of diagnosed diabetes,
  • fasting blood sugar < 126 mg/dL, and overweight or obese (BMI > 25kg/m2).

Exclusion Criteria:

  • any medical condition for which weight loss was contraindicated; a fasting glucose > 126 mg/dL,
  • pregnancy, postpartum less than 6 months, or planning a pregnancy before the end of the study period.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    ESENCIAL Para Vivir

    Arm Description

    Overweight or obese Latina immigrant women were recruited to participate an 8-week weight loss program to reduce or delay their risk of developing diabetes. Data was collected at baseline, program completion, and six months.

    Outcomes

    Primary Outcome Measures

    Change in weight
    Change in weight from baseline to end of intervention (6 months)

    Secondary Outcome Measures

    Full Information

    First Posted
    January 16, 2015
    Last Updated
    January 21, 2015
    Sponsor
    University of Alabama at Birmingham
    Collaborators
    UAB Diabetes Research Center, UAB Nutrition Obesity Research Center, UAB Minority Health & Research Center, Robert Wood Johnson Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02344212
    Brief Title
    Weight Loss and Prevention in Latina Immigrants: Advancing Methods of Community-Based Intervention Delivery
    Official Title
    Weight Loss and Prevention in Latina Immigrants: Advancing Methods of Community-Based Intervention Delivery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2008 (undefined)
    Primary Completion Date
    June 2011 (Actual)
    Study Completion Date
    June 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Alabama at Birmingham
    Collaborators
    UAB Diabetes Research Center, UAB Nutrition Obesity Research Center, UAB Minority Health & Research Center, Robert Wood Johnson Foundation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The long-term objective of this study protocol is to develop and test a culturally sensitive, community-based intervention, ESENCIAL Para Vivir (Essential for Life) to promote weight loss and diabetes prevention among overweight or obese Latina immigrants. We chose to focus on Latinas because Latinas are at especially high risk for developing diabetes and currently there are not Spanish programs available in our area that provide education about weight management and diabetes prevention.
    Detailed Description
    The 8-week weight loss program, ESENCIAL Para Vivir (Essential for Life), is comprised of 6 groups sessions and 2 individual sessions delivered by a bilingiual, bi-cultural Community Health Advisor. All sessions are interactive with activities that build on educative content and most contain an interactive DVD component. We propose an innovative approach that will employ the DVD in tandem with our education sessions delivered by a Community Health Advisor to maximize buy-in from participants as well as provide access to community health leaders (medical professionals - endocrinologists, internists, nutritionists). Participants will be over 19 years of age, self-identifying as Hispanic women without diabetes, not pregnant or have given birth within the previous six months. The participants will be recruited from Jefferson County through community agencies and organization. Participants will be recruited and screened with an initial contact sheet to ensure that they meet our criteria, then they will be consented and complete baseline measurements. At the completion of the program, participants will repeat measures done at baseline, and 6 months post program completion.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Weight Loss

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    35 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ESENCIAL Para Vivir
    Arm Type
    Experimental
    Arm Description
    Overweight or obese Latina immigrant women were recruited to participate an 8-week weight loss program to reduce or delay their risk of developing diabetes. Data was collected at baseline, program completion, and six months.
    Intervention Type
    Behavioral
    Intervention Name(s)
    ESENCIAL Para Vivir: a weight loss program for Latinas
    Other Intervention Name(s)
    ESENCIAL Para Vivir, ESENCIAL: a weight loss program for Latina
    Intervention Description
    Overweight or obese Latina immigrant women were recruited to participate an 8-week weight loss program to reduce or delay their risk of developing diabetes. Data was collected at baseline, program completion, and six months.
    Primary Outcome Measure Information:
    Title
    Change in weight
    Description
    Change in weight from baseline to end of intervention (6 months)
    Time Frame
    6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: female aged 19 years or older, foreign born, self-identified as Latina, no history of diagnosed diabetes, fasting blood sugar < 126 mg/dL, and overweight or obese (BMI > 25kg/m2). Exclusion Criteria: any medical condition for which weight loss was contraindicated; a fasting glucose > 126 mg/dL, pregnancy, postpartum less than 6 months, or planning a pregnancy before the end of the study period.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andrea L Cherrington, MD MPH
    Organizational Affiliation
    University of Alabama at Birmingham
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26217532
    Citation
    Cherrington AL, Willig AL, Agne AA, Fowler MC, Dutton GR, Scarinci IC. Development of a theory-based, peer support intervention to promote weight loss among Latina immigrants. BMC Obes. 2015 Mar 19;2:17. doi: 10.1186/s40608-015-0047-3. eCollection 2015.
    Results Reference
    derived

    Learn more about this trial

    Weight Loss and Prevention in Latina Immigrants: Advancing Methods of Community-Based Intervention Delivery

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