We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02344212
Recruitment Status : Completed
First Posted : January 22, 2015
Last Update Posted : January 22, 2015
Sponsor:
Collaborators:
UAB Diabetes Research Center
UAB Nutrition Obesity Research Center
UAB Minority Health & Research Center
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
University of Alabama at Birmingham

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Weight Loss Behavioral: ESENCIAL Para Vivir: a weight loss program for Latinas Not Applicable

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Weight Loss and Prevention in Latina Immigrants: Advancing Methods of Community-Based Intervention Delivery
Study Start Date : February 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: ESENCIAL Para Vivir
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.
 Behavioral: ESENCIAL Para Vivir: a weight loss program for Latinas
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.
Other Names:
  • ESENCIAL Para Vivir
  • ESENCIAL: a weight loss program for Latina


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in weight [ Time Frame: 6 months ]
    Change in weight from baseline to end of intervention (6 months)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02344212


Sponsors and Collaborators
University of Alabama at Birmingham
UAB Diabetes Research Center
UAB Nutrition Obesity Research Center
UAB Minority Health & Research Center
Robert Wood Johnson Foundation
Investigators
Layout table for investigator information
Principal Investigator: Andrea L Cherrington, MD MPH University of Alabama at Birmingham
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02344212    
Other Study ID Numbers: X080107001
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: January 22, 2015
Last Verified: January 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Body Weight
Weight Loss
Body Weight Changes