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

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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

Tracking Information
First Submitted Date  ICMJE January 16, 2015
First Posted Date  ICMJE January 22, 2015
Last Update Posted Date January 22, 2015
Study Start Date  ICMJE February 2008
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2015)		 Change in weight [ Time Frame: 6 months ]
Change in weight from baseline to end of intervention (6 months)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Weight Loss and Prevention in Latina Immigrants: Advancing Methods of Community-Based Intervention Delivery
Official Title  ICMJE Weight Loss and Prevention in Latina Immigrants: Advancing Methods of Community-Based Intervention Delivery
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Weight Loss
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Behavioral: ESENCIAL Para Vivir: a weight loss program for Latinas
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 21, 2015)		 35
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02344212
Other Study ID Numbers  ICMJE X080107001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Alabama at Birmingham
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Alabama at Birmingham
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • UAB Diabetes Research Center
  • UAB Nutrition Obesity Research Center
  • UAB Minority Health & Research Center
  • Robert Wood Johnson Foundation
Investigators  ICMJE
Principal Investigator: Andrea L Cherrington, MD MPH University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP