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
About this trial
This is an interventional prevention trial for Weight Loss
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.
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
NCT ID
NCT02344212
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
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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