Weight Loss and Prevention in Latina Immigrants: Advancing Methods of Community-Based Intervention Delivery
January 21, 2015 updated by: University of Alabama at Birmingham
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in weight
Time Frame: 6 months
|
Change in weight from baseline to end of intervention (6 months)
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Andrea L Cherrington, MD MPH, University of Alabama at Birmingham
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
January 16, 2015
First Submitted That Met QC Criteria
January 21, 2015
First Posted (Estimate)
January 22, 2015
Study Record Updates
Last Update Posted (Estimate)
January 22, 2015
Last Update Submitted That Met QC Criteria
January 21, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- X080107001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.