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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Weight Loss

Intervention / Treatment
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* Behavioral: ESENCIAL Para Vivir: a weight loss program for Latinas


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESENCIAL Para Vivir<br>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<br>* 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.<br>* Other names: ESENCIAL: a weight loss program for Latina;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight | Change in weight from baseline to end of intervention (6 months) | 6 months |