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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02344212
• Other study ID #: X080107001
• Status: Completed
• Phase: N/A
• First received: January 16, 2015
• Last updated: January 21, 2015
• Start date: February 2008
• Est. completion date: June 2011

Study information

• Verified date: January 2015
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Robert Wood Johnson Foundation, UAB Diabetes Research Center, UAB Minority Health & Research Center, UAB Nutrition Obesity Research Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight	Change in weight from baseline to end of intervention (6 months)	6 months	No