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OpenTrials
Completed

NCT Number: NCT02344212

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

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.

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Key information

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ESENCIAL Para Vivir: a weight loss program for Latinas

Behavioral

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

Primary outcomes

  1. Change in weight

    Time frame: 6 months

    Change in weight from baseline to end of intervention (6 months)

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Robert Wood Johnson Foundation
  • UAB Diabetes Research Center
  • UAB Minority Health & Research Center
  • UAB Nutrition Obesity Research Center

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jan 22, 2015
Registry last updated
Jan 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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