Clinical trial NCT02344212: 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
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: UAB Diabetes Research Center
name: UAB Nutrition Obesity Research Center
name: UAB Minority Health & Research Center
name: Robert Wood Johnson Foundation
First posted: 2015-01-22
Enrollment: 35
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change in weight
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Andrea L Cherrington, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.