NCT02344212

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2008

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2015

Completed
Last Updated

January 22, 2015

Status Verified

January 1, 2015

Enrollment Period

3.3 years

First QC Date

January 16, 2015

Last Update Submit

January 21, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in weight

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

    6 months

Study Arms (1)

ESENCIAL Para Vivir

EXPERIMENTAL

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

Interventions

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.

Also known as: ESENCIAL Para Vivir, ESENCIAL: a weight loss program for Latina
ESENCIAL Para Vivir

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Andrea L Cherrington, MD MPH

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2015

First Posted

January 22, 2015

Study Start

February 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

January 22, 2015

Record last verified: 2015-01