- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03505658
Abriendo Caminos 2: Clearing the Path to Hispanic Health
January 18, 2019 updated by: University of Illinois at Urbana-Champaign
Obesity is significantly higher in specific ethnic groups and, in particular, Hispanics.
There is an urgent need to implement culturally-sensitive lifestyle interventions and educational programs to decrease the burden of obesity and obesity-related metabolic diseases in Hispanic populations.
Accordingly, our overreaching goal is to tailor an existing and successful community-based program, Abriendo Caminos, to leverage effectiveness in promoting healthy nutrition and life-style behaviors among low income, low literacy Hispanic-heritage families.
Our multi-function integrated project proposes to (a) adapt Abriendo Caminos for 6-18 year-old children from Mexican and Puerto Rican heritage in five different locations (California, Illinois, Iowa, Puerto Rico, and Texas) and (b) Train existing professionals (in Extension and community agencies) and future professionals (Hispanic university students) to meet the specific needs of this population.
Our central hypothesis is that participation in a 6-week community-based program will prevent childhood obesity/maintain healthy weight by significantly increasing: (a) healthy dietary behavior patterns and basic knowledge of nutrition; (b) physical activity levels; and (c) the organization of collective/shared family mealtimes.
The implementation of this culturally sensitive, workshop-based curriculum in different regions across the country will help to train the next generation of professionals in Extension and communities to deliver programs that meet the needs of Hispanic families.
The integration of Hispanic college students in program implementation via an experiential learning course will further strengthen the program, as well as increase recruitment and retention of Hispanic students, increasing the capacity of Hispanic communities to meet their own needs in the future.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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San Juan, Puerto Rico
- Recruiting
- University of Puerto Rico
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Contact:
- Maria Plaza, PhD
- Email: maria.plaza@upr.edu
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-
-
-
California
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Fresno, California, United States
- Active, not recruiting
- California State University
-
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Illinois
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Urbana, Illinois, United States, 61801
- Active, not recruiting
- University of Illinois at Urbana-Champaign
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Iowa
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Ames, Iowa, United States, 50011
- Active, not recruiting
- Iowa State University
-
-
Texas
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Houston, Texas, United States
- Recruiting
- University of Houston
-
Contact:
- Norma Olvera, PhD
- Email: NOlvera@Central.UH.EDU
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- a family member being 6-18 years of age
- at least 1 parent being of Hispanic-heritage from Mexican or Puerto Rican origin
Exclusion Criteria:
- no child in the age range of 6-18 years of age
- No parents being of Hispanic-heritage from Mexican or Puerto Rican origin
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
The Intervention is educational with 6 workshops for 2 hrs a week.
Data/ assessments are collected, pre and post the 6 weeks intervention and 6 months post follow-up.
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Involves 6-weeks of education related to healthy behaviors, nutrition, and exercise.
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No Intervention: Control
One or two non-intervention related workshop talks are given; 1 hr each during the same 6 weeks as the intervention arm.
Pre and post assessment/ data collection and 6 months follow-up are completed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BMI
Time Frame: Baseline
|
Body mass index = weight per height square in metrics
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Baseline
|
BMI
Time Frame: 6-month post intervention
|
Body mass index = weight per height square in metrics
|
6-month post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 10, 2015
Primary Completion (Anticipated)
January 1, 2020
Study Completion (Anticipated)
March 31, 2020
Study Registration Dates
First Submitted
February 1, 2018
First Submitted That Met QC Criteria
April 20, 2018
First Posted (Actual)
April 23, 2018
Study Record Updates
Last Update Posted (Actual)
January 22, 2019
Last Update Submitted That Met QC Criteria
January 18, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15503
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
If researchers are interested in obtaining study data please contact the PI for further discussions and what approvals such as IRB is needed to gain access to deidentified data.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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