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Abriendo Caminos 2: Clearing the Path to Hispanic Health

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03505658
Recruitment Status : Unknown
Verified January 2019 by University of Illinois at Urbana-Champaign.
Recruitment status was:  Recruiting
First Posted : April 23, 2018
Last Update Posted : January 22, 2019
Sponsor:
Collaborators:
California State University, Fresno Foundation
Iowa State University
University of Houston
University of Puerto Rico
Information provided by (Responsible Party):
University of Illinois at Urbana-Champaign

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Childhood Obesity Nutrient; Excess Community Health Education Behavioral: Education and Behavior Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Abriendo Caminos 2: Clearing the Path to Hispanic Health
Actual Study Start Date : April 10, 2015
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : March 31, 2020
Arms and Interventions
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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.
 Behavioral: Education and Behavior
Involves 6-weeks of education related to healthy behaviors, nutrition, and exercise.
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.


Outcome Measures
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Primary Outcome Measures :
  1. BMI [ Time Frame: Baseline ]
    Body mass index = weight per height square in metrics

  2. BMI [ Time Frame: 6-month post intervention ]
    Body mass index = weight per height square in metrics


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505658


Contacts
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Contact: Margarita Teran-Garcia 217-244-2025 teranmd@illinois.edu
Contact: Norma Gonzalez 217-300-4924 normag@illinois.edu

Locations
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United States, California
California State University Active, not recruiting
Fresno, California, United States
United States, Illinois
University of Illinois at Urbana-Champaign Active, not recruiting
Urbana, Illinois, United States, 61801
United States, Iowa
Iowa State University Active, not recruiting
Ames, Iowa, United States, 50011
United States, Texas
University of Houston Recruiting
Houston, Texas, United States
Contact: Norma Olvera, PhD       NOlvera@Central.UH.EDU   
Puerto Rico
University of Puerto Rico Recruiting
San Juan, Puerto Rico
Contact: Maria Plaza, PhD       maria.plaza@upr.edu   
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
California State University, Fresno Foundation
Iowa State University
University of Houston
University of Puerto Rico
  Study Documents (Full-Text)

Documents provided by University of Illinois at Urbana-Champaign:
Statistical Analysis Plan  [PDF] April 6, 2018
Study Protocol  [PDF] April 6, 2018

More Information
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Additional Information:

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Responsible Party: University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT03505658    
Other Study ID Numbers: 15503
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: January 22, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
 Nutrition Disorders
Overweight
Body Weight