Abriendo Caminos 2: Clearing the Path to Hispanic Health
Primary Purpose
Obesity, Childhood Obesity, Nutrient; Excess
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Education and Behavior
Sponsored by
About this trial
This is an interventional prevention trial for Obesity
Eligibility 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
Sites / Locations
- California State University
- University of Illinois at Urbana-Champaign
- Iowa State University
- University of HoustonRecruiting
- University of Puerto RicoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
BMI
Body mass index = weight per height square in metrics
BMI
Body mass index = weight per height square in metrics
Secondary Outcome Measures
Full Information
NCT ID
NCT03505658
First Posted
February 1, 2018
Last Updated
January 18, 2019
Sponsor
University of Illinois at Urbana-Champaign
Collaborators
California State University, Fresno Foundation, Iowa State University, University of Houston, University of Puerto Rico
1. Study Identification
Unique Protocol Identification Number
NCT03505658
Brief Title
Abriendo Caminos 2: Clearing the Path to Hispanic Health
Official Title
Abriendo Caminos 2: Clearing the Path to Hispanic Health
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 10, 2015 (Actual)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
March 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Illinois at Urbana-Champaign
Collaborators
California State University, Fresno Foundation, Iowa State University, University of Houston, University of Puerto Rico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood Obesity, Nutrient; Excess, Community Health Education
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education and Behavior
Intervention Description
Involves 6-weeks of education related to healthy behaviors, nutrition, and exercise.
Primary Outcome Measure Information:
Title
BMI
Description
Body mass index = weight per height square in metrics
Time Frame
Baseline
Title
BMI
Description
Body mass index = weight per height square in metrics
Time Frame
6-month post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margarita Teran-Garcia
Phone
217-244-2025
Email
teranmd@illinois.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Norma Gonzalez
Phone
217-300-4924
Email
normag@illinois.edu
Facility Information:
Facility Name
California State University
City
Fresno
State/Province
California
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Illinois at Urbana-Champaign
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Iowa State University
City
Ames
State/Province
Iowa
ZIP/Postal Code
50011
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Houston
City
Houston
State/Province
Texas
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norma Olvera, PhD
Email
NOlvera@Central.UH.EDU
Facility Name
University of Puerto Rico
City
San Juan
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Plaza, PhD
Email
maria.plaza@upr.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing 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.
Learn more about this trial
Abriendo Caminos 2: Clearing the Path to Hispanic Health
We'll reach out to this number within 24 hrs