NCT03505658

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.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable obesity

Geographic Reach
2 countries

5 active sites

Status
unknown

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

April 10, 2015

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 23, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

January 22, 2019

Status Verified

January 1, 2019

Enrollment Period

4.7 years

First QC Date

February 1, 2018

Last Update Submit

January 18, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • BMI

    Body mass index = weight per height square in metrics

    Baseline

  • BMI

    Body mass index = weight per height square in metrics

    6-month post intervention

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Involves 6-weeks of education related to healthy behaviors, nutrition, and exercise.

Intervention

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • a family member being 6-18 years of age
  • at least 1 parent being of Hispanic-heritage from Mexican or Puerto Rican origin

You may not qualify if:

  • no child in the age range of 6-18 years of age
  • No parents being of Hispanic-heritage from Mexican or Puerto Rican origin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

California State University

Fresno, California, United States

ACTIVE NOT RECRUITING

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

ACTIVE NOT RECRUITING

Iowa State University

Ames, Iowa, 50011, United States

ACTIVE NOT RECRUITING

University of Houston

Houston, Texas, United States

RECRUITING

University of Puerto Rico

San Juan, Puerto Rico

RECRUITING

MeSH Terms

Conditions

ObesityPediatric ObesityHealth Education

Interventions

Educational Status

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Central Study Contacts

Margarita Teran-Garcia

CONTACT

Norma Gonzalez

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2018

First Posted

April 23, 2018

Study Start

April 10, 2015

Primary Completion

January 1, 2020

Study Completion

March 31, 2020

Last Updated

January 22, 2019

Record last verified: 2019-01

Locations