ObesityNCT03505658
Abriendo Caminos 2: Clearing the Path to Hispanic Health
A study testing Education and Behavior in people with Obesity and Childhood Obesity, run by University of Illinois at Urbana-Champaign at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood Obesity, Nutrient; Excess
- What is being tested?
- Education and Behavior
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 10 Apr 2015to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- a family member being 6-18 years of age
- at least 1 parent being of Hispanic-heritage from Mexican or Puerto Rican origin
Who cannot join
- no child in the age range of 6-18 years of age
- No parents being of Hispanic-heritage from Mexican or Puerto Rican origin
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites, 1 recruiting
- Active, not recruiting
Iowa State University
Ames, Iowa, 50011
- Active, not recruiting
California State University
Fresno, California
- Recruiting
University of Houston
Houston, Texas
Norma Olvera, PhD, NOlvera@Central.UH.EDU
- Active, not recruiting
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
Puerto Rico1 site, 1 recruiting
- Recruiting
University of Puerto Rico
San Juan
Maria Plaza, PhD, maria.plaza@upr.edu
About this study
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.
- Being tested
- Education and Behavior
- Medical subject headings
- Obesity, Pediatric Obesity, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and BehaviorBehavioural
Involves 6-weeks of education related to healthy behaviors, nutrition, and exercise.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Body mass index = weight per height square in metrics
Measured: Baseline
BMI
Body mass index = weight per height square in metrics
Measured: 6-month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start10 Apr 2015
- Primary completion1 Jan 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- California State University, Fresno Foundation, Iowa State University, University of Houston, University of Puerto Rico
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505658
- Sponsor's protocol ID
- 15503
- Status last verified
- Jan 2019
- First submitted
- 1 Feb 2018
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abriendo Caminos 2: Clearing the Path to Hispanic Health
- ClinicalTrials.gov ID
- NCT03505658
- Acronym / sponsor ID
- 15503
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- California State University, Fresno Foundation, Iowa State University, University of Houston, University of Puerto Rico
- Study start
- 10 Apr 2015 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 23 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Education and BehaviorThe 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. |
| 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- a family member being 6-18 years of age
- at least 1 parent being of Hispanic-heritage from Mexican or Puerto Rican origin
Key exclusion criteria (2 listed)
- no child in the age range of 6-18 years of age
- No parents being of Hispanic-heritage from Mexican or Puerto Rican origin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education and BehaviorInvolves 6-weeks of education related to healthy behaviors, nutrition, and exercise. | Behavioural | Intervention |
Primary outcome
BMI
Time frame: Baseline
Body mass index = weight per height square in metrics
BMI
Time frame: 6-month post intervention
Body mass index = weight per height square in metrics
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Behavior in people with Obesity and Childhood Obesity, run by University of Illinois at Urbana-Champaign at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Margarita Teran-Garcia (217-244-2025, teranmd@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2019.