Clinical/Behavioral Approach to Overweight in Latino Youth (Luces)
Primary Purpose
Overweight, Pediatric Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
"Lights of Change"
Usual Care
Sponsored by
About this trial
This is an interventional prevention trial for Overweight focused on measuring Childhood, Obesity
Eligibility Criteria
Inclusion Criteria:
- Self-identify as Latino
- Have made a clinic visit within past 24 months prior to enrollment in study
- Have a BMI % for age/gender between 75 - 99.9th
- Plan on living in target area for following 18 months
- Have transportation to participating clinic
Sites / Locations
- Institute for Behavioral and Community Health at San Diego State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Special Intervention
Usual Care
Arm Description
Study participants randomized to receive Special Intervention receive a series of 7 group classes taught by trained clinic health educators; a series of phone calls; clinical visits with a mid-level provider; and a series of 6 booster group classes over 1 year.
Study participants randomized to receive Usual Care receive up to 2 visits with a usual care health educator over 1 year.
Outcomes
Primary Outcome Measures
Body Mass Index
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02771951
Brief Title
Clinical/Behavioral Approach to Overweight in Latino Youth
Acronym
Luces
Official Title
Clinical/Behavioral Approach to Overweight in Latino Youth: Luces de Cambio
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This randomized controlled trial tests the efficacy of a culturally and linguistically appropriate, evidence-based intervention to slow weight gain or promote weight loss among overweight 6-9 year old Mexican-American children.
Detailed Description
Overweight and obesity is a serious problem for Mexican-American children, due in part to poverty, acculturation, genetic predisposition or other factors. Clinic-based weight control studies have shown promise, but often include convenience samples with few or no Latino children. This randomized controlled trial tests the efficacy of a culturally and linguistically appropriate, evidence-based intervention to lower Body Mass Index (BMI) or slow weight gain among overweight 6-9 year old Mexican-American children randomly sampled from a large (36,192 pediatric patients) community clinic providing services to low and medium income families in a US-Mexico border community (San Ysidro, CA). Intervention and measurement design and selection are based on a "Socioecological Model for Latino Health Promotion". Children and their parents will be randomly assigned to either a Special Intervention (SI) or Usual Care (UC) group. The SI group will participate in the following behavior change activities based on Prevention Plus and Structured Weight Management approaches:
classes providing culturally-sensitive health education regarding healthy eating, increasing physical activity, decreasing sedentary behaviors, and effective parenting behaviors to model and reinforce children's health behaviors, instruction on how to modify both social and structural aspects of the home environment, and skills-building to navigate community resources;
clinical visits with a Health Educator and Mid-Level Provider (MLP);
family visits with primary care providers (PCP); and
phone calls to reinforce goal setting.
The UC group will receive standard health education for childhood obesity already provided by the community clinic. The primary outcome for the study is child BMI, which along with other changes in physical outcomes, child health behaviors and parenting behaviors will be evaluated at four time-points (baseline, 6-, 12-, and 18-months). The primary hypothesis is that the SI group will demonstrate lower mean BMI than the UC group at the end of a 6 month intervention with a maximum difference occurring at 12 months, and will sustain this difference for an additional six months (18 months after baseline). Secondary aims include examining intervention effects on children's energy balance, physical activity levels, sedentary behavior and parenting strategies related to their children's health behaviors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Pediatric Obesity
Keywords
Childhood, Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
297 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Special Intervention
Arm Type
Experimental
Arm Description
Study participants randomized to receive Special Intervention receive a series of 7 group classes taught by trained clinic health educators; a series of phone calls; clinical visits with a mid-level provider; and a series of 6 booster group classes over 1 year.
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm Description
Study participants randomized to receive Usual Care receive up to 2 visits with a usual care health educator over 1 year.
Intervention Type
Behavioral
Intervention Name(s)
"Lights of Change"
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Primary Outcome Measure Information:
Title
Body Mass Index
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Self-identify as Latino
Have made a clinic visit within past 24 months prior to enrollment in study
Have a BMI % for age/gender between 75 - 99.9th
Plan on living in target area for following 18 months
Have transportation to participating clinic
Facility Information:
Facility Name
Institute for Behavioral and Community Health at San Diego State University
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Clinical/Behavioral Approach to Overweight in Latino Youth
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