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Clinical/Behavioral Approach to Overweight in Latino Youth

Clinical/Behavioral Approach to Overweight in Latino Youth: Luces de Cambio

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02771951
Acronym
Luces
Enrollment
297
Registered
2016-05-13
Start date
2010-04-30
Completion date
2016-03-31
Last updated
2016-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight, Pediatric Obesity

Keywords

Childhood, Obesity

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: 1. 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; 2. clinical visits with a Health Educator and Mid-Level Provider (MLP); 3. family visits with primary care providers (PCP); and 4. 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.

Interventions

BEHAVIORALLights of Change
BEHAVIORALUsual Care

Sponsors

San Diego State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Body Mass Index1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026