Clinical/Behavioral Approach to Overweight in Latino Youth

Overweight Clinical Trial

— Luces  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02771951
• Other study ID #: SanDiegoStateU
• Status: Completed
• Phase: N/A
• First received: May 9, 2016
• Last updated: May 12, 2016
• Start date: April 2010
• Est. completion date: March 2016

Study information

• Verified date: May 2016
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 297
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 11 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Overweight
• Pediatric Obesity

Intervention

Behavioral:
• "Lights of Change"

• Usual Care

Locations

Country	Name	City	State
United States	Institute for Behavioral and Community Health at San Diego State University	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index		1 year	Yes