Clinical/Behavioral Approach to Overweight in Latino Youth

NCT ID: NCT02771951

Last Updated: 2016-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 297 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2016-03-31

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.

Conditions

Overweight; Pediatric Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Special Intervention

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.

Group Type: EXPERIMENTAL

"Lights of Change"

Intervention Type: BEHAVIORAL

Usual Care

Study participants randomized to receive Usual Care receive up to 2 visits with a usual care health educator over 1 year.

Group Type: PLACEBO_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

Interventions

"Lights of Change"

Intervention Type: BEHAVIORAL

Usual Care

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

San Diego State University

OTHER

Sponsor Role: lead

Responsible Party

John Elder

Distinguished Professor of Public Health; and Adjunct Professor of Family and Precentive Medicine, UCSD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institute for Behavioral and Community Health at San Diego State University

San Diego, California, United States

Countries

United States

Other Identifiers

SanDiegoStateU

Identifier Type: -

Identifier Source: org_study_id