Frequency Needed for School-based Obesity Intervention

Obesity, Child Clinical Trial

Official title:

Frequency of Intervention Needed to Improve Weight Outcomes of Mexican-American Adolescents With Overweight or Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03797105
• Other study ID #: STUDY00000487
• Status: Completed
• Phase: N/A
• Start date: August 1, 2012
• Est. completion date: September 30, 2014

Study information

• Verified date: January 2019
• Source: University of Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized controlled trial compared changes in Mexican-American, adolescent standardized body mass index (zBMI) from a school-based obesity intervention given zero, one, three, or five days a week.

Description:

Efficacious school-based interventions have been intensive making it difficult for interventions to be scaled. The more components there are to an intervention, typically the better the results. Instead of decreasing intensity via the removal of intervention components, this randomized controlled trial aimed to compare changes in Mexican-American adolescent standardized body mass index (zBMI) based on the number of days per week they received a multi-component intervention. Mexican-American middle school students (n=203) with overweight or obesity were recruited from an independent school district in Houston. Students were randomized to receive an obesity intervention with established efficacy zero (control), one, three, or five days/week. In each condition, 80% of intervention time was allocated to physical activity and 20% to nutrition. Directly measured height and weight were used to calculate zBMI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: September 30, 2014
• Est. primary completion date: September 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

1. BMI-for-age (Body Mass Index) percentile = 85

2. Male or female between ages 10 - 17 years

3. Self-identified as Mexican-American

Exclusion Criteria:

1. Student who is pregnant, planning to become pregnant, or becomes pregnant

2. School report of cognitive impairment significantly below average age and/or grade level

3. Use of any weight-loss medication (prescription or nonprescription) for at least 6 months prior to screening

4. Type 1 or 2 diabetes medical diagnosis

Related Conditions & MeSH terms

• Obesity
• Obesity, Child
• Pediatric Obesity

Intervention

Behavioral:
• School-Based Obesity Intervention (FLOW)
The intervention consisted of nutrition lessons based on the traffic light diet, circuit-based physical activity, behavior modification techniques (token economy system, goal setting, self-monitoring), and parental involvement (materials sent home and monthly parent meetings). 80% of time was spent on physical activity and 20% was spent on nutrition. Behavior modification was incorporated into both physical activity and nutrition time. Specifically, instruction and activity time during PE class lasted approximately 40 minutes.

Locations

Country	Name	City	State
United States	YES Prep Brays Oaks	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Houston	Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Standardized Body Mass Index (zBMI)	standardized body mass index	baseline, 6, and 12 months