Frequency Needed for School-based Obesity Intervention

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Child
• Intervention / Treatment: Behavioral: School-Based Obesity Intervention (FLOW)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 243
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77031
      • YES Prep Brays Oaks

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control, 0 days; control group, no intervention
Experimental: 1 day; received the intervention 1 day/week	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.
Experimental: 3 days; received the intervention 3 days/week	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.
Experimental: 5 days; received the intervention 5 days/week	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Standardized Body Mass Index (zBMI)	standardized body mass index	baseline, 6, and 12 months

Collaborators and Investigators

• Sponsor: University of Houston
• Collaborators: Baylor College of Medicine
• Investigators: Principal Investigator: Craig A Johnston, PhD, University of Houston

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2012
• Primary Completion (Actual): September 30, 2014
• Study Completion (Actual): September 30, 2014

Study Registration Dates

• First Submitted: January 4, 2019
• First Submitted That Met QC Criteria: January 7, 2019
• First Posted (Actual): January 8, 2019

Study Record Updates

• Last Update Posted (Actual): January 8, 2019
• Last Update Submitted That Met QC Criteria: January 7, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: STUDY00000487

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan to make IPD available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No