Frequency Needed for School-based Obesity Intervention

Not Applicable

Completed

• Conditions: Obesity, Child
• Interventions: Behavioral: School-Based Obesity Intervention (FLOW)

• Registration Number: NCT03797105
• Lead Sponsor: University of Houston

Brief 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.

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 Timeline

• Study Start: 2012-08-01
• Primary Completion: 2014-09-30
• Study Completion: 2014-09-30
• Status Verified: 2019-01
• Study First Submitted: 2019-01-04
• Study First Submitted QC: 2019-01-07
• Last Update Submitted: 2019-01-07
• Study First Posted: 2019-01-08
• Last Update Posted: 2019-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 day	School-Based Obesity Intervention (FLOW)	received the intervention 1 day/week
3 days	School-Based Obesity Intervention (FLOW)	received the intervention 3 days/week
5 days	School-Based Obesity Intervention (FLOW)	received the intervention 5 days/week

Primary Outcome Measures

Name	Time	Method
Change in Standardized Body Mass Index (zBMI)	baseline, 6, and 12 months	standardized body mass index

Trial Locations

Locations (1)

YES Prep Brays Oaks; 🇺🇸 Houston, Texas, United States