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OpenTrials
Completed

NCT Number: NCT03797105

Frequency Needed for School-based Obesity Intervention

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.

Completed

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Key information

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

YES Prep Brays Oaks

Houston, Texas, 77031, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI-for-age (Body Mass Index) percentile ≥ 85
  • Male or female between ages 10 - 17 years
  • Self-identified as Mexican-American

Exclusion criteria

  • Student who is pregnant, planning to become pregnant, or becomes pregnant
  • School report of cognitive impairment significantly below average age and/or grade level
  • Use of any weight-loss medication (prescription or nonprescription) for at least 6 months prior to screening
  • Type 1 or 2 diabetes medical diagnosis

Treatment and study plan

School-Based Obesity Intervention (FLOW)

Behavioral

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.

Primary outcomes

  1. Change in Standardized Body Mass Index (zBMI)

    Time frame: baseline, 6, and 12 months

    standardized body mass index

Sponsors and collaborators

Lead sponsor

University of Houston

Other

Collaborators

  • Baylor College of Medicine

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 8, 2019
Registry last updated
Jan 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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