Skip to main content
OpenTrials
Completed

NCT Number: NCT04396769

Family Lifestyle Overweight Prevention Program-Physical Activity Only

This randomized control trial evaluates the physical activity component of the Family Lifestyle Overweight Prevention Program compared to physical education class as usual among Hispanic middle school students.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Family Lifestyle Overweight Prevention Program (FLOW) is an intensive, multi-component obesity intervention designed to take place during physical education class. This intervention has established efficacy at improving standardized BMI among low income, Hispanic middle school students with overweight classification or obesity. However, the efficacy of individual components of the intervention have not been investigated. The purpose of this study was to compare only the physical activity component of FLOW to a physical education class as usual. The primary outcome of the study is time spent in moderate-vigorous physical activity. Secondarily the study evaluated the impact of the intervention on standardized BMI.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age 10-17 years old
  • enrolled in a middle school PE class at YES Prep Brays Oaks

Exclusion criteria

  • pregnant
  • cognitive impairment significantly below average age or grade level

Treatment and study plan

FLOW-PA

Behavioral

Classes were designed to provide the opportunity to be physically activity at a moderate-vigorous level. Each station included exercise options to accommodate varying fitness levels and offer students choice. Heart rate monitors provided consistent biofeedback to students throughout the intervention. Participants were evaluated based on the number of minutes they spent each class between 60-80% of their maximal heart rate. Games were intermixed either as a station or as a break in the circuit (e.g. short game of tag half-way through the workout) to make physical activity enjoyable and engaging.

PE class as usual

Behavioral

PE teachers were instructed to teach class as usual. Research staff were not involved in class activities or instruction. In this school district PE class as usual includes sports-based instruction in which students learn the rules to games and then practice playing.

Primary outcomes

  1. Weekday moderate-vigorous physical activity (MVPA)

    Time frame: six months

    weekday (Monday-Friday) minutes/day of MVPA over time assessed with accelerometry

Secondary outcomes

  1. Weekend moderate-vigorous physical activity (MVPA)

    Time frame: six months

    Weekend (Saturday-Sunday) minutes/day of MVPA over time assessed with accelerometry

  2. standardized BMI (zBMI)

    Time frame: six months

    standardized BMI over time

Sponsors and collaborators

Lead sponsor

University of Houston

Other

Collaborators

  • Baylor College of Medicine

Registry information

Acronym: FLOW-PA

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 21, 2020
Registry last updated
May 22, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.