Family Lifestyle Overweight Prevention Program-Physical Activity Only

Obesity Clinical Trial

— FLOW-PA  

Official title:

Family Lifestyle Overweight Prevention Program-Physical Activity Only

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04396769
• Other study ID #: STUDY00015671
• Status: Completed
• Phase: N/A
• Start date: August 15, 2011
• Est. completion date: June 1, 2014

Study information

• Verified date: May 2020
• Source: University of Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 491
• Est. completion date: June 1, 2014
• Est. primary completion date: June 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• FLOW-PA
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Houston	Baylor College of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weekday moderate-vigorous physical activity (MVPA)	weekday (Monday-Friday) minutes/day of MVPA over time assessed with accelerometry	six months
Secondary	Weekend moderate-vigorous physical activity (MVPA)	Weekend (Saturday-Sunday) minutes/day of MVPA over time assessed with accelerometry	six months
Secondary	standardized BMI (zBMI)	standardized BMI over time	six months