Family Lifestyle Overweight Prevention Program-Physical Activity Only (FLOW-PA)

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: FLOW-PA; Behavioral: PE class as usual

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 491
• Phase: Not Applicable

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:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FLOW-PA; Participants received the physical activity component of FLOW five days a week during participants' 45-minute long physical education (PE) class period for six months. Intervention activities were designed to promote moderate-vigorous physical activity through circuit-based stations with both aerobic and strength exercises. Trained research staff partnered with PE teachers to facilitate lessons and undergraduate college students were trained to complete activities with participants.	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.
Active Comparator: PE class as usual; Participants had PE class as usual 5 days a week for 45 minutes.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weekday moderate-vigorous physical activity (MVPA)	weekday (Monday-Friday) minutes/day of MVPA over time assessed with accelerometry	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weekend moderate-vigorous physical activity (MVPA)	Weekend (Saturday-Sunday) minutes/day of MVPA over time assessed with accelerometry	six months
standardized BMI (zBMI)	standardized BMI over time	six 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 15, 2011
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 15, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): May 22, 2020
• Last Update Submitted That Met QC Criteria: May 20, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: STUDY00015671

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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