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Clinical Trials/NCT04396769
NCT04396769CompletedNot Applicable

Family Lifestyle Overweight Prevention Program-Physical Activity Only

University of Houston0 sites491 target enrollmentStarted: August 15, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
491
Primary Endpoint
Weekday moderate-vigorous physical activity (MVPA)

Study Overview

Brief 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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
10 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •cognitive impairment significantly below average age or grade level

Arms & Interventions

FLOW-PA

Experimental

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.

Intervention: FLOW-PA (Behavioral)

PE class as usual

Active Comparator

Participants had PE class as usual 5 days a week for 45 minutes.

Intervention: PE class as usual (Behavioral)

Outcomes

Primary Outcomes

Weekday moderate-vigorous physical activity (MVPA)

Time Frame: six months

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

Secondary Outcomes

  • Weekend moderate-vigorous physical activity (MVPA)(six months)
  • standardized BMI (zBMI)(six months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Craig A Johnston

Associate Professor

University of Houston

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