Family Lifestyle Overweight Prevention Program-Physical Activity Only

Study Overview
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Brief Summary
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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
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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.

Official Title
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Family Lifestyle Overweight Prevention Program-Physical Activity Only

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: FLOW-PA
* Behavioral: PE class as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FLOW-PA<br>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<br>* 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.<br>|
| Active Comparator: PE class as usual<br>Participants had PE class as usual 5 days a week for 45 minutes. | Behavioral: PE class as usual<br>* 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.<br>|

What is the study measuring?
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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 |