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

University of Houston

Status: Completed

Conditions: Obesity

Treatments: Behavioral: FLOW-PA; Behavioral: PE class as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT04396769

STUDY00015671

Details and patient eligibility

About

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.

Full 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.

Enrollment: 491 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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491 participants in 2 patient groups

FLOW-PA

Experimental group

Description:

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.

Treatment:

Behavioral: FLOW-PA

PE class as usual

Active Comparator group

Description:

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

Treatment:

Behavioral: PE class as usual