Family Lifestyle Overweight Prevention Program-Physical Activity Only

NCT ID: NCT04396769

Last Updated: 2020-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 491 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-15
• Study Completion Date: 2014-06-01

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

FLOW-PA

Intervention Type: BEHAVIORAL

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

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

Group Type: ACTIVE_COMPARATOR

PE class as usual

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: collaborator

University of Houston

OTHER

Sponsor Role: lead

Responsible Party

Craig A Johnston

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Craig A Johnston, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Houston

Other Identifiers

STUDY00015671

Identifier Type: -

Identifier Source: org_study_id