search
Back to results

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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FLOW-PA
PE class as usual
Sponsored by
University of Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    FLOW-PA

    PE class as usual

    Arm 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.

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

    Outcomes

    Primary Outcome Measures

    Weekday moderate-vigorous physical activity (MVPA)
    weekday (Monday-Friday) minutes/day of MVPA over time assessed with accelerometry

    Secondary Outcome Measures

    Weekend moderate-vigorous physical activity (MVPA)
    Weekend (Saturday-Sunday) minutes/day of MVPA over time assessed with accelerometry
    standardized BMI (zBMI)
    standardized BMI over time

    Full Information

    First Posted
    May 15, 2020
    Last Updated
    May 20, 2020
    Sponsor
    University of Houston
    Collaborators
    Baylor College of Medicine
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04396769
    Brief Title
    Family Lifestyle Overweight Prevention Program-Physical Activity Only
    Acronym
    FLOW-PA
    Official Title
    Family Lifestyle Overweight Prevention Program-Physical Activity Only
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 15, 2011 (Actual)
    Primary Completion Date
    June 1, 2014 (Actual)
    Study Completion Date
    June 1, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Houston
    Collaborators
    Baylor College of Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    491 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    FLOW-PA
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    PE class as usual
    Arm Type
    Active Comparator
    Arm Description
    Participants had PE class as usual 5 days a week for 45 minutes.
    Intervention Type
    Behavioral
    Intervention Name(s)
    FLOW-PA
    Intervention Description
    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
    Intervention Name(s)
    PE class as usual
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Weekday moderate-vigorous physical activity (MVPA)
    Description
    weekday (Monday-Friday) minutes/day of MVPA over time assessed with accelerometry
    Time Frame
    six months
    Secondary Outcome Measure Information:
    Title
    Weekend moderate-vigorous physical activity (MVPA)
    Description
    Weekend (Saturday-Sunday) minutes/day of MVPA over time assessed with accelerometry
    Time Frame
    six months
    Title
    standardized BMI (zBMI)
    Description
    standardized BMI over time
    Time Frame
    six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Craig A Johnston, PhD
    Organizational Affiliation
    University of Houston
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Family Lifestyle Overweight Prevention Program-Physical Activity Only

    We'll reach out to this number within 24 hrs