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

About this trial
This is an interventional prevention trial for Obesity
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
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
NCT ID
NCT04396769
First Posted
May 15, 2020
Last Updated
May 20, 2020
Sponsor
University of Houston
Collaborators
Baylor College of Medicine
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
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