NCT04396769

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
491

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
Last Updated

May 22, 2020

Status Verified

May 1, 2020

Enrollment Period

2.8 years

First QC Date

May 15, 2020

Last Update Submit

May 20, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Weekday moderate-vigorous physical activity (MVPA)

    weekday (Monday-Friday) minutes/day of MVPA over time assessed with accelerometry

    six months

Secondary Outcomes (2)

  • Weekend moderate-vigorous physical activity (MVPA)

    six months

  • standardized BMI (zBMI)

    six months

Study Arms (2)

FLOW-PA

EXPERIMENTAL

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

PE class as usual

ACTIVE COMPARATOR

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

Behavioral: PE class as usual

Interventions

FLOW-PABEHAVIORAL

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.

FLOW-PA

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.

PE class as usual

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • age 10-17 years old
  • enrolled in a middle school PE class at YES Prep Brays Oaks

You may not qualify if:

  • pregnant
  • cognitive impairment significantly below average age or grade level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Craig A Johnston, PhD

    University of Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 15, 2020

First Posted

May 21, 2020

Study Start

August 15, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

May 22, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share