NCT03797105

Brief Summary

This randomized controlled trial compared changes in Mexican-American, adolescent standardized body mass index (zBMI) from a school-based obesity intervention given zero, one, three, or five days a week.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
243

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2014

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 8, 2019

Completed
Last Updated

January 8, 2019

Status Verified

January 1, 2019

Enrollment Period

2.2 years

First QC Date

January 4, 2019

Last Update Submit

January 7, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Standardized Body Mass Index (zBMI)

    standardized body mass index

    baseline, 6, and 12 months

Study Arms (4)

Control, 0 days

NO INTERVENTION

control group, no intervention

1 day

EXPERIMENTAL

received the intervention 1 day/week

Behavioral: School-Based Obesity Intervention (FLOW)

3 days

EXPERIMENTAL

received the intervention 3 days/week

Behavioral: School-Based Obesity Intervention (FLOW)

5 days

EXPERIMENTAL

received the intervention 5 days/week

Behavioral: School-Based Obesity Intervention (FLOW)

Interventions

The intervention consisted of nutrition lessons based on the traffic light diet, circuit-based physical activity, behavior modification techniques (token economy system, goal setting, self-monitoring), and parental involvement (materials sent home and monthly parent meetings). 80% of time was spent on physical activity and 20% was spent on nutrition. Behavior modification was incorporated into both physical activity and nutrition time. Specifically, instruction and activity time during PE class lasted approximately 40 minutes.

1 day3 days5 days

Eligibility Criteria

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

You may qualify if:

  • BMI-for-age (Body Mass Index) percentile ≥ 85
  • Male or female between ages 10 - 17 years
  • Self-identified as Mexican-American

You may not qualify if:

  • Student who is pregnant, planning to become pregnant, or becomes pregnant
  • School report of cognitive impairment significantly below average age and/or grade level
  • Use of any weight-loss medication (prescription or nonprescription) for at least 6 months prior to screening
  • Type 1 or 2 diabetes medical diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

YES Prep Brays Oaks

Houston, Texas, 77031, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition 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
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 4, 2019

First Posted

January 8, 2019

Study Start

August 1, 2012

Primary Completion

September 30, 2014

Study Completion

September 30, 2014

Last Updated

January 8, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

There is no plan to make IPD available to other researchers

Locations