Frequency Needed for School-based Obesity Intervention
Frequency of Intervention Needed to Improve Weight Outcomes of Mexican-American Adolescents With Overweight or Obesity
1 other identifier
interventional
243
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2012
Typical duration for not_applicable
1 active site
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 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2014
CompletedFirst Submitted
Initial submission to the registry
January 4, 2019
CompletedFirst Posted
Study publicly available on registry
January 8, 2019
CompletedJanuary 8, 2019
January 1, 2019
2.2 years
January 4, 2019
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 INTERVENTIONcontrol group, no intervention
1 day
EXPERIMENTALreceived the intervention 1 day/week
3 days
EXPERIMENTALreceived the intervention 3 days/week
5 days
EXPERIMENTALreceived the intervention 5 days/week
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.
Eligibility Criteria
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
- University of Houstonlead
- Baylor College of Medicinecollaborator
Study Sites (1)
YES Prep Brays Oaks
Houston, Texas, 77031, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Craig A Johnston, PhD
University of Houston
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