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Frequency Needed for School-based Obesity Intervention

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University of Houston

Status

Completed

Conditions

Obesity, Child

Treatments

Behavioral: School-Based Obesity Intervention (FLOW)

Study type

Interventional

Funder types

Other

Identifiers

NCT03797105
STUDY00000487

Details and patient eligibility

About

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.

Full description

Efficacious school-based interventions have been intensive making it difficult for interventions to be scaled. The more components there are to an intervention, typically the better the results. Instead of decreasing intensity via the removal of intervention components, this randomized controlled trial aimed to compare changes in Mexican-American adolescent standardized body mass index (zBMI) based on the number of days per week they received a multi-component intervention. Mexican-American middle school students (n=203) with overweight or obesity were recruited from an independent school district in Houston. Students were randomized to receive an obesity intervention with established efficacy zero (control), one, three, or five days/week. In each condition, 80% of intervention time was allocated to physical activity and 20% to nutrition. Directly measured height and weight were used to calculate zBMI.

Enrollment

243 patients

Sex

All

Ages

10 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

243 participants in 4 patient groups

Control, 0 days
No Intervention group
Description:
control group, no intervention
1 day
Experimental group
Description:
received the intervention 1 day/week
Treatment:
Behavioral: School-Based Obesity Intervention (FLOW)
3 days
Experimental group
Description:
received the intervention 3 days/week
Treatment:
Behavioral: School-Based Obesity Intervention (FLOW)
5 days
Experimental group
Description:
received the intervention 5 days/week
Treatment:
Behavioral: School-Based Obesity Intervention (FLOW)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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