Frequency Needed for School-based Obesity Intervention

NCT ID: NCT03797105

Last Updated: 2019-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 243 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-01
• Study Completion Date: 2014-09-30

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.

Detailed 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.

Conditions

Obesity, Child

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control, 0 days

control group, no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

1 day

received the intervention 1 day/week

Group Type: EXPERIMENTAL

School-Based Obesity Intervention (FLOW)

Intervention Type: BEHAVIORAL

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.

3 days

received the intervention 3 days/week

Group Type: EXPERIMENTAL

School-Based Obesity Intervention (FLOW)

Intervention Type: BEHAVIORAL

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.

5 days

received the intervention 5 days/week

Group Type: EXPERIMENTAL

School-Based Obesity Intervention (FLOW)

Intervention Type: BEHAVIORAL

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.

Interventions

School-Based Obesity Intervention (FLOW)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: collaborator

University of Houston

OTHER

Sponsor Role: lead

Responsible Party

Craig A Johnston

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Craig A Johnston, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Houston

Locations

YES Prep Brays Oaks

Houston, Texas, United States

Countries

United States

Other Identifiers

STUDY00000487

Identifier Type: -

Identifier Source: org_study_id