Obesity, ChildNCT03797105
Frequency Needed for School-based Obesity Intervention
A study testing School-Based Obesity Intervention (FLOW) in people with Obesity, Child, run by University of Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Obesity, Child
- What is being tested?
- School-Based Obesity Intervention (FLOW)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2012to 30 Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- BMI-for-age (Body Mass Index) percentile ≥ 85
- Male or female between ages 10 - 17 years
- Self-identified as Mexican-American
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frequency of Intervention Needed to Improve Weight Outcomes of Mexican-American Adolescents With Overweight or Obesity
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.
Read the 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
- Being tested
- School-Based Obesity Intervention (FLOW)
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School-Based Obesity Intervention (FLOW)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control, 0 days | No intervention | control group, no intervention |
| 1 day | Experimental | received the intervention 1 day/week Receives: Behavioral: School-Based Obesity Intervention (FLOW) |
| 3 days | Experimental | received the intervention 3 days/week Receives: Behavioral: School-Based Obesity Intervention (FLOW) |
| 5 days | Experimental | received the intervention 5 days/week Receives: Behavioral: School-Based Obesity Intervention (FLOW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Standardized Body Mass Index (zBMI)
standardized body mass index
Measured: baseline, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start1 Aug 2012
- Primary completion30 Sep 2014
- Study completion30 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine
- Responsible party
- Principal investigator, Craig A Johnston, University of Houston
- Investigators
- Craig A Johnston, PhD, Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797105
- Sponsor's protocol ID
- STUDY00000487
- Status last verified
- Jan 2019
- First submitted
- 4 Jan 2019
- Last updated
- 8 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Intervention Needed to Improve Weight Outcomes of Mexican-American Adolescents With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT03797105
- Acronym / sponsor ID
- STUDY00000487
- Conditions
- Obesity, Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- Baylor College of Medicine
- Study start
- 1 Aug 2012 (actual)
- Primary completion
- 30 Sep 2014 (actual)
- Study completion
- 30 Sep 2014 (actual)
- First posted
- 8 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control, 0 days | No intervention | –control group, no intervention |
| 1 day | Experimental | Behavioral: School-Based Obesity Intervention (FLOW)received the intervention 1 day/week |
| 3 days | Experimental | Behavioral: School-Based Obesity Intervention (FLOW)received the intervention 3 days/week |
| 5 days | Experimental | Behavioral: School-Based Obesity Intervention (FLOW)received the intervention 5 days/week |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- BMI-for-age (Body Mass Index) percentile ≥ 85
- Male or female between ages 10 - 17 years
- Self-identified as Mexican-American
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | 1 day, 3 days, 5 days |
Primary outcome
Change in Standardized Body Mass Index (zBMI)
Time frame: baseline, 6, and 12 months
standardized body mass index
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Individual participant dataSharing planned: No. There is no plan to make IPD available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig A Johnston, PhD principal investigator
University of Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School-Based Obesity Intervention (FLOW) in people with Obesity, Child, run by University of Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Standardized Body Mass Index (zBMI) (time frame: baseline, 6, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019.