Obesity, ChildhoodTake CHARGE!NCT04362280
Teens Committed to Health Through Activity, Relationships, and Good Eating
A study testing ReCHARGE and TAU in people with Obesity, Childhood, run by University of Houston at 1 site in United States.
Trial summary
This study will evaluate the preliminary efficacy of a school-based weight management program for underserved adolescents. The program was designed with a phased treatment structure to provide more intensive treatment to participants who do not respond to treatment initially. Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- ReCHARGE and TAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2018to Sep 2021
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 10-17 years old
- Student enrolled in a Physical Education (PE) class at the YES Prep Brays Oak Campus during either the 2018-2019 or 2019-2020 school year
- provides written parental consent and student assent
Who cannot join
- Is pregnant or becomes pregnant during the study.
- Is unable to participate in PE class for more than 5 consecutive school days.
- Does not meet all of the inclusion criteria listed above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Teens Committed to Health Through Activity, Relationships, and Good Eating (Take CHARGE!)
This study will evaluate the preliminary efficacy of a school-based weight management program for underserved adolescents. The program was designed with a phased treatment structure to provide more intensive treatment to participants who do not respond to treatment initially. Specifically, this study aims to examine differences in zBMI over time between students who do not respond to the first semester and receive more intensive treatment in the second semester, responders to first semester who receive more intensive treatment in the second semester, non-responders to the first semester who receive usual treatment in the second semester, and responders who receive usual treatment in the second semester at the end of the second semester, 1 year follow-up, and 2 year follow-up.
Read the detailed description
Childhood obesity has reached epidemic proportions. Schools have been identified as a focal point for intervention because children spend almost half their day in school. On average, school-based interventions have shown modest short-term improvements in weight outcomes. However, considerable individual variation is found within treatments. Current clinical guidelines for childhood obesity recommend a staged treatment approach in which every few months treatment plans are reevaluated based on an individual's progress toward weight outcomes. When an individual doesn't sufficiently progress toward outcome goals, his/her treatment is escalated to be more individualized, include more structure, and greater social support. This method parallels a treatment paradigm used in other areas of medical treatment in which medication type and dose are altered when an individual does not respond to initial care. Obesity treatment provided in the school setting does not follow a similar structure of care. Despite the recognized variation between individuals, school-based obesity interventions are typically evaluated by mean changes in weight outcomes over time. Although this is sufficient to evaluate the efficacy of a program, it does not identify individuals who are not responsive to treatment. Following clinical best practices, it is likely that treatment needs to be escalated for those who do not respond to initial treatment. Currently no escalated treatment options, like that provided in clinical settings, are available in schools. This is a critical gap given the immense individual variability to treatment response and pediatric tracking of BMI. This study will develop and evaluate an escalated school-based treatment for individuals resistant to initial treatment, called Take CHARGE! (Teens Committed to Health through Activity, Relationships, and Good Eating). Specifically, a pilot randomized control trial will A.) examine differences in zBMI between Take CHARGE and a treatment as usual condition over an academic school semester among low SES, racial/ethnic minority youth resistant to initial treatment, and will B.) determine the proportion of students resistant to school-based behavioral obesity treatment. Understanding the proportion of children who are resistant to school-based intervention is a critical first step in treating this high-risk group of children.
- Conditions
- Obesity, Childhood
- Being tested
- ReCHARGE, TAU
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReCHARGEBehavioural
During their PE class, all participants (both arms) participate in an intensive lifestyle intervention with established efficacy among this population for the academic fall semester. The following semester, participants are randomized to different treatment arms. ReCHARGE increases the intensity of treatment provided in the first semester by increasing social support and addressing common barriers youth have to adhering to intervention.
TAUBehavioural
PE class as usual led by PE teacher.
| Study group | Role | What they receive |
|---|---|---|
| ReCHARGE | Experimental | intervention intensity is increased through: the creation of family groups, greater involvement of school staff, separate lessons for females, health screeners will be home and families are invited to a nutrition counseling session with a registered dietitian. Receives: Behavioral: ReCHARGE |
| Treatment as Usual (TAU) | Active comparator | PE class as usual which consisted of choice time. Receives: Behavioral: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized BMI
Examine zBMI over the course of the intervention between study arms
Measured: up to 2 years
Secondary outcomes (1)
Social Network
students asked to list their friends in the class
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start20 Aug 2018
- Primary completionMay 2020 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies 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
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- 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
- NCT04362280
- Sponsor's protocol ID
- STUDY00001135
- Acronym
- Take CHARGE!
- Status last verified
- Apr 2020
- First submitted
- 22 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arlinghaus KR, O'Connor DP, Ledoux TA, Hughes SO, Johnston CA. A staged approach to address youth unresponsive to initial obesity intervention: a randomized clinical trial. Int J Obes (Lond). 2021 Dec;45(12):2585-2590. doi: 10.1038/s41366-021-00940-0. Epub 2021 Aug 20.
PubMed 34417553
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teens Committed to Health Through Activity, Relationships, and Good Eating (Take CHARGE!)
- ClinicalTrials.gov ID
- NCT04362280
- Acronym / sponsor ID
- Take CHARGE! / STUDY00001135
- Conditions
- Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 392 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 24 Apr 2020 (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 study will evaluate the preliminary efficacy of a school-based weight management program for underserved adolescents. The program was designed with a phased treatment structure to provide more intensive treatment to participants who do not respond to treatment initially. Specifically, this study aims to examine differences in zBMI over time between students who do not respond to the first semester and receive more intensive treatment in the second semester, responders to first semester who receive more intensive treatment in the second semester, non-responders to the first semester who receive usual treatment in the second semester, and responders who receive usual treatment in the second semester at the end of the second semester, 1 year follow-up, and 2 year follow-up.
Detailed description
Childhood obesity has reached epidemic proportions. Schools have been identified as a focal point for intervention because children spend almost half their day in school. On average, school-based interventions have shown modest short-term improvements in weight outcomes. However, considerable individual variation is found within treatments. Current clinical guidelines for childhood obesity recommend a staged treatment approach in which every few months treatment plans are reevaluated based on an individual's progress toward weight outcomes. When an individual doesn't sufficiently progress toward outcome goals, his/her treatment is escalated to be more individualized, include more structure, and greater social support. This method parallels a treatment paradigm used in other areas of medical treatment in which medication type and dose are altered when an individual does not respond to initial care. Obesity treatment provided in the school setting does not follow a similar structure of care. Despite the recognized variation between individuals, school-based obesity interventions are typically evaluated by mean changes in weight outcomes over time. Although this is sufficient to evaluate the efficacy of a program, it does not identify individuals who are not responsive to treatment. Following clinical best practices, it is likely that treatment needs to be escalated for those who do not respond to initial treatment. Currently no escalated treatment options, like that provided in clinical settings, are available in schools. This is a critical gap given the immense individual variability to treatment response and pediatric tracking of BMI. This study will develop and evaluate an escalated school-based treatment for individuals resistant to initial treatment, called Take CHARGE! (Teens Committed to Health through Activity, Relationships, and Good Eating). Specifically, a pilot randomized control trial will A.) examine differences in zBMI between Take CHARGE and a treatment as usual condition over an academic school semester among low SES, racial/ethnic minority youth resistant to initial treatment, and will B.) determine the proportion of students resistant to school-based behavioral obesity treatment. Understanding the proportion of children who are resistant to school-based intervention is a critical first step in treating this high-risk group of children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ReCHARGE | Experimental | Behavioral: ReCHARGEintervention intensity is increased through: the creation of family groups, greater involvement of school staff, separate lessons for females, health screeners will be home and families are invited to a nutrition counseling session with a registered dietitian. |
| Treatment as Usual (TAU) | Active comparator | Behavioral: TAUPE class as usual which consisted of choice time. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged 10-17 years old
- Student enrolled in a Physical Education (PE) class at the YES Prep Brays Oak Campus during either the 2018-2019 or 2019-2020 school year
- provides written parental consent and student assent
Key exclusion criteria (3 listed)
- Is pregnant or becomes pregnant during the study.
- Is unable to participate in PE class for more than 5 consecutive school days.
- Does not meet all of the inclusion criteria listed above
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 |
|---|---|---|
| ReCHARGEDuring their PE class, all participants (both arms) participate in an intensive lifestyle intervention with established efficacy among this population for the academic fall semester. The following semester, participants are randomized to different treatment arms. ReCHARGE increases the intensity of treatment provided in the first semester by increasing social support and addressing common barriers youth have to adhering to intervention. | Behavioural | ReCHARGE |
| TAUPE class as usual led by PE teacher. | Behavioural | Treatment as Usual (TAU) |
Primary outcome
Standardized BMI
Time frame: up to 2 years
Examine zBMI over the course of the intervention between study arms
1 secondary outcome
Social Network
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Derived from this study: PubMed 34417553Arlinghaus KR, O'Connor DP, Ledoux TA, Hughes SO, Johnston CA. A staged approach to address youth unresponsive to initial obesity intervention: a randomized clinical trial. Int J Obes (Lond). 2021 Dec;45(12):2585-2590. doi: 10.1038/s41366-021-00940-0. Epub 2021 Aug 20.
- Individual participant dataSharing planned: No
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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 ReCHARGE and TAU in people with Obesity, Childhood, 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 3 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: status not confirmed, as of the sponsor's last update on 24 Apr 2020. 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?
Results are not available in the source record.
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?
Standardized BMI (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04362280, which also lists 1 linked publication.
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 24 Apr 2020.