Pediatric ObesityCARTWHEELNCT03329300
Cognitive Aspects of Response to Treatment for Weight-related Health to Improve Eating and Exercise Earlier in Life
A study testing Family-based Behavioral Treatment (FBT) in people with Pediatric Obesity and Executive Function, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
We plan to examine whether child and parental cognitive/executive function predict body composition outcomes and adherence to a 6-month protocol of Family-Based Behavioral Treatment (FBT), for pediatric obesity. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Pediatric Obesity, Executive Function
- What is being tested?
- Family-based Behavioral Treatment (FBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2018to 28 Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Have a BMI ≥ 85th percentile
- Are ≥8 and ≤12 years old at the beginning of treatment
- Can read, write, and speak English, along with their parent
- Plan to stay living within the local area during the study period
- Have a consenting parent who can commit to all study procedures and provide reliable travel.
- Siblings will be eligible for study inclusion if they meet the above criteria and will be allowed to use the same participating parent (sibling effects would then be addressed in statistical analyses).
Who cannot join
- Have been diagnosed with a medical condition and/or are taking medication known to affect appetite/weight
- Are currently participating in a formal weight management program beyond their usual medical care or have a parent participating in a formal weight management program
- Have been diagnosed with an intellectual disability or traumatic brain injury
- Have medical contraindications to physical activity.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: Using Executive Function to Predict Outcomes and Adherence in Family-based Behavioral Weight Management
We plan to examine whether child and parental cognitive/executive function predict body composition outcomes and adherence to a 6-month protocol of Family-Based Behavioral Treatment (FBT), for pediatric obesity. Our objectives are to: (1) examine the effects of parent and child complex cognitive functions on treatment outcomes and adherence in a 6-month FBT program for obesity in a diverse group of children aged 8-12 (total of 16 child-parent pairs), and (2) examine the strength of the relationship between parent and child cognitive function. We hypothesize that children with poorer executive function, and those who have parents with poorer executive function, will have poorer body composition and adherence outcomes.
Read the detailed description
Baseline assessments will include child and parent demographic data, medical history, and cognitive functioning, along with anthropometric measures such as height, weight, and body composition. Those who complete baseline assessments will be enrolled in one of two groups of family-based treatment on after-school evenings (8 pairs in each group; total of 16 child-caregiver pairs). A total of 24 weekly treatment sessions lasting up to 90 minutes each will be held over 6 months. Family-based behavioral treatment is a manualized, group intervention for children with obesity and their caregivers that incorporate participant-driven goal-based changes in diet and physical activity, and a variety of interactive educational session topics and behavioral support for reaching goals. A private weigh-in for children and caregivers will be conducted at each session. Sessions will begin with check-in with each family about weekly goal progress, after which the caregivers and children will split into separate groups for session-specific content including educational material tailored to nutrition, eating, and activity. The final portion of group session will involve children and caregivers merging in one group to share learning experiences and engage in collaborative goal-setting for the upcoming week(s). After the six month family-based behavioral intervention, baseline measures will be reassessed as well as overall program adherence. Program adherence will be evaluated using weekly program attendance and the number of days dietary/physical activity self-monitoring logs were completed.
- Conditions
- Pediatric Obesity, Executive Function
- Being tested
- Family-based Behavioral Treatment (FBT)
- Keywords
- Pediatric Obesity, Executive Function, Behavioral Intervention
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-based Behavioral Treatment (FBT)Behavioural
Family-based behavioral treatment (FBT) involves working with children and caregivers to modify diet and physical activity using behavioral strategies such as problem solving, goal setting, and self-monitoring. Children and caregivers will meet in group format on a weekly basis for 6 months. There will be 24 group session total, covering a variety of topics including nutrition, physical activity, and other aspects of health and wellness.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Other | Family-based Behavioral Treatment (FBT) Receives: Behavioral: Family-based Behavioral Treatment (FBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Child Body Fat Mass at 6 Months
Dual-energy X-ray Absorptiometry (DXA)
Measured: Baseline to 6 months
Secondary outcomes (2)
Adherence to Treatment (Number of Contact Hours)
The number of contact hours participant was exposed to treatment
Measured: Baseline to 6 months
Adherence to Treatment (Completed Days of Self-monitoring)
The number of completed days of diet/activity self-monitoring using the USDA SuperTracker software, defined by ≥2 meals and exercise minutes recorded daily.
Measured: Baseline 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 posted1 Nov 2017
- Study start4 Jun 2018
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nutrition Obesity Research Center
- Responsible party
- Principal investigator, Marissa Gowey, University of Alabama at Birmingham
- Investigators
- Marissa Gowey, PhD, Principal investigator, University of Alabama at Birmingham Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329300
- Sponsor's protocol ID
- P30DK056336-16-PF-001
- Other IDs
- P30DK056336-16
- Acronym
- CARTWHEEL
- Status last verified
- Jan 2023
- First submitted
- 25 Oct 2017
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Executive Function to Predict Outcomes and Adherence in Family-based Behavioral Weight Management
- ClinicalTrials.gov ID
- NCT03329300
- Acronym / sponsor ID
- CARTWHEEL / P30DK056336-16-PF-001
- Conditions
- Pediatric Obesity, Executive Function
- Keywords
- Pediatric Obesity, Executive Function, Behavioral Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Nutrition Obesity Research Center
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 1 Nov 2017 (actual)
- Results
- Posted 7 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We plan to examine whether child and parental cognitive/executive function predict body composition outcomes and adherence to a 6-month protocol of Family-Based Behavioral Treatment (FBT), for pediatric obesity. Our objectives are to: (1) examine the effects of parent and child complex cognitive functions on treatment outcomes and adherence in a 6-month FBT program for obesity in a diverse group of children aged 8-12 (total of 16 child-parent pairs), and (2) examine the strength of the relationship between parent and child cognitive function. We hypothesize that children with poorer executive function, and those who have parents with poorer executive function, will have poorer body composition and adherence outcomes.
Detailed description
Baseline assessments will include child and parent demographic data, medical history, and cognitive functioning, along with anthropometric measures such as height, weight, and body composition. Those who complete baseline assessments will be enrolled in one of two groups of family-based treatment on after-school evenings (8 pairs in each group; total of 16 child-caregiver pairs). A total of 24 weekly treatment sessions lasting up to 90 minutes each will be held over 6 months. Family-based behavioral treatment is a manualized, group intervention for children with obesity and their caregivers that incorporate participant-driven goal-based changes in diet and physical activity, and a variety of interactive educational session topics and behavioral support for reaching goals. A private weigh-in for children and caregivers will be conducted at each session. Sessions will begin with check-in with each family about weekly goal progress, after which the caregivers and children will split into separate groups for session-specific content including educational material tailored to nutrition, eating, and activity. The final portion of group session will involve children and caregivers merging in one group to share learning experiences and engage in collaborative goal-setting for the upcoming week(s). After the six month family-based behavioral intervention, baseline measures will be reassessed as well as overall program adherence. Program adherence will be evaluated using weekly program attendance and the number of days dietary/physical activity self-monitoring logs were completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Other | Behavioral: Family-based Behavioral Treatment (FBT)Family-based Behavioral Treatment (FBT) |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Have a BMI ≥ 85th percentile
- Are ≥8 and ≤12 years old at the beginning of treatment
- Can read, write, and speak English, along with their parent
- Plan to stay living within the local area during the study period
- Have a consenting parent who can commit to all study procedures and provide reliable travel.
Key exclusion criteria (4 listed)
- Have been diagnosed with a medical condition and/or are taking medication known to affect appetite/weight
- Are currently participating in a formal weight management program beyond their usual medical care or have a parent participating in a formal weight management program
- Have been diagnosed with an intellectual disability or traumatic brain injury
- Have medical contraindications to physical activity.
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 |
|---|---|---|
| Family-based Behavioral Treatment (FBT)Family-based behavioral treatment (FBT) involves working with children and caregivers to modify diet and physical activity using behavioral strategies such as problem solving, goal setting, and self-monitoring. Children and caregivers will meet in group format on a weekly basis for 6 months. There will be 24 group session total, covering a variety of topics including nutrition, physical activity, and other aspects of health and wellness. | Behavioural | All participants |
Primary outcome
Change From Baseline Child Body Fat Mass at 6 Months
Time frame: Baseline to 6 months
Dual-energy X-ray Absorptiometry (DXA)
2 secondary outcomes
Adherence to Treatment (Number of Contact Hours)
Time frame: Baseline to 6 months
Adherence to Treatment (Completed Days of Self-monitoring)
Time frame: Baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Marissa Gowey, PhD principal investigator
University of Alabama at Birmingham Department of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-based Behavioral Treatment (FBT) in people with Pediatric Obesity and Executive Function, run by University of Alabama at Birmingham 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 6 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 7 Nov 2023. 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?
Yes. Results are posted in the registry (first posted 7 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline Child Body Fat Mass at 6 Months (time frame: Baseline to 6 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 7 Nov 2023.