Cognitive Aspects of Response to Treatment for Weight-related Health to Improve Eating and Exercise Earlier in Life (CARTWHEEL)
Primary Purpose
Pediatric Obesity, Executive Function
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family-based Behavioral Treatment (FBT)
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Obesity focused on measuring Pediatric Obesity, Executive Function, Behavioral Intervention
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
All participants
Arm Description
Family-based Behavioral Treatment (FBT)
Outcomes
Primary Outcome Measures
Change from baseline child body fat mass at 6 months
Dual-energy X-ray Absorptiometry (DXA)
Secondary Outcome Measures
Adherence to treatment (sessions attended)
The number of sessions attended.
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.
Full Information
NCT ID
NCT03329300
First Posted
October 25, 2017
Last Updated
March 12, 2019
Sponsor
University of Alabama at Birmingham
Collaborators
Nutrition Obesity Research Center
1. Study Identification
Unique Protocol Identification Number
NCT03329300
Brief Title
Cognitive Aspects of Response to Treatment for Weight-related Health to Improve Eating and Exercise Earlier in Life
Acronym
CARTWHEEL
Official Title
Using Executive Function to Predict Outcomes and Adherence in Family-based Behavioral Weight Management
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 4, 2018 (Actual)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
February 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Nutrition Obesity Research Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, Executive Function
Keywords
Pediatric Obesity, Executive Function, Behavioral Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All participants
Arm Type
Other
Arm Description
Family-based Behavioral Treatment (FBT)
Intervention Type
Behavioral
Intervention Name(s)
Family-based Behavioral Treatment (FBT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline child body fat mass at 6 months
Description
Dual-energy X-ray Absorptiometry (DXA)
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Adherence to treatment (sessions attended)
Description
The number of sessions attended.
Time Frame
Baseline to 6 months
Title
Adherence to treatment (completed days of self-monitoring)
Description
The number of completed days of diet/activity self-monitoring using the USDA SuperTracker software, defined by ≥2 meals and exercise minutes recorded daily.
Time Frame
Baseline to 6 months
Other Pre-specified Outcome Measures:
Title
Child height
Description
Height will be measured to the nearest 0.1 cm with a Seca 213 portable stadiometer.
Time Frame
Baseline and 6 months
Title
Child weight
Description
Weight will be measured to the nearest 0.1 kg with a Tanita SC-240 bio-electrical impedance (BIA) analyzer and standard scale.
Time Frame
Baseline and 6 months
Title
Change in Child Body Mass Index
Description
Child height and weight measurements will be used together to determine zBMI using CDC age and sex specific scales.
Time Frame
Baseline to 6 months
Title
Parent/guardian height
Description
Height will be measured to the nearest 0.1 cm with a Seca 213 portable stadiometer.
Time Frame
Baseline and 6 months
Title
Parent/guardian weight
Description
Weight will be measured to the nearest 0.1 kg with a Tanita SC-240 bio-electrical impedance (BIA) analyzer and standard scale.
Time Frame
Baseline and 6 months
Title
Change in Parent/guardian Body Mass Index
Description
Parent/guardian height and weight will be used together to determine BMI (kg/m^2)
Time Frame
Baseline to 6 months
Title
Child executive functioning
Description
Performance-based EF will be tested using the NIH Toolbox Cognitive Battery.
Time Frame
Baseline and 6 months
Title
Parent executive functioning
Description
Performance-based EF will be tested using the NIH Toolbox Cognitive Battery. Subjective EF will be measured using the Behavioral Rating Inventory of Executive Function - Adult and Parent.
Time Frame
Baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marissa Gowey, PhD
Organizational Affiliation
University of Alabama at Birmingham Department of Pediatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
https://www.uab.edu/medicine/peds/research/division-research/gi-research/reach-lab
Description
Dr. Marissa Gowey's Research of Eating and Activity for Child Health (REACH) Lab focuses on identifying modifiable factors that are associated with response to treatment for obesity.
Learn more about this trial
Cognitive Aspects of Response to Treatment for Weight-related Health to Improve Eating and Exercise Earlier in Life
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