Cognitive Aspects of Response to Treatment for Weight-related Health to Improve Eating and Exercise Earlier in Life

Pediatric Obesity Clinical Trial

— CARTWHEEL  

Official title:

Using Executive Function to Predict Outcomes and Adherence in Family-based Behavioral Weight Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03329300
• Other study ID #: P30DK056336-16-PF-001
• Secondary ID: P30DK056336-16
• Status: Completed
• Phase: N/A
• Start date: June 4, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: January 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

1. Have a BMI = 85th percentile

2. Are =8 and =12 years old at the beginning of treatment

3. Can read, write, and speak English, along with their parent

4. Plan to stay living within the local area during the study period

5. 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:

1. Have been diagnosed with a medical condition and/or are taking medication known to affect appetite/weight

2. 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

3. Have been diagnosed with an intellectual disability or traumatic brain injury

4. Have medical contraindications to physical activity.

Related Conditions & MeSH terms

• Executive Function
• Pediatric Obesity

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Nutrition Obesity Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Child Height	Height will be measured to the nearest 0.1 cm with a Seca 213 portable stadiometer.	Baseline and 6 months
Other	Child Weight	Weight will be measured to the nearest 0.1 kg with a Tanita SC-240 bio-electrical impedance (BIA) analyzer and standard scale.	Baseline and 6 months
Other	Change in Child Body Mass Index	Body mass index z-scores are measures of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to the mean.; Change in child BMI z-score was calculated by subtracting child BMI z-score at 6 months from child BMI z-score at baseline. Negative scores indicate that BMI z-score decreased across the 6 month treatment period (i.e., better outcome), whereas positive scores indicate that BMI z-score increased from 0 to 6 months (i.e., worse outcome).	Baseline to 6 months
Other	Parent/Guardian Height	Height will be measured to the nearest 0.1 cm with a Seca 213 portable stadiometer.	Baseline and 6 months
Other	Parent/Guardian Weight	Weight will be measured to the nearest 0.1 kg with a Tanita SC-240 bio-electrical impedance (BIA) analyzer and standard scale.	Baseline and 6 months
Other	Change in Parent/Guardian Body Mass Index	Parent/guardian height and weight will be used together to determine BMI (kg/m^2). Raw BMI score at 6 months was subtracted from raw BMI score at baseline to calculate the change in BMI score from 0 to 6 months (i.e., treatment duration). Negative scores indicate a decrease in BMI (i.e., better outcome) whereas positive scores indicated an increase in BMI (i.e., worse outcome) from baseline to 6 months.	Baseline to 6 months
Other	Change in Executive Functioning - Inhibitory Control	Performance-based EF was tested using the NIH Toolbox Cognitive Battery. NIH Toolbox T-scores were used (Mean=50, Standard deviation=10). Change in EF was calculated by subtracting the T-score at 6 months from the T-score at baseline. Positive change scores indicate an improvement in EF from baseline to 6 months, whereas negative change scores indicate a decline in EF from baseline to 6 months.	Baseline and 6 months
Other	Change in Executive Functioning - Working Memory	Performance-based EF was tested using the NIH Toolbox Cognitive Battery. NIH Toolbox T-scores were used (Mean=50, Standard deviation=10). Change in EF was calculated by subtracting the T-score at 6 months from the T-score at baseline. Positive change scores indicate an improvement in EF from baseline to 6 months, whereas negative change scores indicate a decline in EF from baseline to 6 months.	Baseline and 6 months
Other	Change in Executive Functioning - Cognitive Flexibility	Performance-based EF was tested using the NIH Toolbox Cognitive Battery. NIH Toolbox T-scores were used (Mean=50, Standard deviation=10). Change in EF was calculated by subtracting the T-score at 6 months from the T-score at baseline. Positive change scores indicate an improvement in EF from baseline to 6 months, whereas negative change scores indicate a decline in EF from baseline to 6 months.	Baseline to 6 months
Primary	Change From Baseline Child Body Fat Mass at 6 Months	Dual-energy X-ray Absorptiometry (DXA)	Baseline to 6 months
Secondary	Adherence to Treatment (Number of Contact Hours)	The number of contact hours participant was exposed to treatment	Baseline to 6 months
Secondary	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.	Baseline to 6 months