Executive Function, Pediatric Obesity
Conditions
Keywords
Pediatric Obesity, Executive Function, Behavioral Intervention
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.
Interventions
BEHAVIORALFamily-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.
Sponsors
Nutrition Obesity Research Center
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Child Body Fat Mass at 6 Months | Baseline to 6 months | Dual-energy X-ray Absorptiometry (DXA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Treatment (Number of Contact Hours) | Baseline to 6 months | The number of contact hours participant was exposed to treatment |
| Adherence to Treatment (Completed Days of Self-monitoring) | Baseline to 6 months | The number of completed days of diet/activity self-monitoring using the USDA SuperTracker software, defined by ≥2 meals and exercise minutes recorded daily. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Parent/Guardian Height | Baseline and 6 months | Height will be measured to the nearest 0.1 cm with a Seca 213 portable stadiometer. |
| Parent/Guardian Weight | Baseline and 6 months | Weight will be measured to the nearest 0.1 kg with a Tanita SC-240 bio-electrical impedance (BIA) analyzer and standard scale. |
| Change in Parent/Guardian Body Mass Index | Baseline to 6 months | 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. |
| Child Height | Baseline and 6 months | Height will be measured to the nearest 0.1 cm with a Seca 213 portable stadiometer. |
| Change in Executive Functioning - Working Memory | Baseline and 6 months | 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. |
| Change in Executive Functioning - Cognitive Flexibility | Baseline to 6 months | 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. |
| Change in Executive Functioning - Inhibitory Control | Baseline and 6 months | 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. |
| Child Weight | Baseline and 6 months | Weight will be measured to the nearest 0.1 kg with a Tanita SC-240 bio-electrical impedance (BIA) analyzer and standard scale. |
| Change in Child Body Mass Index | Baseline to 6 months | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Children There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only. | 17 |
| Parents/Caregivers There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only. | 17 |
| Total | 34 |
Baseline characteristics
| Characteristic | Children | Parents/Caregivers | Total |
|---|---|---|---|
| Age, Continuous | 12 years STANDARD_DEVIATION 1.6 | 42.3 years STANDARD_DEVIATION 8.9 | 26.21 years STANDARD_DEVIATION 17.5 |
| Child Body Fat Mass (DXA) | 48.8 %bf tblh (total body less head) STANDARD_DEVIATION 5.34 | — | 48.8 %bf tblh (total body less head) STANDARD_DEVIATION 5.34 |
| Child Body Mass Index | 2.41 Z-score STANDARD_DEVIATION 0.36 | — | 2.41 Z-score STANDARD_DEVIATION 0.36 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 13 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Executive Functioning | 52.12 t-score STANDARD_DEVIATION 11.11 | 52.71 t-score STANDARD_DEVIATION 10.7 | 52.41 t-score STANDARD_DEVIATION 10.74 |
| Height | 149.24 cm STANDARD_DEVIATION 7.27 | 163.35 cm STANDARD_DEVIATION 4.91 | 156.30 cm STANDARD_DEVIATION 9.41 |
| Parent Body Mass Index | — | 37.2 BMI Percentile STANDARD_DEVIATION 12.6 | 37.2 BMI Percentile STANDARD_DEVIATION 12.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 11 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 6 Participants | 11 Participants |
| Region of Enrollment United States | 17 participants | 17 participants | 34 participants |
| Sex: Female, Male Female | 13 Participants | 17 Participants | 30 Participants |
| Sex: Female, Male Male | 4 Participants | 0 Participants | 4 Participants |
| Weight | 74.67 kg STANDARD_DEVIATION 20.11 | 98.20 kg STANDARD_DEVIATION 32.44 | 86.44 kg STANDARD_DEVIATION 29.14 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
Primary
Change From Baseline Child Body Fat Mass at 6 Months
Dual-energy X-ray Absorptiometry (DXA)
Time frame: Baseline to 6 months
Population: DXA scans were not performed on parents.caregivers.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Children | Change From Baseline Child Body Fat Mass at 6 Months | -.96 %bf tblh (total body less head) | Standard Deviation 3.71 |
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.
Time frame: Baseline to 6 months
Population: Data were not collected; USDA Supertracker software was discontinued and thus not able to be used to collect data as planned.
Secondary
Adherence to Treatment (Number of Contact Hours)
The number of contact hours participant was exposed to treatment
Time frame: Baseline to 6 months
Population: Assessed on the dyad level
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Children | Adherence to Treatment (Number of Contact Hours) | 11.48 hours | Standard Deviation 10.49 |
Other Pre-specified
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).
Time frame: Baseline to 6 months
Population: Parent/caregiver BMI not reported as zscore
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Children | Change in Child Body Mass Index | -.05 z-score | Standard Deviation 0.05 |
Other Pre-specified
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.
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Children | Change in Executive Functioning - Cognitive Flexibility | 5.40 t-score | Standard Deviation 7.26 |
| Parents/Caregivers | Change in Executive Functioning - Cognitive Flexibility | 6.40 t-score | Standard Deviation 12.81 |
Other Pre-specified
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.
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Children | Change in Executive Functioning - Inhibitory Control | 3.3 t-score | Standard Deviation 5.43 |
| Parents/Caregivers | Change in Executive Functioning - Inhibitory Control | -2.00 t-score | Standard Deviation 5.39 |
Other Pre-specified
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.
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Children | Change in Executive Functioning - Working Memory | .40 t-score | Standard Deviation 6.36 |
| Parents/Caregivers | Change in Executive Functioning - Working Memory | 4.30 t-score | Standard Deviation 6.75 |
Other Pre-specified
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.
Time frame: Baseline to 6 months
Population: Child BMI change not calculated using raw scores.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parents/Caregivers | Change in Parent/Guardian Body Mass Index | -.48 kg/m^2 | Standard Deviation 1.02 |
Other Pre-specified
Child Height
Height will be measured to the nearest 0.1 cm with a Seca 213 portable stadiometer.
Time frame: Baseline and 6 months
Other Pre-specified
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.
Time frame: Baseline and 6 months
Other Pre-specified
Parent/Guardian Height
Height will be measured to the nearest 0.1 cm with a Seca 213 portable stadiometer.
Time frame: Baseline and 6 months
Other Pre-specified
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.
Time frame: Baseline and 6 months