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| ID | Type | Description | Link |
|---|---|---|---|
| P30DK056336-16 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Nutrition Obesity Research Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Other | Family-based Behavioral Treatment (FBT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family-based Behavioral Treatment (FBT) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Child Body Fat Mass at 6 Months | Dual-energy X-ray Absorptiometry (DXA) | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to Treatment (Number of Contact Hours) | The number of contact hours participant was exposed to treatment | Baseline to 6 months |
| Adherence to Treatment (Completed Days of Self-monitoring) |
| Measure | Description | Time Frame |
|---|---|---|
| Child Height | Height will be measured to the nearest 0.1 cm with a Seca 213 portable stadiometer. | Baseline and 6 months |
| 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. |
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marissa Gowey, PhD | University of Alabama at Birmingham Department of Pediatrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Children | Family-based Behavioral Treatment (FBT) 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. |
| FG001 | Parents/Caregivers | Family-based Behavioral Treatment (FBT) 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Children | There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only. |
| BG001 | Parents/Caregivers | There was one group of FBT participants comprised of parent/caregiver and child dyads. Separated for reporting of results only. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline Child Body Fat Mass at 6 Months | Dual-energy X-ray Absorptiometry (DXA) | DXA scans were not performed on parents.caregivers. | Posted | Mean | Standard Deviation | %bf tblh (total body less head) | Baseline to 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Children | Family-based Behavioral Treatment (FBT) 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marissa Gowey, PhD | University of Alabama at Birmingham Department of Pediatrics | 2056386618 | marissa.gowey.phd@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 15, 2017 | Jan 25, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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|
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 |
| Baseline and 6 months |
| 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 |
| Parent/Guardian Height | Height will be measured to the nearest 0.1 cm with a Seca 213 portable stadiometer. | Baseline and 6 months |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Child Body Fat Mass (DXA) | DXA scans were not performed on parents/caregivers | Mean | Standard Deviation | %bf tblh (total body less head) |
|
| 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. Negative numbers indicate BMI values lower than the mean and positive numbers indicate BMI values higher than the mean. | Only child BMI is reported as a zscore | Mean | Standard Deviation | Z-score |
|
| Parent Body Mass Index | Only parent/caregiver BMI is reported as percentile | Mean | Standard Deviation | BMI Percentile |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Executive Functioning | BRIEF Global Executive Composite, T-score: T-scores have a population mean of 50 and a standard deviation of 10. Higher scores indicate greater executive dysfunction. Corresponding T-scores and percentiles based on age and sex are assigned using raw scores. A score of 65 or above on any scale or index suggests potential clinical impairment (Gioia et al., 2000). | Mean | Standard Deviation | t-score |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Adherence to Treatment (Number of Contact Hours) | The number of contact hours participant was exposed to treatment | Assessed on the dyad level | Posted | Mean | Standard Deviation | hours | 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. | Data were not collected; USDA Supertracker software was discontinued and thus not able to be used to collect data as planned. | Posted | Baseline to 6 months |
|
|
| Other Pre-specified | Child Height | Height will be measured to the nearest 0.1 cm with a Seca 213 portable stadiometer. | Not Posted | Baseline and 6 months | Participants |
| 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. | Not Posted | Baseline and 6 months | Participants |
| 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). | Parent/caregiver BMI not reported as zscore | Posted | Mean | Standard Deviation | z-score | Baseline to 6 months |
|
|
|
| Other Pre-specified | Parent/Guardian Height | Height will be measured to the nearest 0.1 cm with a Seca 213 portable stadiometer. | Not Posted | Baseline and 6 months | Participants |
| 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. | Not Posted | Baseline and 6 months | Participants |
| 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. | Child BMI change not calculated using raw scores. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline to 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | t-score | Baseline and 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | t-score | Baseline and 6 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | t-score | Baseline to 6 months |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Parents/Caregivers | Family-based Behavioral Treatment (FBT) 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. | 0 | 17 | 0 | 17 | 0 | 17 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|