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Completed

NCT Number: NCT03329300

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

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.

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Key information

Conditions

Pediatric Obesity Body Weight Executive Function Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change From Baseline Child Body Fat Mass at 6 Months

    Time frame: Baseline to 6 months

    Dual-energy X-ray Absorptiometry (DXA)

Secondary outcomes

  1. Adherence to Treatment (Number of Contact Hours)

    Time frame: Baseline to 6 months

    The number of contact hours participant was exposed to treatment

  2. Adherence to Treatment (Completed Days of Self-monitoring)

    Time frame: 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 outcomes

  1. Child Height

    Time frame: Baseline and 6 months

    Height will be measured to the nearest 0.1 cm with a Seca 213 portable stadiometer.

  2. Child Weight

    Time frame: 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.

  3. Change in Child Body Mass Index

    Time frame: 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).

  4. Parent/Guardian Height

    Time frame: Baseline and 6 months

    Height will be measured to the nearest 0.1 cm with a Seca 213 portable stadiometer.

  5. Parent/Guardian Weight

    Time frame: 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.

  6. Change in Parent/Guardian Body Mass Index

    Time frame: 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.

  7. Change in Executive Functioning - Inhibitory Control

    Time frame: 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.

  8. Change in Executive Functioning - Working Memory

    Time frame: 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.

  9. Change in Executive Functioning - Cognitive Flexibility

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Nutrition Obesity Research Center

Registry information

Official study title

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

Acronym: CARTWHEEL

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 1, 2017
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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