Pediatric ObesityACCEPTNCT03368716
Acceptance-based Care for Child Eating and Physical Activity Treatment
A study testing Acceptance-based Behavioral Treatment (ABBT) in people with Pediatric Obesity and Executive Function, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to develop and pilot test a new type of patient-centered, family-based treatment for children aged 8-12 with obesity and their caregivers. The treatment will focus specifically on improving children's self-regulation (SR) skills to help them better manage their feelings, behaviors, and… Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity, Executive Function, Self-Regulation
- What is being tested?
- Acceptance-based Behavioral Treatment (ABBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2019to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children who: (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 caregiver; (4) plan to stay living in the local area during the study period; (5) have a consenting caregiver who can commit to all study procedures and provide reliable travel.
Who cannot join
- Children who:(1) comorbid developmental/intellectual disability/traumatic brain injury/other identified condition known to substantially impact EF and/or weight management; (2) taking medication that is known to affect weight or appetite, (3) recent infection that may cause confounds of acute inflammation, (4) have an uncorrected visual or hearing impairment that would prohibit completion of cognitive testing, and (5) are unable to use an iPad with appropriate training for cognitive testing. The children without obesity (n=32) will have "normal-range" BMI scores (5th ≤BMI percentile< 85th) but otherwise follow the same inclusion/exclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35209
About this study
Official title: Addressing Healthcare Disparities in Pediatric Obesity Treatment: Development of a Novel, Patient-centered Intervention Targeting Executive Function
The purpose of this study is to develop and pilot test a new type of patient-centered, family-based treatment for children aged 8-12 with obesity and their caregivers. The treatment will focus specifically on improving children's self-regulation (SR) skills to help them better manage their feelings, behaviors, and thoughts to help them live a healthier lifestyle.
Read the detailed description
We aim to: (1) To determine the treatment needs of children ages 8-12 with obesity and their families with a focus on understanding cognitive function challenges that are related to self-regulation (using focus groups i.e. FG and feedback sessions i.e. FB). (2) To evaluate the feasibility and acceptability of this novel family-based treatment. (3) Explore potential associations between pediatric cardiovascular (CVD) risk factors and self-regulation in children with and without overweight or obesity. (4) To refine the F-ABT protocol and to maximize participant feasibility, acceptability, safety, and tolerability of F-ABT. (5) To provide pilot, proof-of-concept, and preliminary efficacy data of beneficial effects of F-ABT on SR and BMI in children with SR deficits and their caregivers.
- Conditions
- Pediatric Obesity, Executive Function, Self-Regulation
- Being tested
- Acceptance-based Behavioral Treatment (ABBT)
- Keywords
- Pediatric Obesity, Executive Function, Behavioral Intervention, Self-Regulation, Acceptance-Based
- Medical subject headings
- Pediatric Obesity, Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance-based Behavioral Treatment (ABBT)Behavioural
ABBT is rooted in behavioral therapy but also cultivates self-regulation skills including experiential acceptance of potentially uncomfortable internal experiences (e.g., emotions, cravings), mindful awareness of decision making (e.g., mindful eating), and values clarification and behavioral commitment (e.g., practicing daily physical activity to be a contributing member on a sports team). ABBT has been used effectively to help youth and adults manage various medical and psychological problems. Moreover, components of ABBT have been shown to improve child and adult EF including inhibitory control and cognitive flexibility. Recently, ABBT has been integrated with components of standard behavioral treatment of obesity and applied with robust efficacy to weight management in adults.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance-based Behavioral Treatment | Experimental | Family acceptance-based behavioral treatment (ABBT) will be piloted with 16 child-caregiver pairs. At weeks 0 (pre-treatment), 9 (mid-treatment), and 18 (post-treatment), feedback regarding the feasibility and acceptability will be collected from participants through surveys and semi-structured group interviews to refine the family ABBT protocol. Receives: Behavioral: Acceptance-based Behavioral Treatment (ABBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in child body mass index
Child height and weight measurements will be converted to zBMI using CDC age and sex specific scales.
Measured: Baseline to 4.5 months
Change in child objective executive function
Performance-based EF will be tested using the NIH Toolbox Cognitive Battery which measures executive function (inhibitory control and cognitive flexibility), attention, episodic memory, language, processing speed, and working memory. T-scores will be used for each domain. Higher t-scores indicate better function.
Measured: Baseline to 4.5 months
Change in child subjective executive function
Subjective EF will be measured using the Behavioral Rating Inventory of Executive Function. The Global Severity Index will be used which is interpreted using T-scores. Higher t-scores indicate better function.
Measured: Baseline to 4.5 months
Change in Health-Related Quality of Life
Sizing Me Up© \& Sizing Them Up© are validated obesity-specific self-report and parent-report measures, respectively, of health-related quality of life for children 5-13 years old that measure functioning in a variety of areas (e.g., emotional, physical, teasing/marginalization). The Total Score will be used as the outcome, which is a scaled score ranging from 0-100 with higher scores representing better quality of life.
Measured: Baseline to 4.5 months
Cortisol
ug/dl
Measured: Baseline to 4.5 months
Blood pressure
Systolic over diastolic
Measured: Baseline to 4.5 months
Fasting glucose
mg/dl
Measured: Baseline to 4.5 months
Low-density lipoprotein (LDL-C) cholesterol
mg/dl
Measured: Baseline to 4.5 months
High-density lipoprotein (HDL-C) cholesterol
mg/dl
Measured: Baseline to 4.5 months
Triglyceride
mg/dl
Measured: Baseline to 4.5 months
Insulin
uU/ml
Measured: Baseline to 4.5 months
Hemoglobin A1C
Percentage
Measured: Baseline to 4.5 months
Leptin
ng/mL
Measured: Baseline to 4.5 months
Tumor necrosis factor (TNF-a)
pg/ml
Measured: Baseline to 4.5 months
Interleukin (IL-6)
pg/ml
Measured: Baseline to 4.5 months
High-sensitivity reactive protein (hsCRP)
mg/L
Measured: Baseline to 4.5 months
Secondary outcomes (8)
Child body fat percent
The Tanita SC-240 BIA device has been validated for use with children to assess total body fat to the nearest 0.1%. Total body fat percent will be standardized using age and sex specific CDC conversions.
Measured: Baseline to 4.5 months
Waist circumference
The Gulick II anthropometric tape will be utilized to measure children's waist circumference, which will be converted to national published standardized (z) scores.
Measured: Baseline to 4.5 months
Child eating behavior
The Children's Eating Behaviour Questionnaire is a 35-item parent proxy-report measure of eating behavior producing 8 subscales: responsiveness to food, enjoyment of food, satiety responsiveness, slowness in eating, fussiness, emotional overeating, emotional undereating, desire for drinks. Items are scored on a 5-point Likert scale and the mean score of each subscale is used. Higher scores indicate more eating behaviors in a certain domain.
Measured: Baseline to 4.5 months
Dietary behavior
Child and parent dietary habits will be assessed via self-report throughout the intervention using the online USDA SuperTracker software.
Measured: Baseline to 4.5 months
Physical activity behavior
Child and parent physical activity habits will be assessed via self-report throughout the intervention using the online USDA SuperTracker software.
Measured: Baseline to 4.5 months
Mindfulness
The Child Acceptance and Mindfulness Measure (CAMM) is a 10-item measure of children's awareness and acceptance of their own private events or internal experiences. Items are reverse scored on a 5-point Likert scale. Higher scores correspond to higher levels of mindfulness.
Measured: Baseline to 4.5 months
Psychological flexibility
The Avoidance and Fusion Questionnaire for Youth (AFQ-Y) is a 17-item self-report measure for to assess psychological inflexibility in children. Items are scored on a 5-point Likert scale and summed for a total score ranging between 0-68. Higher scores are indicative of greater psychological inflexibility. The Parental Acceptance and Action Questionnaire (PAAQ) is a 15-item measure that evaluates parents' experiential acceptance and action tendencies in the context of their relationship with their children. The Total score is used which is a sum of all items which are rated on a 7-point Likert scale. Higher scores represent a greater degree of parental experiential avoidance.
Measured: Baseline to 4.5 months
Impact of the food environment
The Children's Power of Food Scale is a 15-item self-report assessment of the psychological impact of living in food-abundant environments. Items are rated on a 5-point Likert scale and summed to create a total score. Higher scores reflect greater responsiveness to the food environment.
Measured: Baseline to 4.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start4 Feb 2019
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Kaul Pediatric Research Institute of the Alabama Children's Hospital Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Marissa Gowey, University of Alabama at Birmingham
- Investigators
- Marissa A Gowey, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368716
- Sponsor's protocol ID
- 5K12HS023009-04
- Other IDs
- 5P30DK079626-12, in progress
- Acronym
- ACCEPT
- Status last verified
- Aug 2022
- First submitted
- 29 Nov 2017
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Given the small number of participants involved in various aspects of the pilot study, we currently do not plan to widely share individual participant data to maximize confidentiality. Individual requests will be considered.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Healthcare Disparities in Pediatric Obesity Treatment: Development of a Novel, Patient-centered Intervention Targeting Executive Function
- ClinicalTrials.gov ID
- NCT03368716
- Acronym / sponsor ID
- ACCEPT / 5K12HS023009-04
- Conditions
- Pediatric Obesity, Executive Function, Self-Regulation
- Keywords
- Pediatric Obesity, Executive Function, Behavioral Intervention, Self-Regulation, Acceptance-Based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Kaul Pediatric Research Institute of the Alabama Children's Hospital Foundation, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop and pilot test a new type of patient-centered, family-based treatment for children aged 8-12 with obesity and their caregivers. The treatment will focus specifically on improving children's self-regulation (SR) skills to help them better manage their feelings, behaviors, and thoughts to help them live a healthier lifestyle.
Detailed description
We aim to: (1) To determine the treatment needs of children ages 8-12 with obesity and their families with a focus on understanding cognitive function challenges that are related to self-regulation (using focus groups i.e. FG and feedback sessions i.e. FB). (2) To evaluate the feasibility and acceptability of this novel family-based treatment. (3) Explore potential associations between pediatric cardiovascular (CVD) risk factors and self-regulation in children with and without overweight or obesity. (4) To refine the F-ABT protocol and to maximize participant feasibility, acceptability, safety, and tolerability of F-ABT. (5) To provide pilot, proof-of-concept, and preliminary efficacy data of beneficial effects of F-ABT on SR and BMI in children with SR deficits and their caregivers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acceptance-based Behavioral Treatment | Experimental | Behavioral: Acceptance-based Behavioral Treatment (ABBT)Family acceptance-based behavioral treatment (ABBT) will be piloted with 16 child-caregiver pairs. At weeks 0 (pre-treatment), 9 (mid-treatment), and 18 (post-treatment), feedback regarding the feasibility and acceptability will be collected from participants through surveys and semi-structured group interviews to refine the family ABBT protocol. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children who: (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 caregiver; (4) plan to stay living in the local area during the study period; (5) have a consenting caregiver who can commit to all study procedures and provide reliable travel.
Key exclusion criteria (1 listed)
- Children who:(1) comorbid developmental/intellectual disability/traumatic brain injury/other identified condition known to substantially impact EF and/or weight management; (2) taking medication that is known to affect weight or appetite, (3) recent infection that may cause confounds of acute inflammation, (4) have an uncorrected visual or hearing impairment that would prohibit completion of cognitive testing, and (5) are unable to use an iPad with appropriate training for cognitive testing. The children without obesity (n=32) will have "normal-range" BMI scores (5th ≤BMI percentile< 85th) but otherwise follow the same inclusion/exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance-based Behavioral Treatment (ABBT)ABBT is rooted in behavioral therapy but also cultivates self-regulation skills including experiential acceptance of potentially uncomfortable internal experiences (e.g., emotions, cravings), mindful awareness of decision making (e.g., mindful eating), and values clarification and behavioral commitment (e.g., practicing daily physical activity to be a contributing member on a sports team). ABBT has been used effectively to help youth and adults manage various medical and psychological problems. Moreover, components of ABBT have been shown to improve child and adult EF including inhibitory control and cognitive flexibility. Recently, ABBT has been integrated with components of standard behavioral treatment of obesity and applied with robust efficacy to weight management in adults. | Behavioural | Acceptance-based Behavioral Treatment |
Primary outcome
Change in child body mass index
Time frame: Baseline to 4.5 months
Child height and weight measurements will be converted to zBMI using CDC age and sex specific scales.
Change in child objective executive function
Time frame: Baseline to 4.5 months
Performance-based EF will be tested using the NIH Toolbox Cognitive Battery which measures executive function (inhibitory control and cognitive flexibility), attention, episodic memory, language, processing speed, and working memory. T-scores will be used for each domain. Higher t-scores indicate better function.
Change in child subjective executive function
Time frame: Baseline to 4.5 months
Subjective EF will be measured using the Behavioral Rating Inventory of Executive Function. The Global Severity Index will be used which is interpreted using T-scores. Higher t-scores indicate better function.
Change in Health-Related Quality of Life
Time frame: Baseline to 4.5 months
Sizing Me Up© \& Sizing Them Up© are validated obesity-specific self-report and parent-report measures, respectively, of health-related quality of life for children 5-13 years old that measure functioning in a variety of areas (e.g., emotional, physical, teasing/marginalization). The Total Score will be used as the outcome, which is a scaled score ranging from 0-100 with higher scores representing better quality of life.
Cortisol
Time frame: Baseline to 4.5 months
ug/dl
Blood pressure
Time frame: Baseline to 4.5 months
Systolic over diastolic
Fasting glucose
Time frame: Baseline to 4.5 months
mg/dl
Low-density lipoprotein (LDL-C) cholesterol
Time frame: Baseline to 4.5 months
mg/dl
High-density lipoprotein (HDL-C) cholesterol
Time frame: Baseline to 4.5 months
mg/dl
Triglyceride
Time frame: Baseline to 4.5 months
mg/dl
Insulin
Time frame: Baseline to 4.5 months
uU/ml
Hemoglobin A1C
Time frame: Baseline to 4.5 months
Percentage
Leptin
Time frame: Baseline to 4.5 months
ng/mL
Tumor necrosis factor (TNF-a)
Time frame: Baseline to 4.5 months
pg/ml
Interleukin (IL-6)
Time frame: Baseline to 4.5 months
pg/ml
High-sensitivity reactive protein (hsCRP)
Time frame: Baseline to 4.5 months
mg/L
8 secondary outcomes
Child body fat percent
Time frame: Baseline to 4.5 months
Waist circumference
Time frame: Baseline to 4.5 months
Child eating behavior
Time frame: Baseline to 4.5 months
Dietary behavior
Time frame: Baseline to 4.5 months
Physical activity behavior
Time frame: Baseline to 4.5 months
Mindfulness
Time frame: Baseline to 4.5 months
Psychological flexibility
Time frame: Baseline to 4.5 months
Impact of the food environment
Time frame: Baseline to 4.5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Individual participant dataSharing planned: No. Given the small number of participants involved in various aspects of the pilot study, we currently do not plan to widely share individual participant data to maximize confidentiality. Individual requests will be considered.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marissa A Gowey, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance-based Behavioral Treatment (ABBT) in people with Pediatric Obesity and Executive Function, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in child body mass index (time frame: Baseline to 4.5 months). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022; AzTrials last refreshed its copy on 6 Nov 2026.