An interventional study of Family Based Behavioral Treatment in Childhood Obesity, sponsored by Seattle Children's Hospital. Completed at 1 site in United States. Open to participants aged 9 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-06.
Sponsored by Seattle Children's Hospital · Not applicable, Interventional, and Basic science
BASIC fMRI is a prospective single center intervention trial using fMRI imaging in 9-11 year old obese male and females pre and post family-based behavioral treatment of 24 weeks duration to determine the relationship between impulsivity and central satiety responses.
The high prevalence of childhood obesity in the U.S. demands a better understanding of factors that drive weight gain and influence the outcome of pediatric obesity interventions. This project investigates the hypothesis that, as in adults, a subset of obese children experience a diminished satiety response to food consumption, and that these children are more resistant to gold standard family-based behavioral treatment (FBT) for obesity. FBT is targeted almost exclusively toward parents; however, there is evidence that obesity development and response to intervention may depend on additional factors such as individual internal satiety perception and variability in the function of brain centers associated with impulsivity and reward. The proposed research uses functional magnetic resonance imaging (fMRI) to characterize brain function related to satiety and examines fMRI along with behavioral, cognitive, and hormonal testing to fully examine potential mediators of children's experience of satiety and response to FBT. The approach is based on evidence that failure to attenuate the reward value of palatable foods after eating can be a manifestation of a blunted central satiety response that is reliably detected using fMRI. Key objectives will be to determine if differences in the central satiety response exist between obese and non-obese children, and, among obese children, if the strength of the central satiety response is associated with impulsivity and/or the success of obesity treatment. The central hypothesis is that, in obese children, a blunted central nervous system satiety response impairs the success of obesity interventions. To achieve study objectives, brain activation by high-calorie visual food cues before and after food consumption will be measured by fMRI. Participants will be obese and non-obese children aged 9-11 years. The 49 obese children will be evaluated before and after they participate in a 6-month evidence-based FBT intervention. Their pre-intervention fMRI will be compared to those of 20 non-obese controls to test for a blunted central satiety response (Aim 1). The relationship of impulsivity to satiety responses and food intake will be determined in obese children (Aim 2). The longitudinal component tests whether central satiety responses prior to treatment predict treatment outcomes (Aim 3A) and whether changes in central satiety responses during treatment predict maintenance of reduced weight 6 and 12 months after treatment cessation (Aim 3B). Behavioral, cognitive, and hormonal measures will be examined as potential mediating or confounding factors contributing to fMRI responses. The proposed research is guided by an integrated, transdisciplinary team with expertise in pediatric and adult neuroimaging, appetite regulation, and family-based childhood obesity treatment. This research will provide new insights into the neurobiological basis of child obesity and the relevance of neurobiological factors to treatment success. The long-term objective is to translate these findings to improve obesity interventions cost-effectively and sustain better long-term results.
During years 1-3, obese children will be enrolled into intervention groups of 9-11 families with staggered start dates by 3-6 months. Years 1-4 includes enrollment, intervention, longitudinal follow-up, and data collection for obese children. Control children will primarily be recruited during years 2-3 to facilitate matching. FMRI scans are processed on a rolling basis as studies are completed. In years 3 and 4 hormonal assays will be performed. Final data analyses will be completed in year 4.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 81 is close to the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Seattle Children's Hospital is the lead sponsor of 210 studies on the registry; 43 are open to participants now.
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Exclusion Criteria:
Central satiety brain and hormonal responses will be compared pre-and post-Family Based Behavioral Treatment, as well, as to a non-obese sample.
Behavioral: Family Based Behavioral Treatment
Obese children accompanied by at least one parent or caregiver will attend 24 weekly in-person sessions. Sessions will include 25-30 min. meetings between an interventionist and each child/parent pair to individualize treatment, followed by separate child and parent group meetings lasting 40 - 45 min. Parents will serve as primary agents of change for their child and for themselves. Training will focus on food and physical activity education, parenting around food and physical activity, and use of behavioral skills (e.g., self-monitoring, environmental control, contingency management). Intervention groups of 9-11 children/families will be initiated every 3-6 mos. in study yrs. 1-3.
Blunted central satiety response measured by functional magnetic resonance imaging
Time frame: Baseline
Change of brain response to visual food cues or eating behavior measured by functional magnetic resonance imaging
Time frame: Change from pre- to post-treatment (end of 6 month intervention)
Relationship between impulsivity and satiety in obese children as measured by functional magnetic resonance imaging.
Time frame: Change from pre- to post-treatment (end of 6 month intervention)
Relationship between impulsivity and satiety in obese children as measured by the Relative Reinforcing Value of Food (RRV).
Time frame: Change from pre- to post-treatment (end of 6 month intervention)
Relationship between impulsivity and satiety in obese children as measured by the Developmental NEuroPSYchological Assessment (NEPSY).
Time frame: Change from pre- to post-treatment (end of 6 month intervention)
Relationship between impulsivity and satiety in obese children as measured by the Delayed Choice Questionnaire (DCQ).
Time frame: Change from pre- to post-treatment (end of 6 month intervention)
Predictors of treatment outcomes measured by functional magnetic resonance imaging.
Time frame: Change from pre- to post-treatment (end of 6 month intervention)
Predictors of treatment outcomes measured by behavioral skills use questionnaires.
Time frame: Change from pre- to post-treatment (end of 6 month intervention)
Predictors of treatment outcomes measured by hormonal measures.
Time frame: Change from pre- to post-treatment (end of 6 month intervention)
Plan to share: No
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Seattle Children's Hospital