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Brain Activation and Satiety in Children: Functional Magnetic Resonance Imaging (BASIC-FMRI)

5. september 2018 opdateret af: Christian Roth, Seattle Children's Hospital

Brain Systems and Behaviors Underlying Response to Obesity Treatment in Children

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

81

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Washington
      • Seattle, Washington, Forenede Stater, 89105
        • Seattle Childrens Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

9 år til 11 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 9-11 years of age
  • Male or female
  • Ability and willingness to participate in study visits including fMRI scans and blood draws;
  • ability to provide informed written consent and assent;
  • BMI z-score for lean control children 15th to 84.9th perc. for age and sex,
  • BMI z-score for obese children BMI z-score >90th perc. for age and sex;
  • Additional inclusion criteria for obese children: One overweight parent (BMI >25 kg/m2); willingness of 1 parent (does not have to be the obese parent) to engage in family-based weight control treatment.

Exclusion Criteria:

  • History of acute or chronic serious medical conditions;
  • known diabetes mellitus or recent (6 mo.) history of anemia;
  • presence of any implanted metal or metal devices, including ferro-metallic surgical clips or braces;
  • claustrophobia;
  • documented cognitive disorder, disruptive behavior, inability to participate in group sessions;
  • current use of medications known to alter appetite, body weight, or brain response (e.g. anti-seizure medications, glucocorticoids, medications for attention deficit disorder);
  • food intolerance or vegetarianism.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Family Based Behavioral Treatment
Central satiety brain and hormonal responses will be compared pre-and post-Family Based Behavioral Treatment, as well, as to a non-obese sample.
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Blunted central satiety response measured by functional magnetic resonance imaging
Tidsramme: Baseline
Baseline

Sekundære resultatmål

Resultatmål
Tidsramme
Change of brain response to visual food cues or eating behavior measured by functional magnetic resonance imaging
Tidsramme: Change from pre- to post-treatment (end of 6 month intervention)
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.
Tidsramme: Change from pre- to post-treatment (end of 6 month intervention)
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).
Tidsramme: Change from pre- to post-treatment (end of 6 month intervention)
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).
Tidsramme: Change from pre- to post-treatment (end of 6 month intervention)
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).
Tidsramme: Change from pre- to post-treatment (end of 6 month intervention)
Change from pre- to post-treatment (end of 6 month intervention)

Andre resultatmål

Resultatmål
Tidsramme
Predictors of treatment outcomes measured by functional magnetic resonance imaging.
Tidsramme: Change from pre- to post-treatment (end of 6 month intervention)
Change from pre- to post-treatment (end of 6 month intervention)
Predictors of treatment outcomes measured by behavioral skills use questionnaires.
Tidsramme: Change from pre- to post-treatment (end of 6 month intervention)
Change from pre- to post-treatment (end of 6 month intervention)
Predictors of treatment outcomes measured by hormonal measures.
Tidsramme: Change from pre- to post-treatment (end of 6 month intervention)
Change from pre- to post-treatment (end of 6 month intervention)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Christian Roth, MD, Seattle Children's

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2014

Primær færdiggørelse (Faktiske)

1. juli 2018

Studieafslutning (Faktiske)

1. august 2018

Datoer for studieregistrering

Først indsendt

20. november 2014

Først indsendt, der opfyldte QC-kriterier

25. juni 2015

Først opslået (Skøn)

30. juni 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. september 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. september 2018

Sidst verificeret

1. september 2018

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

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INGEN

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Kliniske forsøg med Fedme hos børn

Kliniske forsøg med Family Based Behavioral Treatment

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