NCT02484976

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2014

Completed
7 months until next milestone

First Posted

Study publicly available on registry

June 30, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

September 6, 2018

Status Verified

September 1, 2018

Enrollment Period

3.8 years

First QC Date

November 20, 2014

Last Update Submit

September 5, 2018

Conditions

Childhood Obesity

Keywords

Family Based Behavioral Treatmentfunctional magnetic resonance imaging (fMRI)Childhood ObesitySatietyBMI z-scoreImpulsiveNon-obese controlsVisual food cuesLeptinHormones

Outcome Measures

Primary Outcomes (1)

  • Blunted central satiety response measured by functional magnetic resonance imaging

    Baseline

Secondary Outcomes (5)

  • Change of brain response to visual food cues or eating behavior measured by functional magnetic resonance imaging

    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.

    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).

    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).

    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).

    Change from pre- to post-treatment (end of 6 month intervention)

Other Outcomes (3)

  • Predictors of treatment outcomes measured by functional magnetic resonance imaging.

    Change from pre- to post-treatment (end of 6 month intervention)

  • Predictors of treatment outcomes measured by behavioral skills use questionnaires.

    Change from pre- to post-treatment (end of 6 month intervention)

  • Predictors of treatment outcomes measured by hormonal measures.

    Change from pre- to post-treatment (end of 6 month intervention)

Study Arms (1)

Family Based Behavioral Treatment

EXPERIMENTAL

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

Interventions

Family Based Behavioral TreatmentBEHAVIORAL

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.

Family Based Behavioral Treatment

Eligibility Criteria

Age9 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Childrens Hospital

Seattle, Washington, 89105, United States

Location

Related Publications (2)

  • Saelens BE, Melhorn SJ, Rowland MG, Scholz K, De Leon MRB, Elfers CT, Schur EA, Roth CL. General and Food-Specific Impulsivity and Inhibition Related to Weight Management. Child Obes. 2022 Mar;18(2):84-91. doi: 10.1089/chi.2021.0080. Epub 2021 Aug 5.

    PMID: 34357785DERIVED

  • Roth CL, Melhorn SJ, Elfers CT, Scholz K, De Leon MRB, Rowland M, Kearns S, Aylward E, Grabowski TJ, Saelens BE, Schur EA. Central Nervous System and Peripheral Hormone Responses to a Meal in Children. J Clin Endocrinol Metab. 2019 May 1;104(5):1471-1483. doi: 10.1210/jc.2018-01525.

    PMID: 30418574DERIVED

MeSH Terms

Conditions

Pediatric ObesityImpulsive Behavior

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Christian Roth, MD

    Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Christian Roth, MD

Study Record Dates

First Submitted

November 20, 2014

First Posted

June 30, 2015

Study Start

September 1, 2014

Primary Completion

July 1, 2018

Study Completion

August 1, 2018

Last Updated

September 6, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)