NCT01708785

Brief Summary

The purpose of this study is to optimize an obesity treatment program targeting overweight 8-12 year old children using "Cue Exposure Training".

Trial Health

87
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable obesity

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

October 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2012

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 18, 2017

Status Verified

October 1, 2017

Enrollment Period

4.9 years

First QC Date

October 11, 2012

Last Update Submit

October 16, 2017

Conditions

Obesity

Keywords

obesityoverweightoverweight childrenoverweight parentsovereatingeating in the absence of hungerfamilies with overweight childbody mass indexBMIweightchildhood obesitytreatmentcue exposure treatmentcravingshabituation to food cuespsychophysiological response to food cuesinterventionexperimentsfamily based treatmentbehavioral treatment

Outcome Measures

Primary Outcomes (2)

  • Change in overeating (Eating in the absence of hunger) from baseline at an average of 3 months and 6 months

    Reduce overeating or eating in the absence of hunger in response to food cues. Habituation to food cues.

    Change from baseline at an average of 3 months and 6 months

  • Change in child weight

    BMI, BMIz

    Change from baseline at an average of 3 and 6 months

Secondary Outcomes (5)

  • Change in parent weight from baseline at average of 3 and 6 months

    Change from baseline at average of 3 and 6 months

  • Change in attention to food cues from baseline at average of 3 and 6 months

    Change from baseline at average of 3 and 6 months

  • Change in impulsivity/Inhibition from baseline at average of 3 and 6 months

    Change from baseline at average of 3 and 6 months

  • Change in psychophysiological measures of responsivity to food cues from baseline at average of 3 and 6 months

    Change from baseline at average of 3 and 6 months

  • Change in level of self-reported cravings in response to palatable food cues from baseline at average of 3 and 6 months

    Change from baseline at average of 3 and 6 months

Study Arms (4)

Single context

ACTIVE COMPARATOR

Subjects will be exposed to food cues in a single context.

Behavioral: Partial Reinforcement - Enhanced Cue Exposure TreatmentBehavioral: Partial Reinforcement -Consistent Cue Exposure Treatment

Multiple contexts

EXPERIMENTAL

Subjects will be exposed to food cues in multiple contexts.

Behavioral: Partial Reinforcement - Enhanced Cue Exposure TreatmentBehavioral: Partial Reinforcement -Consistent Cue Exposure Treatment

8 treatment sessions

ACTIVE COMPARATOR

Subjects receive 8 treatment sessions.

Behavioral: Single food Cue Exposure TreatmentBehavioral: Multiple food Cue Exposure Treatment

16 treatment sessions

EXPERIMENTAL

Subjects receive 16 treatment sessions

Behavioral: Single food Cue Exposure TreatmentBehavioral: Multiple food Cue Exposure Treatment

Interventions

Single food Cue Exposure TreatmentBEHAVIORAL

Subjects will be exposed to the same set of 4 foods in each cue exposure treatment session.

16 treatment sessions8 treatment sessions
Multiple food Cue Exposure TreatmentBEHAVIORAL

Subjects will be exposed to a different set of 4 foods in each cue exposure treatment session.

16 treatment sessions8 treatment sessions
Partial Reinforcement - Enhanced Cue Exposure TreatmentBEHAVIORAL

Subjects will take random additional tastes of the food during cue exposure treatment.

Multiple contextsSingle context
Partial Reinforcement -Consistent Cue Exposure TreatmentBEHAVIORAL

Subjects will consistently take the same tastes of the food during cue exposure treatment.

Multiple contextsSingle context

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Response to an advertisement for the study,
  • An overweight or obese child in the family who is between the ages of 8 and 13,
  • The 8-13 year old child must be above the 85th BMI % for age and gender,
  • Parent willing to participate and attend all meetings,
  • Parent who can read at a minimum of a 5th grade level in English,
  • Parent and child willing to commit to attendance and assessments,
  • Child who eats in the absence of hunger.

You may not qualify if:

  • Major child psychiatric disorder diagnoses,
  • An obese child over the 99.9th BMI %
  • Child or parent diagnoses of diabetes for which physician supervision of diet is needed or diagnosis of serious current physical diseases (such as cancer, multiple sclerosis, lupus) which could significantly decrease their ability to participate in the intervention (parent report),
  • Child taking a medication that can affect cognitive functioning, such as attention, concentration, or mental status.
  • Family with restrictions on types of food, such as food allergies, or religious or ethnic practices that limit the foods available in the home (these restrictions affect their ability participate in the food exposures because it would limit the variety of foods available to do exposures with),
  • Child with an active eating disorder (based on parent and child self-report)
  • Major parent psychiatric or eating disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Health Eating and Activity Research

La Jolla, California, 92037, United States

Location

Related Publications (4)

  • Boutelle KN, Zucker NL, Peterson CB, Rydell SA, Cafri G, Harnack L. Two novel treatments to reduce overeating in overweight children: a randomized controlled trial. J Consult Clin Psychol. 2011 Dec;79(6):759-71. doi: 10.1037/a0025713.

    PMID: 22122291BACKGROUND

  • Epstein LH, Myers MD, Raynor HA, Saelens BE. Treatment of pediatric obesity. Pediatrics. 1998 Mar;101(3 Pt 2):554-70.

    PMID: 12224662BACKGROUND

  • Nederkoorn C, Smulders FT, Jansen A. Cephalic phase responses, craving and food intake in normal subjects. Appetite. 2000 Aug;35(1):45-55. doi: 10.1006/appe.2000.0328.

    PMID: 10896760BACKGROUND

  • Nederkoorn C, Jansen A. Cue reactivity and regulation of food intake. Eat Behav. 2002 Spring;3(1):61-72. doi: 10.1016/s1471-0153(01)00045-9.

    PMID: 15001020BACKGROUND

MeSH Terms

Conditions

ObesityOverweightHyperphagiaBody WeightPediatric Obesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Kerri Boutelle, Ph.D.

    UCSD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 11, 2012

First Posted

October 17, 2012

Study Start

October 1, 2012

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

October 18, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)