NCT03375853

Brief Summary

This project will test whether a food response training intervention produces lasting body fat loss, use objective brain imaging to examine the mechanism of effect of this treatment and investigate the generalizability of the training to non-training foods, and examine factors that should amplify intervention effects to provide a test of the intervention theory. This novel treatment represents a bottom-up implicit training intervention that does not rely on executive control, prolonged caloric deprivation, and expensive clinicians to deliver, like behavioral weight loss treatments that have not produced lasting weight loss. If this computer-based response training intervention produces sustained body fat loss in overweight individuals, it could be easily implemented very broadly at almost no expense, addressing a leading public health problem.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
179

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jul 2017

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

First Submitted

Initial submission to the registry

May 17, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

July 15, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

6.1 years

First QC Date

May 17, 2017

Last Update Submit

September 22, 2023

Conditions

Keywords

ObesityDissonanceResponse TrainingEating DisorderComputer-based Training

Outcome Measures

Primary Outcomes (1)

  • Body Fat Change

    Change in participant's body fat percentage

    Baseline, 1 month, 3 months, 6 months, 12 months

Secondary Outcomes (14)

  • Change in Eating Disorder Symptoms

    Baseline, 1 month, 3 months, 6 months, 12 months

  • Dietary Restraint, Emotional Eating, and External Eating

    Baseline, 1 month, 3 months, 6 months, 12 months

  • Change in Disinhibited Eating Behavior

    Baseline, 1 month, 3 months, 6 months, 12 months

  • Change in Eating in the Absence of Hunger Behavior

    Baseline, 1 month, 3 months, 6 months, 12 months

  • Change in Food Addiction Behavior

    Baseline, 1 month, 3 months, 6 months, 12 months

  • +9 more secondary outcomes

Study Arms (2)

Control Condition

ACTIVE COMPARATOR

Participants will complete computer based response training tasks that will incorporate pictures of birds, flowers, and mammals. As part of the computer based training, participants will be instructed to respond or inhibit response to certain of these stimuli in order to bring about a change in the participant response to certain stimuli. These tasks will be structured identically to those presented in the experimental condition, only the appearance and context of the stimuli will be different (i.e., non-food versus food items). The computer tasks described above comprise the Generic Response Training Control Intervention.

Behavioral: Generic Response Training Control Intervention

Experimental Condition

EXPERIMENTAL

Participants will complete computer-based response training tasks that will incorporate pictures of healthy food, unhealthy food, and glasses of water. As part of the computer-based training, participants will be instructed to respond or inhibit responses to certain of these stimuli in order to bring about a change in the participant response to certain stimuli. These tasks will be structured identically to those presented in the control condition, only the appearance and context of the stimuli will be different (i.e., food versus non-food items). The computer tasks described above comprise the Computer Based Response Training Weight Loss Intervention. To optimize the intervention, we narrowed the low-calorie food stimulus set to make a better distinction between high-calorie and low-calorie foods and we changed the filler images (water and furry mammals) in the go/no-go task from 100% "go" to 50% "go" and 50% "no-go" to measure learning of stimulus-specific respond associations.

Behavioral: Computer Based Response Training Weight Loss Intervention

Interventions

Participants complete four computer based training tasks each visit, over the course of a few lab visits. Participants then perform weekly booster sessions in a more natural home or community environment over the internet using the same computer based training tasks.

Experimental Condition

Participants complete four computer based training tasks each visit, over the course of a few lab visits. Participants then perform weekly booster sessions in a more natural home or community environment over the internet using the same computer based training tasks.

Control Condition

Eligibility Criteria

Age18 Years - 38 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Body Mass Index Between 25 and 35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

Related Publications (1)

  • Yokum S, Bohon C, Berkman E, Stice E. Test-retest reliability of functional MRI food receipt, anticipated receipt, and picture tasks. Am J Clin Nutr. 2021 Aug 2;114(2):764-779. doi: 10.1093/ajcn/nqab096.

MeSH Terms

Conditions

ObesityHyperphagiaFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveMental Disorders

Study Officials

  • Eric Stice, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2017

First Posted

December 18, 2017

Study Start

July 15, 2017

Primary Completion

August 31, 2023

Study Completion

September 15, 2023

Last Updated

September 26, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations