Mobile Attention Retraining in Overweight Female Adolescents

NCT02977403 | Completed Results

• 2 other identifiers: 17001417-CH-0014
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Background: People are constantly exposed to unhealthy foods. Some studies of adults show that training attention away from unhealthy foods might reduce overeating. Researchers want to see what happens in the brain when teens train their attention away from food through a program on a smartphone. Objective: To study the relationship between eating patterns, body weight, and how the brain reacts to different images. Eligibility: Right-handed females ages 12-17 who are overweight (Body Mass Index at or above the 85th percentile for age). Design: Participants will have 6 visits over about 8 months. Visit 1: participants will be screened with: Height, weight, blood pressure, and waist size measurements Medical history Physical exam Urine sample DXA scan. Participants will lie on a table while a very small dose of x-rays passes through the body. Questions about their general health, social and psychological functioning, and eating habits Parents or guardians of minor participants will answer questions about their child s functioning and demographic data. Before visits 2-6, participants will not eat or drink for about 12 hours. These visits will include some or all of these procedures: Blood drawn MRI scan. Participants will lie on a stretcher that slides in and out of a metal cylinder in a strong magnetic field. A device will be placed over the head. Meals provided. Participants will fill out rating forms. Simple thinking tasks A cone containing magnetic field detectors placed onto the head Medical history Physical exam Urine sample Participants will be assigned to a 2-week smartphone program that involves looking at pictures. Participants will complete short tasks and answer some questions about their eating habits and mood on the smartphone.

Conditions

Obesity; Overweight; Binge Eating; Healthy Volunteers

Keywords

Binge Eating; Eating Behavior; Children; Magnetoencephalography; Loss of Control

Outcome Measures

Primary Outcomes (53)

• Changes in Food-cue Visual Probe Task Attention Bias (AB) Reaction Time

  AB was obtained for each stimulus pairing (High-Palatability Food \[HPF\] minus Non-Food \[NF\] image, Low-Palatability Food \[LPF\] minus NF image, HPF minus LPF image). Trials where the probe appeared behind the more food-salient cue (e.g., a HPF image, or LPF vs NF image) were considered congruent trials. Trials where the probe appeared behind the less salient cue (e.g., NF image, or LPF image when the other image was a HPF image) were considered incongruent trials. The average reaction time during incongruent trials was subtracted from reaction time during during congruent trials. Positive scores represent a quicker reaction time for (and bias towards) the more palatable stimulus, and negative scores represent a slower reaction time for (and bias away from) the more palatable stimulus. A difference score of 0 represents no bias towards or away from the more palatable stimulus. Only trials with correct responses for the direction of the probe were included in computations.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudate Left Hemisphere During Attention Capture (0-250ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power at the caudate left hemisphere during attention capture (0-250ms following stimulus). Oscillatory power was normalized as per NeuroImage 39 (2008) pp 1788-1802, by estimating noise power as ρθ = WθTΣWθ (where Wθ is a (M × 1) column vector of weighting parameters that are tuned specifically to the location and orientation represented by θ, Σ represents the noise covariance matrix and ρθ is the beamformer-projected sensor noise power at the location and orientation θ). Within each stimuli-pairing and attention phase, oscillatory power during the incongruent trials was divided by oscillatory power during the congruent trials, then log transformed. Given a ratio was used, the oscillator power outcomes are unitless. Change in power (post-intervention minus pre-intervention) was calculated. Positive changes represent an increase in oscillatory power from pre- to post intervention.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudate Right Hemisphere During Attention Capture (0-250ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudate right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pallidum Left Hemisphere During Attention Capture (0-250ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pallidum left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pallidum Right Hemisphere During Attention Capture (0-250ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pallidum right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Putamen Left Hemisphere During Attention Capture (0-250ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the putamen left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Putamen Right Hemisphere During Attention Capture (0-250ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the putamen right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Anterior Cingulate Cortex Left Hemisphere During Attention Capture (0-250ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudal anterior cingulate cortex left hemisphere - during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Anterior Cingulate Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudal anterior cingulate cortex right hemisphere - during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Anterior Cingulate Cortex Left Hemisphere - During Attention Capture (0-250ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the rostral anterior cingulate cortex left hemisphere - during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Anterior Cingulate Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the rostral anterior cingulate cortex right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Lateral Orbitofrontal Cortex Left Hemisphere During Attention Capture (0-250ms Following Stimulus)

  Neural activity during a food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the lateral orbitofrontal cortex left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Lateral Orbitofrontal Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the lateral orbitofrontal cortex right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Medial Orbitofrontal Cortex Left Hemisphere During Attention Capture (0-250ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the medial orbitofrontal cortex left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Medial Orbitofrontal Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the medial orbitofrontal cortex right hemisphere during attention capture (0-250ms following stimulus).The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Dorsolateral Prefrontal Cortex Left Hemisphere During Attention Capture (0-250ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudal dorsolateral prefrontal cortex left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Dorsolateral Prefrontal Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudal dorsolateral prefrontal cortex right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Dorsolateral Prefrontal Cortex Left Hemisphere During Attention Capture (0-250ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the rostral dorsolateral prefrontal cortex left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Dorsolateral Prefrontal Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the rostral dorsolateral prefrontal cortex right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Superior Dorsolateral Prefrontal Cortex Left Hemisphere During Attention Capture (0-250ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the superior dorsolateral prefrontal cortex left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Superior Dorsolateral Prefrontal Cortex Right Hemisphere During Attention Capture (0-250ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the superior dorsolateral prefrontal cortex right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Opercularis Left Hemisphere During Attention Capture (0-250ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars opercularis left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Opercularis Right Hemisphere During Attention Capture (0-250ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars opercularis right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Orbitalis Left Hemisphere During Attention Capture (0-250ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars orbitalis left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Orbitalis Right Hemisphere During Attention Capture (0-250ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars orbitalis right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Triangularis Left Hemisphere During Attention Capture (0-250ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars triangularis left hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Triangularis Right Hemisphere During Attention Capture (0-250ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars triangularis right hemisphere during attention capture (0-250ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudate Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the the caudate left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudate Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudate right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pallidum Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pallidum left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pallidum Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pallidum right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Putamen Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the putamen left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Putamen Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the putamen right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Anterior Cingulate Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudal anterior cingulate cortex left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Anterior Cingulate Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudal anterior cingulate cortex right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Anterior Cingulate Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the rostral anterior cingulate cortex left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Anterior Cingulate Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the rostral anterior cingulate cortex right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Lateral Orbitofrontal Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the lateral orbitofrontal cortex left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Lateral Orbitofrontal Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the lateral orbitofrontal cortex right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Medial Orbitofrontal Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the medial orbitofrontal cortex left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Medial Orbitofrontal Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the medial orbitofrontal cortex right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Dorsolateral Prefrontal Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudal dorsolateral prefrontal cortex left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Caudal Dorsolateral Prefrontal Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the caudal dorsolateral prefrontal cortex right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Dorsolateral Prefrontal Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the rostral dorsolateral prefrontal cortex left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Rostral Dorsolateral Prefrontal Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the rostral dorsolateral prefrontal cortex right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Superior Dorsolateral Prefrontal Cortex Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the superior dorsolateral prefrontal cortex left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Superior Dorsolateral Prefrontal Cortex Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the superior dorsolateral prefrontal cortex right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Opercularis Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars opercularis left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Opercularis Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars opercularis right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Orbitalis Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars orbitalis left hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Orbitalis Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars orbitalis right hemisphere during attention deployment (250-500ms following stimulus).The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Triangularis Left Hemisphere During Attention Deployment (250-500ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars triangularis left hemisphere during attention deployment (250-500ms following stimulus).The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

• Change in Beta Band (13-35 Hz) Oscillatory Power During Food-cue Visual Probe Attention Bias Task in the Pars Triangularis Right Hemisphere During Attention Deployment (250-500ms Following Stimulus)

  Change in beta band (13-35 Hz) oscillatory power during food-cue visual probe attention bias task completed at the baseline laboratory visit vs. post-EMA intervention visit (conducted 2 weeks after the baseline visit) at the pars triangularis right hemisphere during attention deployment (250-500ms following stimulus). The same analysis procedure was followed as described in detail for the first primary outcome.

  2-weeks

Secondary Outcomes (1)

• Frequency of Loss-of-control Eating Episodes

  2-weeks

Study Arms (2)

AB Retraining

EXPERIMENTAL

Active treatment - the probe always replaces the neutral picture. There is a perfect correlation between picture type and probe location.

Behavioral: Attention Bias Retraining

Control sham

SHAM COMPARATOR

Sham Comparator program - the probe randomly replaces the neutral or food picture. There is no correlation between picture type and probe location

Behavioral: Sham Comparator: AB Control

Interventions

Attention Bias Retraining BEHAVIORAL

Attention retraining program on smartphone where the probe always replaces the neutral picture. There is a perfect correlation between picture type and probe location.

AB Retraining

Sham Comparator: AB Control BEHAVIORAL

Sham Comparator "training" where the probe randomly replaces the neutral or food pictures. There is no correlation between picture type and probe location

Control sham

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Volunteers will qualify if they meet the following criteria:
• Age between 12 and 17 years (at the start of the study).
• Female sex.
• BMI at or above the 85th percentile for age and sex according to the Centers for Disease Control US Standards (101).
• Right handedness.
• LOC sample only:
• Greater than or equal to 1 episodes of LOC eating during the past month prior to assessment, assessed using a clinical diagnostic interview for eating disorders.
• No-LOC sample only:
• No episodes of LOC eating during the past month prior to assessment, assessed using a clinical diagnostic interview for eating disorders.

You may not qualify if:

• Individuals will be excluded (and provided treatment referrals as needed) for the following reasons:
• An obesity-related health comorbidity requiring medical treatment, such as hypertension (defined by age-, sex-, and height-specific standards) or fasting hyperglycemia consistent with diabetes.
• Presence of other major illnesses: renal, hepatic, gastrointestinal, most endocrinologic (e.g., Cushing syndrome, untreated hyper- or hypothyroidism), hematological problems or pulmonary disorders (other than asthma not requiring continuous medication). Nonserious
• medical illnesses, such as seasonal allergies, will be reviewed on a case-by-case basis.
• Regular use of any medication known to affect body weight or eating behavior (e.g., stimulants prescribed for attention deficit hyperactivity disorder, or ADHD). Medication use for non-serious conditions (e.g., acne) will be considered on a case-by-case basis.
• Current pregnancy or a history of pregnancy.
• A significant reduction in weight during the past three months, for any reason, exceeding 5% of body weight.
• Presence in the child of any significant, full-threshold psychiatric disorder based on DSM criteria (102), such as schizophrenia, bipolar disorder, alcohol or substance abuse, anorexia or bulimia nervosa, or any other disorder that, in the opinion of the investigators, would impede competence or compliance or possibly hinder completion of the study. These individuals will not be permitted to enroll in the current study and will be referred for treatment. Individuals who present with other psychiatric disorders, including subthreshold psychiatric disorders, will be permitted to enroll in the study. If, based on the opinion of the investigators, a participant requires treatment for his/her psychiatric symptoms, the individual will be referred for treatment. Participants who develop any psychiatric disorder or significant psychiatric symptoms at any follow-up assessment during the study will be excluded and be provided with treatment referrals.
• Current and regular substance use, including the use of alcohol and/or tobacco products (including e-cigarettes).
• A history of significant or recent brain injury that may considerably influence performance (i.e., any history of loss of consciousness greater than or equal to 30 minutes associated with a head injury, any history of memory loss or hospitalization associated with a head injury, or greater than or equal to 2 concussions within last year).
• Current involvement in a weight loss program, participating in psychotherapy aimed at weight loss or treatment of eating behavior (e.g., binge eating).
• All parents/guardians will be asked to indicate if their child has any food allergies. To be conservative, children who report allergies to gluten, nuts, dairy, fruit, or any other item in the array, will be excluded from the test meal portion of the study.
• A condition under which MEG is contradicted (e.g., metal in the body, pregnancy, claustrophobia, history of significant neurological insult or injury).
• Non-English speaking participants will be excluded from the study as they may be unable to complete questionnaires and follow the instructions which are only provided in English.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Shank LM, Tanofsky-Kraff M, Nelson EE, Shomaker LB, Ranzenhofer LM, Hannallah LM, Field SE, Vannucci A, Bongiorno DM, Brady SM, Condarco T, Demidowich A, Kelly NR, Cassidy O, Simmons WK, Engel SG, Pine DS, Yanovski JA. Attentional bias to food cues in youth with loss of control eating. Appetite. 2015 Apr;87:68-75. doi: 10.1016/j.appet.2014.11.027. Epub 2014 Nov 27.

  PMID: 25435490 BACKGROUND

• Waters AM, Lipp OV, Spence SH. Attentional bias toward fear-related stimuli: an investigation with nonselected children and adults and children with anxiety disorders. J Exp Child Psychol. 2004 Dec;89(4):320-37. doi: 10.1016/j.jecp.2004.06.003.

  PMID: 15560877 BACKGROUND

• Jarcho JM, Tanofsky-Kraff M, Nelson EE, Engel SG, Vannucci A, Field SE, Romer AL, Hannallah L, Brady SM, Demidowich AP, Shomaker LB, Courville AB, Pine DS, Yanovski JA. Neural activation during anticipated peer evaluation and laboratory meal intake in overweight girls with and without loss of control eating. Neuroimage. 2015 Mar;108:343-53. doi: 10.1016/j.neuroimage.2014.12.054. Epub 2014 Dec 27.

  PMID: 25550068 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Obesity; Overweight; Bulimia; Feeding Behavior

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperphagia; Signs and Symptoms, Digestive; Behavior, Animal; Behavior

Limitations and Caveats

The primary study limitation was the small sample size and difficulties with recruitment. Other limitations include a large percentage of missing MEG data. Girls who provided complete data were, on average, older than participants who had missing data. Lastly, visual probe tasks have been shown to have relatively poor psychometric reliability.

Results Point of Contact

• Title: Dr. Jack Yanovski
• Organization: Eunice Kennedy Shriver National Institute of Health, NIH

jy15i@nih.gov

301-496-0858

Study Officials

• Jack A Yanovski, M.D.

  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assignment to intervention or control made by a person who has no contact with study subjects to place the appropriate program on the phone used by the subject. Blind was maintained until all subjects had completed all assessments for the randomized phase.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Model Details: Overweight youth with loss of control over eating randomized to intervention or control groups Overweight youth without loss of control over eating randomized to intervention or control groups

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: November 30, 2016
• Study Start: February 10, 2017
• Primary Completion: June 8, 2023
• Study Completion: November 13, 2024
• Last Updated: May 31, 2025
• Results First Posted: August 20, 2024

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: NIH subject data will become available starting 6 months after publication of a results paper and will be available from the NIH site for 2 years.
• Access Criteria: NIH data with personal identifiers removed will be shared upon reasonable request to the PI, who will review requests. A data sharing agreement will be required to be negotiated with NICHD before sharing takes place.

Locations

US (1)