N/A
N=68
Mobile Attention Retraining in Overweight Female Adolescents
Obesity · Overweight · Binge Eating · Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT02977403 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Changes in Food-cue Visual Probe Task Attention Bias (AB) Reaction Time — 1.85; 4.27 Change in milliseconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Attention Bias Retraining (Behavioral); Sham Comparator: AB Control (Behavioral)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- Female
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Food-cue Visual Probe Task Attention Bias (AB) Reaction Time |
1.85; 4.27 | — |
| PRIMARY 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) |
0.010; .021 | — |
| PRIMARY 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) |
0.032; 0.023 | — |
| PRIMARY 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) |
-0.007; 0.038 | — |
| PRIMARY 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) |
0.028; 0.009 | — |
| PRIMARY 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) |
-0.013; 0.046 | — |
| PRIMARY 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) |
0.017; 0.020 | — |
| PRIMARY 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) |
0.035; -0.041 | — |
| PRIMARY 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) |
0.053; 0.002 | — |
| PRIMARY 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) |
0.012; 0.012 | — |
| PRIMARY 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) |
0.002; -0.024 | — |
| PRIMARY 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) |
-0.010; 0.026 | — |
| PRIMARY 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) |
-0.026; -0.001 | — |
| PRIMARY 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) |
-0.010; 0.018 | — |
| PRIMARY 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) |
-0.018; -0.011 | — |
| PRIMARY 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) |
0.026; 0.020 | — |
| PRIMARY 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) |
0.027; 0.031 | — |
| PRIMARY 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) |
-0.006; 0.033 | — |
| PRIMARY 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) |
0.014; 0.008 | — |
| PRIMARY 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) |
0.021; -0.013 | — |
| PRIMARY 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) |
0.041; 0.019 | — |
| PRIMARY 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) |
-0.010; 0.069 | — |
| PRIMARY 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) |
0.037; 0.031 | — |
| PRIMARY 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) |
-0.019; 0.019 | — |
| PRIMARY 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) |
-0.011; 0.016 | — |
| PRIMARY 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) |
-0.015; 0.064 | — |
| PRIMARY 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) |
0.022; 0.016 | — |
| PRIMARY 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) |
0.012; -0.052 | — |
| PRIMARY 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) |
0.030; -0.031 | — |
| PRIMARY 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) |
-0.011; -0.051 | — |
| PRIMARY 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) |
0.037; -0.026 | — |
| PRIMARY 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) |
0.0005; -0.062 | — |
| PRIMARY 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) |
0.018; -0.031 | — |
| PRIMARY 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) |
0.026; -0.069 | — |
| PRIMARY 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) |
0.058; -0.028 | — |
| PRIMARY 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) |
-0.005; -0.030 | — |
| PRIMARY 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) |
0.032; -0.012 | — |
| PRIMARY 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) |
0.021; -0.062 | — |
| PRIMARY 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) |
0.012; 0.002 | — |
| PRIMARY 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) |
0.018; -0.038 | — |
| PRIMARY 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) |
0.041; -0.009 | — |
| PRIMARY 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) |
0.016; -0.012 | — |
| PRIMARY 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) |
0.005; 0.006 | — |
| PRIMARY 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) |
0.015; -0.031 | — |
| PRIMARY 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) |
0.010; -0.006 | — |
| PRIMARY 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) |
0.004; -0.022 | — |
| PRIMARY 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) |
0.023; 0.010 | — |
| PRIMARY 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) |
0.043; -0.054 | — |
| PRIMARY 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) |
0.001; -0.018 | — |
| PRIMARY 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) |
0.013; -0.052 | — |
| PRIMARY 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) |
-0.027; 0.023 | — |
| PRIMARY 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) |
0.023; -0.071 | — |
| PRIMARY 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) |
-0.009; 0.013 | — |
| SECONDARY Frequency of Loss-of-control Eating Episodes |
.731; .827 | 0.256 |
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.
Eligibility Criteria
- INCLUSION CRITERIA:
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.
EXCLUSION CRITERIA
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.
Data sourced from ClinicalTrials.gov (NCT02977403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.