Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2025-12-25 @ 5:17 PM
Study NCT ID:
NCT02977403
Status:
COMPLETED
Last Update Posted:
2025-05-31
First Post:
2016-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Mobile Attention Retraining in Overweight Female Adolescents
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Organization:
Study Overview
Official Title:
Pilot Study of Mobile Attention Training in Overweight Female Adolescents
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
Over 30% of adolescents are overweight and 20% are obese, but the mechanisms that produce excessive weight gain in youth remain incompletely elucidated. Some overweight youth appear to have an attention bias (AB: a tendency to attend selectively to stimuli that have acquired salience or meaning) toward highly palatable food that may lead to overeating. AB involves distinct cognitive processes, (1) unconscious reactions (UCR), reflecting initial attention capture evoked by salient stimuli, and (2) continued attention deployment (AD) to stimuli relevant to current goals. These rapidly evolving processes are associated with unique neurocircuitry best measured using high spatial resolution and temporal sensitivity. Magnetoencephalography (MEG) is a novel neuroimaging technology that has both excellent temporal and good spatial resolution, thus is uniquely and ideally suited to study neurocognitive mechanisms of AB. Reducing AB to palatable foods may help some overweight youth curb their consumption of energy-dense options. Attention retraining (AR) programs can be used to reduce AB and have been effective in reducing AB to unhealthy food in adults. Although most AR studies involve computers in the laboratory, using smartphones in the natural environment may be a particularly effective method to deliver AR to adolescents and measure AB using ecological momentary assessment. The first aim of the proposed study is to investigate, using MEG, the impact of a 2-week smartphone AR program on neural responses to food cues in overweight adolescent (12-17 y/o) girls with and without loss of control (LOC) eating, defined as a subjective experience of a lack of control over what or how much one is eating. LOC is a distinct eating behavior phenotype in youth that is a risk factor for excess weight gain and disordered eating, and is much more prevalent among girls (vs. boys). Overweight youth who report LOC may be particularly susceptible to AB. Additionally, adults with LOC demonstrate AB toward socially threatening cues, such as angry or disapproving faces, and the AB to social threat may be relevant to the relationship between AB to food and overweight. The second goal is to examine the effect of the 2-week AR program on AB, food intake, and body composition. An exploratory aim is to examine whether AB to socially threatening cues, moderates the effects of this novel intervention on AB to food cues, food intake, and body composition. The proposed study is innovative because no study to date has examined neurocircuitry of ABs to food using MEG, nor examined the impact of AR delivered in the natural environment on neurocircuitry of AB in a group of youth prone to AB. These studies may help further characterize phenomenology of distinct obesity subtypes and may potentially identify an approach that could prevent undue weight gain in adolescent girls at risk for obesity.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 17-CH-0014 | OTHER | NIH Clinical Center | View |