Mobile Attention Retraining in Overweight Female Adolescents

Pilot Study of Mobile Attention Training in Overweight Female Adolescents

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Overweight; Healthy Volunteers; Binge Eating
• Intervention / Treatment: Behavioral: Attention Bias Retraining; Behavioral: Booster Attention Retraining

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 Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Bess Bloomer; Phone Number: (301) 496-4168; Email: bess.bloomer@nih.gov
• Study Contact Backup: Name: Jack A Yanovski, M.D.; Phone Number: (301) 496-0858; Email: jy15i@nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

• INCLUSION CRITERIA:

Volunteers will qualify if they meet the following criteria:

1. Age between 12 and 17 years (at the start of the study).
2. Female sex.
3. BMI at or above the 85th percentile for age and sex according to the Centers for Disease Control US Standards (101).

4. Right handedness.

   LOC sample only:

5. 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:

6. 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:

1. 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.

2. 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.

3. 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.
4. Current pregnancy or a history of pregnancy.
5. A significant reduction in weight during the past three months, for any reason, exceeding 5% of body weight.
6. 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.
7. Current and regular substance use, including the use of alcohol and/or tobacco products (including e-cigarettes).
8. 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).
9. Current involvement in a weight loss program, participating in psychotherapy aimed at weight loss or treatment of eating behavior (e.g., binge eating).
10. 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.
11. A condition under which MEG is contradicted (e.g., metal in the body, pregnancy, claustrophobia, history of significant neurological insult or injury).
12. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: AB Control; Control condition - the probe is equally likely to replace the food picture and the neutral picture. There is no correlation between picture type and probe location, and no training of attention should occur.	Behavioral: Attention Bias Retraining; Attention retraining program on smartphone where the probe always replaces the neutral picture. There is a perfect correlation between picture type and probe location.
Experimental: AB Retraining; Active treatment - the probe always replaces the neutral picture. There is a perfect correlation between picture type and probe location.	Behavioral: Attention Bias Retraining; Attention retraining program on smartphone where the probe always replaces the neutral picture. There is a perfect correlation between picture type and probe location.
Other: Booster Training; 3 months after the randomized program is completed, each subject can elect to use open-label attention bias retraining for 2 weeks	Behavioral: Booster Attention Retraining; All subjects can opt to undergo attention bias training after the randomized phase of the study is complete
Active Comparator: Booster Training - active comparator; 3 months after the randomized program is completed, each subject can elect to use open-label attention bias retraining for 2 weeks	Behavioral: Booster Attention Retraining; All subjects can opt to undergo attention bias training after the randomized phase of the study is complete

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neural activity during attention bias task	Neural activity during attention bias task paradigm at the baseline laboratory visit vs. post-EMA visit	2-weeks
Changes in laboratory measured attention bias	Changes in laboratory measured attention bias at the baseline laboratory visit vs. post-EMA visit	2-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in reaction time to palatable foods	Changes in reaction times to palatable foods at the baseline laboratory visit vs. the post-EMA visit), neural activity during the social threat Attention Bias task	2-weeks
Change in eating pattern	Changes in self-reported eating patterns	2-weeks
Change in attention bias	Changes in EMA-measured attention bias	2-weeks

Collaborators and Investigators

• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Jack A Yanovski, M.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2017
• Primary Completion (Actual): June 8, 2023
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: November 29, 2016
• First Submitted That Met QC Criteria: November 29, 2016
• First Posted (Estimated): November 30, 2016

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 12, 2023

More Information

Terms related to this study

• Keywords: Children; Magnetoencephalography; Eating Behavior; Binge Eating; Loss of Control
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Overnutrition; Nutrition Disorders; Body Weight; Hyperphagia; Bulimia; Binge-Eating Disorder; Overweight
• Other Study ID Numbers: 170014; 17-CH-0014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: .All IPD that underlie results in a publication will be shared.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No