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Mobile Attention Retraining in Overweight Female Adolescents

Primary Purpose

Obesity, Overweight, Binge Eating

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Attention Bias Retraining

Booster Attention Retraining

About this trial

This is an interventional prevention trial for Obesity focused on measuring Binge Eating, Eating Behavior, Children, Magnetoencephalography, Loss of Control

Eligibility Criteria

12 Years - 21 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

National Institutes of Health Clinical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Experimental

Other

Active Comparator

Arm Label

AB Control

AB Retraining

Booster Training

Booster Training - active comparator

Arm Description

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.

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

3 months after the randomized program is completed, each subject can elect to use open-label attention bias retraining for 2 weeks

Outcomes

Primary Outcome Measures

Neural activity during attention bias task

Neural activity during attention bias task paradigm at the baseline laboratory visit vs. post-EMA visit

Changes in laboratory measured attention bias

Changes in laboratory measured attention bias at the baseline laboratory visit vs. post-EMA visit

Secondary Outcome Measures

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

Change in eating pattern

Changes in self-reported eating patterns

Change in attention bias

Changes in EMA-measured attention bias

Full Information

NCT ID

NCT02977403

First Posted

November 29, 2016

Last Updated

July 12, 2023

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT02977403

Brief Title

Mobile Attention Retraining in Overweight Female Adolescents

Official Title

Pilot Study of Mobile Attention Training in Overweight Female Adolescents

Study Type

Interventional

2. Study Status

Record Verification Date

June 12, 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 10, 2017 (Actual)

Primary Completion Date

October 31, 2023 (Anticipated)

Study Completion Date

October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Overweight, Binge Eating, Healthy Volunteers

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AB Control

Arm Type

Sham Comparator

Arm Description

Arm Title

AB Retraining

Arm Type

Experimental

Arm Description

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

Arm Title

Booster Training

Arm Type

Other

Arm Description

3 months after the randomized program is completed, each subject can elect to use open-label attention bias retraining for 2 weeks

Arm Title

Booster Training - active comparator

Arm Type

Active Comparator

Arm Description

3 months after the randomized program is completed, each subject can elect to use open-label attention bias retraining for 2 weeks

Intervention Type

Behavioral

Intervention Name(s)

Attention Bias Retraining

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Booster Attention Retraining

Intervention Description

All subjects can opt to undergo attention bias training after the randomized phase of the study is complete

Primary Outcome Measure Information:

Title

Neural activity during attention bias task

Description

Neural activity during attention bias task paradigm at the baseline laboratory visit vs. post-EMA visit

Time Frame

2-weeks

Title

Changes in laboratory measured attention bias

Description

Changes in laboratory measured attention bias at the baseline laboratory visit vs. post-EMA visit

Time Frame

2-weeks

Secondary Outcome Measure Information:

Title

Change in reaction time to palatable foods

Description

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

Time Frame

2-weeks

Title

Change in eating pattern

Description

Changes in self-reported eating patterns

Time Frame

2-weeks

Title

Change in attention bias

Description

Changes in EMA-measured attention bias

Time Frame

2-weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bess Bloomer

Phone

(301) 496-4168

bess.bloomer@nih.gov

First Name & Middle Initial & Last Name or Official Title & Degree

Jack A Yanovski, M.D.

Phone

(301) 496-0858

jy15i@nih.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jack A Yanovski, M.D.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Institutes of Health Clinical Center

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20892

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

Phone

800-411-1222

Ext

TTY8664111010

prpl@cc.nih.gov

First Name & Middle Initial & Last Name & Degree

Bess Bloomer

Phone

(301) 496-4168

bess.bloomer@nih.gov

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

25435490

Citation

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.

Results Reference

background

PubMed Identifier

15560877

Citation

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.

Results Reference

background

PubMed Identifier

25550068

Citation

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.

Results Reference

background

Links:

URL

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2017-CH-0014.html

Description

NIH Clinical Center Detailed Web Page

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Mobile Attention Retraining in Overweight Female Adolescents

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