NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Pilot Study of Mobile Attention Training in Overweight Female Adolescents

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

17-CH-0014

Sponsoring Institute

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Female
Min Age: 12 Years
Max Age: 21 Years

Referral Letter Required

No

Population Exclusion(s)

Male

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Obesity;
Overweight;
Binge Eating;
Healthy Volunteers

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Behavioral: Attention Bias Retraining
Behavioral: Booster Attention Retraining

Supporting Site

National Institute of Child Health and Human Development

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.

--Back to Top--

Eligibility

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.


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Citations:

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.

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.

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Jack A. Yanovski, M.D.
National Institute of Child Health and Human Development (NICHD)
NIHBC 10 - CRC BG RM 2-3142
10 CENTER DR
BETHESDA MD 20892
(301) 496-0858
jy15i@nih.gov

Bess Bloomer
National Institute of Child Health and Human Development (NICHD)
National Institutes of Health
Building 10
Room 2-3152
10 Center Drive
Bethesda, Maryland 20892
(301) 496-4168
bess.bloomer@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT02977403

--Back to Top--

NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

Pilot Study of Mobile Attention Training in Overweight Female Adolescents

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

17-CH-0014

Sponsoring Institute

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Female
Min Age: 12 Years
Max Age: 21 Years

Referral Letter Required

No

Population Exclusion(s)

Male

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Obesity;
Overweight;
Binge Eating;
Healthy Volunteers

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Behavioral: Attention Bias Retraining
Behavioral: Booster Attention Retraining

Supporting Site

National Institute of Child Health and Human Development

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.

--Back to Top--

Eligibility

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.


--Back to Top--

Citations:

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.

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.

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Jack A. Yanovski, M.D.
National Institute of Child Health and Human Development (NICHD)
NIHBC 10 - CRC BG RM 2-3142
10 CENTER DR
BETHESDA MD 20892
(301) 496-0858
jy15i@nih.gov

Bess Bloomer
National Institute of Child Health and Human Development (NICHD)
National Institutes of Health
Building 10
Room 2-3152
10 Center Drive
Bethesda, Maryland 20892
(301) 496-4168
bess.bloomer@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT02977403

--Back to Top--