Low Weight Eating DisordersNCT02795455
Reward Systems and Food Avoidance in Eating Disorders
A study testing Interoceptive Exposure (IE) and meal replacement shake in people with Low Weight Eating Disorders and Anorexia Nervosa, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The researchers plan to explore brain networks involved in emotion processing and learning using a brain scan and test meals. One core feature of Anorexia Nervosa (AN) is eating a small number of high-calorie or high-fat foods. Read more about this study
- Who is it for?
- Ages 12 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Low Weight Eating Disorders, Anorexia Nervosa
- What is being tested?
- Interoceptive Exposure (IE) and meal replacement shake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 29 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Females,
- Adolescents ages 12-18,
- Speak English,
- Seeking treatment
- Refusal to maintain greater than minimally low body weight based on BMI for age percentiles and growth trajectories,
- Clinically significant restriction of food intake on the dietary restraint subscale of the EDE or evidence of persistent food avoidance as reported by patient or guardians.
Show all 10Show fewer
- Given medical clearance from pediatrician or equivalent.
- Females,
- Adolescents ages 12-18,
- Speak English.
Who cannot join
- Current psychotropic medication that would have an effect on performance on behavioral tasks (i.e., anti-anxiety medication),
- Comorbid psychotic or bipolar disorder,
- Active suicidal ideation,
- Major medical illness known to influence eating or weight,
- Current substance dependence,
- Previous exposure therapy for LW-ED.
Show all 15Show fewer
- Physical limitation that would prevent participation (e.g., allergic to chocolate),
- For patients with current or a history of sexual or physical abuse by parents, siblings, or guardians, perpetrators of the abuse will be excluded from treatment; if physical or sexual abuse by a family member occurs during the course of treatment, perpetrators will be excluded from ongoing treatment
- Healthy Comparison Adolescents
- Current psychotropic medication that would have an effect on performance on behavioral tasks (i.e., stimulant medication),
- Current or lifetime history of any psychiatric disorder, including eating disorders by K-SADS,
- Current or lifetime history of learning disorder or developmental disability
- Active suicidal ideation,
- Major medical illness,
- Other physical limitation that would prevent participation (e.g., allergic to chocolate).
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Reward Systems and Food Avoidance in Adolescents With Low Weight Eating Disorders
The researchers plan to explore brain networks involved in emotion processing and learning using a brain scan and test meals. One core feature of Anorexia Nervosa (AN) is eating a small number of high-calorie or high-fat foods. By studying why individuals with AN are disgusted by food or other eating situations, the researchers will be able to understand more about the neurobiological pathways that lead to restricting food intake and food avoidance. This study also aims to find whether one of two short-term interventions (Interoceptive Exposure (IE); Family-Based Therapy (FBT)) affects connections in the brain and if the treatments affect food avoidance. IE is an intervention that helps reduce anxiety about eating. FBT is an intervention that motivates patients to eat through working with family to increase the value of eating and decrease the value of avoiding foods.
Read the detailed description
Anorexia nervosa (AN), a characteristically relentless pursuit of thinness with an intense fear of weight gain despite significantly low body weight, is a serious psychiatric disorder with high rates of morbidity and mortality. Low weight eating disorders (LW-ED), the broader category of eating pathology that includes AN and similar variants, are characterized by a chronic course, poor response to treatment, and food avoidance. Emerging neuroimaging evidence suggests that deficits in insula-amygdala-ventral striatum (IAVS) neurocircuitry contribute to individual variability in aversive and reward learning, and that these brain regions demonstrate abnormal responses to food/eating stimuli. The researchers' pilot data suggest that patients with LW-ED experience difficulty extinguishing food-cue associations in a reversal learning paradigm compared to healthy controls, a difficulty that is related to psychophysiological measures of aversive disgust (not fear). The researchers have also successfully piloted an interoceptive exposure intervention for this population that targets visceral sensitivity and seeks to increase 'top-down' regulation of the IAVS neurocircuit. The proposed project will (a) use novel fMRI-EMG to test the relationship between effective connectivity within amygdala-insula-ventral striatum network and its relationship to psychophysiological and behavioral measures of acute threat and reward learning in 60 adolescents with LWEDs and 30 healthy controls, (b) test the sensitivity of this network to an experimental interoceptive exposure paradigm relative to patients receiving family based therapy for weight restoration using dynamic causal modeling of fMRI-EMG data pre-post experimental conditions, (c) validate this model against objective measures of laboratory and real world eating behavior. The results of this study will help better understand the core neurocircuitry that underlies both threat processing and reward/aversive learning and how this circuit relates to objective behavior. Further, the researchers will determine the modifiability of this neurocircuitry via two distinct behavioral interventions chosen to target different aspects of affective processing and reward learning. These data will be used to inform future clinical interventions targeting aversive/reward learning within this population and dysregulation in insula-amygdala-ventral striatum subcircuits.
- Conditions
- Low Weight Eating Disorders, Anorexia Nervosa
- Being tested
- Interoceptive Exposure (IE), Family Based Therapy-Weight Gain Control (FBT-WG), meal replacement shake
- Keywords
- Eating Disorders, Food Avoidance, Reward Learning, Reward System, Family-based treatment, interoceptive exposure, insula-amygdala-ventral striatum subcircuits
- Medical subject headings
- Anorexia Nervosa, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interoceptive Exposure (IE)Behavioural
Participants are provided with a meal replacement shake of 'unknown' Kcal or macronutrient content and are asked to mindfully observe the sensations (aversive taste, texture, bloating, icky feeling, etc.) and associated emotional states (i.e., disgust) with the empathetic support of parents/therapist in session, without expectation of habituation. Sessions occur on a weekly basis with session one lasting 2 hrs. The remaining 5 sessions last one hour, and participants eat a meal replacement shake over 30-minutes, identical to the first session. All sessions include debriefing and development of IE homework that includes daily practice of IE.
Family Based Therapy-Weight Gain Control (FBT-WG)Behavioural
Participants and families randomized to FBT-WG will receive 6-weeks of FBT treatment for AN. Sessions occur weekly, with the first session lasting two hours and the remaining 5 sessions one hour. FBT is atheoretical in terms of the etiology, but uses parent-enforced contingencies to increase value of eating and decrease the value of food avoidance.
meal replacement shakeDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Interoceptive Exposure (IE) | Experimental | IE is an exposure-based intervention that involves consuming a food in session and tolerating uncomfortable feelings around eating. Receives: Behavioral: Interoceptive Exposure (IE); Dietary Supplement: meal replacement shake |
| Family Based Therapy-Weight Gain Control (FBT-WG) | Active comparator | Family-based therapy uses parent(s) to help modify disordered eating and develop contingencies to motivate eating. Receives: Behavioral: Family Based Therapy-Weight Gain Control (FBT-WG) |
| Healthy Controls (HC) | No intervention | HC participants will only participate in the pre and post-intervention visits and not in the intervention sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI-EMG
Change in the emotional responses from facial muscle movements to food pictures and non-food pictures as measured with the fMRI-EMG.
Measured: Baseline and 6 weeks
Secondary outcomes (4)
KCal Intake
Change in KCal Intake at 6 weeks as compared to baseline. Consumption of a standardized strawberry yogurt shake test meal will be measured in kcal. Participants will be presented with an 83 fluid ounce (2454.60-mL) covered opaque container containing approximately 1500 grams (1.04 kcal per gram, or approximately 1560 kcal) of strawberry yogurt shake. Patients will be informed that the meal consists of a strawberry yogurt shake, but will not be told the amount provided in the container. The instructions will direct participants to consume as much of the shake as they would like and that the meal will serve as their lunch (or dinner) for the day and to avoid touching or manipulating the container in any way.
Measured: Baseline and 6 weeks
Eating Disorder Examination (EDE)
Change in EDE at 6 weeks as compared to baseline. Clinical interview to assess for eating disorder symptomology.
Measured: Baseline and 6 weeks
Clinical Impairment Assessment
Change in assessment at 6 weeks as compared to baseline. The Clinical Impairment Assessment (CIA) is a 16-item self-report measure of the severity of psychosocial impairment due to eating disorder features on the past 28 days. Each item are scored 0, 1, 2, 3 with a higher rating indicating a higher level of impairment, with total score ranging from 0 to 48 with a higher score being indicative of a higher level of psychosocial impairment secondary to eating disorder features.
Measured: Baseline and 6 weeks
Anxiety Sensitivity Index-III
Change in index at 6 weeks as compared to baseline. Self-reported anxiety symptomology
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startNov 2016
- Primary completion29 Jul 2021
- Study completion29 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Weight Eating DisordersStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Tom Hildebrandt, Icahn School of Medicine at Mount Sinai
- Investigators
- Tom Hildebrandt, PsyD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795455
- Sponsor's protocol ID
- GCO 15-0939
- Other IDs
- 1R01MH109639-01A1
- Status last verified
- May 2025
- First submitted
- 19 May 2016
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schulz KP, Sysko R, Fan J, Hildebrandt TB. Interoceptive Exposure Impacts Food-Cue Extinction in Adolescents With Low-Weight Eating Disorders: A Functional Magnetic Resonance Imaging Study. J Am Acad Child Adolesc Psychiatry. 2026 Jan;65(1):66-75. doi: 10.1016/j.jaac.2024.12.013. Epub 2025 Feb 25.
PubMed 40015474Sysko R, Schulz KP, Hildebrandt T. A randomized controlled trial of brief interoceptive exposure and family-based treatment for adolescents with low-weight eating disorders. J Child Psychol Psychiatry. 2026 Jun 17. doi: 10.1111/jcpp.70185. Online ahead of print.
PubMed 42310840Hildebrandt T, Schulz K, Fleysher L, Griffen T, Heywood A, Sysko R. Development of a methodology to combine fMRI and EMG to measure emotional responses in patients with anorexia nervosa. Int J Eat Disord. 2018 Jul;51(7):722-729. doi: 10.1002/eat.22893. Epub 2018 Aug 18.
PubMed 30120839
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reward Systems and Food Avoidance in Adolescents With Low Weight Eating Disorders
- ClinicalTrials.gov ID
- NCT02795455
- Acronym / sponsor ID
- GCO 15-0939
- Conditions
- Low Weight Eating Disorders, Anorexia Nervosa
- Keywords
- Eating Disorders, Food Avoidance, Reward Learning, Reward System, Family-based treatment, interoceptive exposure, insula-amygdala-ventral striatum subcircuits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2016
- Primary completion
- 29 Jul 2021 (actual)
- Study completion
- 29 Jul 2021 (actual)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers plan to explore brain networks involved in emotion processing and learning using a brain scan and test meals. One core feature of Anorexia Nervosa (AN) is eating a small number of high-calorie or high-fat foods. By studying why individuals with AN are disgusted by food or other eating situations, the researchers will be able to understand more about the neurobiological pathways that lead to restricting food intake and food avoidance. This study also aims to find whether one of two short-term interventions (Interoceptive Exposure (IE); Family-Based Therapy (FBT)) affects connections in the brain and if the treatments affect food avoidance. IE is an intervention that helps reduce anxiety about eating. FBT is an intervention that motivates patients to eat through working with family to increase the value of eating and decrease the value of avoiding foods.
Detailed description
Anorexia nervosa (AN), a characteristically relentless pursuit of thinness with an intense fear of weight gain despite significantly low body weight, is a serious psychiatric disorder with high rates of morbidity and mortality. Low weight eating disorders (LW-ED), the broader category of eating pathology that includes AN and similar variants, are characterized by a chronic course, poor response to treatment, and food avoidance. Emerging neuroimaging evidence suggests that deficits in insula-amygdala-ventral striatum (IAVS) neurocircuitry contribute to individual variability in aversive and reward learning, and that these brain regions demonstrate abnormal responses to food/eating stimuli. The researchers' pilot data suggest that patients with LW-ED experience difficulty extinguishing food-cue associations in a reversal learning paradigm compared to healthy controls, a difficulty that is related to psychophysiological measures of aversive disgust (not fear). The researchers have also successfully piloted an interoceptive exposure intervention for this population that targets visceral sensitivity and seeks to increase 'top-down' regulation of the IAVS neurocircuit. The proposed project will (a) use novel fMRI-EMG to test the relationship between effective connectivity within amygdala-insula-ventral striatum network and its relationship to psychophysiological and behavioral measures of acute threat and reward learning in 60 adolescents with LWEDs and 30 healthy controls, (b) test the sensitivity of this network to an experimental interoceptive exposure paradigm relative to patients receiving family based therapy for weight restoration using dynamic causal modeling of fMRI-EMG data pre-post experimental conditions, (c) validate this model against objective measures of laboratory and real world eating behavior. The results of this study will help better understand the core neurocircuitry that underlies both threat processing and reward/aversive learning and how this circuit relates to objective behavior. Further, the researchers will determine the modifiability of this neurocircuitry via two distinct behavioral interventions chosen to target different aspects of affective processing and reward learning. These data will be used to inform future clinical interventions targeting aversive/reward learning within this population and dysregulation in insula-amygdala-ventral striatum subcircuits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interoceptive Exposure (IE) | Experimental | Behavioral: Interoceptive Exposure (IE), Dietary Supplement: meal replacement shakeIE is an exposure-based intervention that involves consuming a food in session and tolerating uncomfortable feelings around eating. |
| Family Based Therapy-Weight Gain Control (FBT-WG) | Active comparator | Behavioral: Family Based Therapy-Weight Gain Control (FBT-WG)Family-based therapy uses parent(s) to help modify disordered eating and develop contingencies to motivate eating. |
| Healthy Controls (HC) | No intervention | –HC participants will only participate in the pre and post-intervention visits and not in the intervention sessions. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Females,
- Adolescents ages 12-18,
- Speak English,
- Seeking treatment
- Refusal to maintain greater than minimally low body weight based on BMI for age percentiles and growth trajectories,
Key exclusion criteria (15 listed)
- Current psychotropic medication that would have an effect on performance on behavioral tasks (i.e., anti-anxiety medication),
- Comorbid psychotic or bipolar disorder,
- Active suicidal ideation,
- Major medical illness known to influence eating or weight,
- Current substance dependence,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interoceptive Exposure (IE)Participants are provided with a meal replacement shake of 'unknown' Kcal or macronutrient content and are asked to mindfully observe the sensations (aversive taste, texture, bloating, icky feeling, etc.) and associated emotional states (i.e., disgust) with the empathetic support of parents/therapist in session, without expectation of habituation. Sessions occur on a weekly basis with session one lasting 2 hrs. The remaining 5 sessions last one hour, and participants eat a meal replacement shake over 30-minutes, identical to the first session. All sessions include debriefing and development of IE homework that includes daily practice of IE. | Behavioural | Interoceptive Exposure (IE) |
| Family Based Therapy-Weight Gain Control (FBT-WG)Participants and families randomized to FBT-WG will receive 6-weeks of FBT treatment for AN. Sessions occur weekly, with the first session lasting two hours and the remaining 5 sessions one hour. FBT is atheoretical in terms of the etiology, but uses parent-enforced contingencies to increase value of eating and decrease the value of food avoidance. | Behavioural | Family Based Therapy-Weight Gain Control (FBT-WG) |
| meal replacement shake | Dietary supplement | Interoceptive Exposure (IE) |
Primary outcome
fMRI-EMG
Time frame: Baseline and 6 weeks
Change in the emotional responses from facial muscle movements to food pictures and non-food pictures as measured with the fMRI-EMG.
4 secondary outcomes
KCal Intake
Time frame: Baseline and 6 weeks
Eating Disorder Examination (EDE)
Time frame: Baseline and 6 weeks
Clinical Impairment Assessment
Time frame: Baseline and 6 weeks
Anxiety Sensitivity Index-III
Time frame: Baseline and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Background: PubMed 40015474Schulz KP, Sysko R, Fan J, Hildebrandt TB. Interoceptive Exposure Impacts Food-Cue Extinction in Adolescents With Low-Weight Eating Disorders: A Functional Magnetic Resonance Imaging Study. J Am Acad Child Adolesc Psychiatry. 2026 Jan;65(1):66-75. doi: 10.1016/j.jaac.2024.12.013. Epub 2025 Feb 25.
- Derived from this study: PubMed 42310840Sysko R, Schulz KP, Hildebrandt T. A randomized controlled trial of brief interoceptive exposure and family-based treatment for adolescents with low-weight eating disorders. J Child Psychol Psychiatry. 2026 Jun 17. doi: 10.1111/jcpp.70185. Online ahead of print.
- Derived from this study: PubMed 30120839Hildebrandt T, Schulz K, Fleysher L, Griffen T, Heywood A, Sysko R. Development of a methodology to combine fMRI and EMG to measure emotional responses in patients with anorexia nervosa. Int J Eat Disord. 2018 Jul;51(7):722-729. doi: 10.1002/eat.22893. Epub 2018 Aug 18.
- Individual participant dataSharing planned: No
Related trials for Low Weight Eating Disorders
Recruiting
Efficacy of Non-invasive Vagus Nerve Stimulation for Treatment of Low Weight Eating Disorders
Anorexia Nervosa
Not yet recruiting
Impact of Lifestyle on Health Maintenance: A Randomized Controlled Trial
Metabolic Syndrome, Inactivity/Low Levels of Exercise
Not yet recruitingObservational study
3-Dimensional Optical Scanning to Assess and Monitor Malnutrition in Eating Disorders (3D-ED) Study
Anorexia in Adolescence, Anorexia Nervosa
Recruiting
Interoceptive Exposure for Adolescents With Low Weight Eating Disorders
Anorexia Nervosa
Active, not recruiting
Metacognitive Interpersonal Therapy Across Transdiagnostic Eating Disorders, Including Underweight
Eating Disorders, Maladaptive Personality Trait
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Hildebrandt, PsyD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interoceptive Exposure (IE) and meal replacement shake in people with Low Weight Eating Disorders and Anorexia Nervosa, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI-EMG (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02795455, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.