AN/BN Risk Factors Study

NCT05133037 | Active Not Recruiting FDA Device

• 1 other identifier: 61869
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Across the United States, thousands of children and adolescents suffer from eating disorders. Among young women alone, an estimated 2 to 4 percent are dealing with anorexia nervosa. Anorexia nervosa also has the highest mortality rate of any psychiatric disorder and produces a six-fold increased risk for death. Unfortunately, study shows that current treatments are only successful with 25 percent of patients and no eating disorder prevention program has been found to reduce future onset of anorexia nervosa. The goal of this study is to conduct a highly innovative pilot study that will identify risk factors that predict future onset of anorexia nervosa and investigate how the risk processes for anorexia nervosa are different from the risk processes for bulimia nervosa. The proposed pilot study will:

• Compare 30 healthy adolescent girls at high risk for anorexia nervosa to 30 healthy adolescent girls at high risk for bulimia nervosa, and 30 healthy adolescent girls at low risk for eating disorder in an effort to document risk processes that are present in early adolescence before anorexia nervosa typically emerges.
• Test whether elevations in the hypothesized risk factors predict future onset of anorexia nervosa over a four-year follow-up.

Conditions

Eating Disorders

Outcome Measures

Primary Outcomes (6)

• Change from Baseline in Diagnosis of Anorexia Nervosa or Bulimia Nervosa follow-up

  Participants will complete the Eating Disorder Diagnostic Interview, administered by a trained interviewer, assessing for Anorexia Nervosa and Bulimia Nervosa.

  baseline, 6-months, 1-year, 2-year, 3-year, 4-year follow-up

• Baseline Brain Reward Region Response to tastes, anticipated tastes, and images of high calorie foods predictive power

  Adolescents will complete an fMRI food image task where they are shown 20 images of high-calorie foods and 20 images of water. Participants are asked to think about tasting the food or water, respectively. Participants will also complete an fMRI task in which they are alternatively administered a chocolate milkshake and tasteless solution. The investigators will test to see whether baseline brain reward region response predicts future onset of Anorexia Nervosa or Bulimia Nervosa.

  baseline

• Baseline Brain Inhibitory Control and Inhibitory Response to tastes, anticipated tastes, and images of high calorie foods predictive power

  Adolescents complete a food go/no-go fMRI task adapted from Batterinket al., 2010 that activates prefrontal inhibitory regions and then an adapted version of the delay discounting of food paradigm from Sellitto et al. (2010) outside the scanner. The investigators will test to see whether baseline brain inhibitory control and inhibitory response predicts future onset of Anorexia Nervosa or Bulimia Nervosa.

  baseline

• Baseline Brain Reward Region Responsivity to Images of the Thin Beauty Ideal predictive power

  Adolescents complete an fMRI paradigm in which they are shown images of thin, average-weight, and overweight models and asked to think about the attractive level of each model. The investigators will test whether baseline brain reward region responsivity predicts future onset of Anorexia Nervosa or Bulimia Nervosa.

  baseline

• Baseline Overvaluation of Weight and Shape Predictive Power

  Adolescents will complete the eight-item Thin-Ideal Internalization scale with a response scale of 1 = strongly agree to 5 = strongly disagree. The investigators will test to see whether baseline overvaluation of weight and shape predicts future onset of Anorexia Nervosa or Bulimia Nervosa.

  baseline

• Baseline Fear of Becoming Fat Predictive

  Ten items from the Fear of Becoming Fat Scale will assess fear of becoming fat with a response scale of 1 = very untrue to 4 = very true. The investigators will test whether baseline fear of becoming fat predicts future onset of Anorexia Nervosa and Bulimia Nervosa.

  baseline

Secondary Outcomes (5)

• Baseline differences between cohorts for Brain Reward Region Response to tastes, anticipated tastes, and images of high calorie foods

  baseline

• Baseline differences between cohorts for differences between cohorts for Brain Inhibitory Control and Inhibitory Response to tastes, anticipated tastes, and images of high calorie foods

  baseline

• Baseline differences between cohorts for Brain Reward Region Responsivity to Images of the Thin Beauty Ideal

  baseline

• Baseline differences between cohorts for Overvaluation of Weight and Shape

  baseline

• Baseline differences between cohorts for Fear of Becoming Fat

  baseline

Study Arms (1)

Adolescent girls between 12-16 years old

Parental history of eating pathology or no parental history of eating pathology

Device: GE MR Scanner

Interventions

GE MR Scanner DEVICE

3T GE MR 750 systems MR scanner Scanners run compatible software so pulse sequences and reconstructions can easily be supported on all systems. Reconstruction servers are networked to all scanners for reconstruction and data archiving. 3T scanner is equipped with state-of-the-art gradient systems (at least 40 mT/m Gradients / 150 mT/m/ms slew rates) and 16 or more receive channels. 3T scanner includes an assortment of RF coils including quadrature and phased-array coils designed to image brain, spine, neurovascular, torso, pelvis, cardiac, knee, foot/ankle, and hand/wrist. 3T system has several sizes of 16-channel "wrap" coils that are excellent for scans using parallel imaging.

Adolescent girls between 12-16 years old

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

You may qualify if:

• Female
• Ages 12 - 16
• Must have biological parental history of AN or BN, or no history of psychiatric diagnoses

You may not qualify if:

• Current diagnosis of an Eating Disorder;
• Symptoms of major psychiatric disorders (substance use disorders, conduct disorder, attention deficit hyperactive disorder, major depression, bipolar disorder, panic disorder, agoraphobia, generalized anxiety disorder);
• Serious medical conditions (diabetes, brain injury, cancer);
• Body Mass Index (BMI) \<17.5;
• Any contraindications for MRI (e.g. metal objects/implants in body, irremovable body piercings, tattoos or braces, medications that interfere with MRI, history of head injury with loss of consciousness, phobia that wouldn't allow them to complete the MRI);
• Current regular psychoactive drug use;
• Relevant food allergies;
• Not in age range

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Eric Stice, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: November 24, 2021
• Study Start: November 23, 2021
• Primary Completion: June 6, 2025
• Study Completion (Estimated): May 26, 2029
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)