Understanding how exercise affects young women with eating disorders
Characterizing Acute Exercise Response in Restrictive Eating Disorders
This study is trying to see how exercise affects young women with eating disorders to help improve their treatment outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 16 Years to 25 Years |
| Sex | Female |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 2 sites (San Francisco, California and 1 other locations) |
| Trial ID | NCT06213883 on ClinicalTrials.gov |
What this trial studies
This study investigates the cognitive, emotional, and biological responses to acute exercise in adolescent and young adult females with eating disorders (EDs). It aims to characterize the driven exercise (DEx) symptom, which is prevalent in this population and negatively impacts treatment outcomes. By recruiting participants with and without EDs, the study will explore the relationship between exercise responses and free-living activity, providing foundational data to inform future treatment strategies. The research is conducted at two sites, focusing on improving understanding of DEx to enhance clinical outcomes for individuals with EDs.
Who should consider this trial
Good fit: Ideal candidates are biological females aged 16-25 who meet the criteria for restrictive-spectrum eating disorders and are medically stable.
Not a fit: Patients with severe medical conditions that preclude exercise or those with certain eating disorder characteristics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more targeted and effective treatments for young women suffering from eating disorders.
How similar studies have performed: While there is existing research on eating disorders, this specific approach to understanding exercise responses in this population is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 16-25 * ED participants must meet full criteria for DSM-5 restrictive-spectrum eating disorders characterized by weight and shape concern, I.e., anorexia nervosa (AN); mild, moderate, or in partial remission), atypical AN, and OSFED -AN type only) * ED participants must be medically stable, and suitable for outpatient treatment * Biological Females, Assigned Female at birth * English Speaking Exclusion Criteria: * Those with a medical condition that precludes exercise (e.g., severe asthma) will be excluded for any contraindications * Biological Males, Assigned Male at birth * BMI less than 16 (over 18 years) or less than 75% expected body weight (under 18 years) * Reported intake on Eating Disorder Examination \<1000kcal daily * Current purging \>1x per day * Current regular episodes of objective binge eating (\>1x/wk) * Current self-report of loss-of control eating per the Eating Disorders Examination Interview * ED related hospitalization, partial hospitalization, or residential treatment in the past month * Any endorsed medical concerns related to physical activity (as probed in the phone screening questions regarding cardiovascular, pulmonary, or metabolic disease). * Major medical disorders (e.g., cancer, AIDS) * Physical discomfort or difficulty with blood draws * Psychotic disorders * Intellectual disabilities * Developmental disorders * Active substance use disorder * Current suicidal risk per the Ask Suicide Screening Questionnaire * Pregnancy * Psychiatric medications that have not been stable for at least 4 weeks * Acute sedatives / pain killers (e.g., benzodiazepines, opioids) and prescription stimulants (e.g., methylphenidate, amphetamines) are not permitted for the full day prior to the laboratory session. The noted short-term medication holds only apply to subjects taking the noted medications in cases used to treat ADHD or other psychiatric conditions * Resting heart rate \<50 beats per minute (assessed at screening visit) * Low blood pressure (\<90/60), (assessed at screening visit) * Daily cannabis use * History of light headedness or fainting during blood draws or physical activity * History of chest pain during physical activity * Bone, joint, cardiac, pulmonary, metabolic, or other medical conditions that may be worsened by physical activity (e.g., COPD, diabetes, hypertension) that are not currently addressed via medication or lifestyle change. * Physical disabilities that prohibit task performance (such as blindness or deafness) * Any other condition that the investigator believes might put the participant at risk for negative outcomes * Individuals with a restrictive eating disorder presentation that does not include weight and shape concern (ARFID) or that has primary binge eating (bulimia nervosa) * Indication of health risk associated with exercise on the Physical Activity Readiness Questionnaire
Where this trial is running
San Francisco, California and 1 other locations
- University of California San Francisco — San Francisco, California, United States (Recruiting)
- University of Wisconsin-Madison — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Katherine Schaumberg, PhD
- Email: kschaumberg@wisc.edu
- Phone: 919-244-9415
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.