Active Lifestyle Intervention in Anorexia Nervosa: a Comprehensive Study

Not Applicable

Active, not recruiting

• Conditions: Anorexia Nervosa

• Registration Number: NCT06866301
• Lead Sponsor: University of Oviedo

Brief Summary

The goal of this study is to perform a comprehensive analysis of varied health markers and analyze the impact of lifestyle interventions on the prognosis of anorexia nervosa (AN) patients. In addition, this study aims to determine if biomarker analysis can be used as clinical outcomes for disease prognosis long-term and support individualized treatment strategies in female patients with AN during the post-hospitalization phase.

The main questions it aims to answer are:

* What are the miRs and microbiota profiles associated with AN, and how are they linked to other clinical markers?

* How does a lifestyle intervention (exercise with nutritional support) affect biomarkers and clinical markers during the first three months after hospitalization?

* What are the dynamics and associations of biomarkers, including gut microbiota, and how do they relate to critical events during the six months after hospitalization?

* What is the perceived effect of participating in a healthy lifestyle program for patients, families, and professionals involved in the care of these patients?

Participants will:

* Undergo analysis of biomarkers and gut microbiota associated with AN.

* Participate in a lifestyle intervention program involving exercise during the first three months post-hospitalization.

* Provide samples for biomarker and gut microbiota mapping over a six-month period.

* Share feedback on their perceived experience in the lifestyle program through interviews or surveys.

Researchers will compare biomarker and gut microbiota and the effects of the intervention to determine if a lifestyle exercise intervention can lead to better outcomes, and analyze its potential to individualized care strategies.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-25
• Status Verified: 2025-01
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10
• Primary Completion: 2025-07
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

A) Patients:

• Patients with a diagnosis of AN (any subtype)
• BMI >14kg/m2
• Under treatment at the Regional Eating Disorders Unit at the Area IV and V of the Principality of Asturias
• After acute treatment (total or partial hospitalization or other acute treatment regime following the recommendation of the medical team)

B) Healthy Controls:

• Meet the physical activity recommendations of the World Health Organization for the age group and sex.

Exclusion Criteria

A) Patients:

• Contraindications to perform the evaluations proposed in this project
• Unmanaged dysfunctional or compulsive exercise
• Other criteria that, in the opinion of the medical team, prioritize the patient's health (i.e., psychological instability, substance abuse) .

B) Healthy Controls:

• Suffer from metabolic, pulmonary or cardiovascular disease
• Suffer from serious organic disease
• Taking prescribed medications while participating in the project
• Have contraindications to perform the proposed assessments or intervention.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of microRNA profile from baseline to week 12 and week 24	Baseline, week 12 and week 24	microRNAs are epigenetic markers that are sensitive to lifestyle interventions. A possible change is an improved profile after exercise intervention. microRNAs are measured in reads per million
Change of gut microbiota profile from baseline to week 12 and week 24	Baseline, week 12 and week 24	Gut microbiota is a group of bacteria that are sensitive to lifestyle interventions, stress and other environmental factors. A possible change is an improved profile after exercise intervention. Microbiota is measured in reads per million
Change of Eating Disorders Examination Questionnaire (EDE-Q) scores from baseline to week 12 and week 24	Baseline, week 12 and week 24	The EDE-Q provides a global score and four subscale scores (Restraint, Eating Concern, Shape Concern, and Weight Concern) derived from a 7-point Likert scale, where 0 indicates no symptoms or concerns and 6 indicates the most severe symptoms or concerns. Higher scores represent greater severity of eating disorder pathology
Change of muscle strength from baseline to week 12 and week 24	Baseline, week 12 and week 24	Muscle strength is a physical fitness marker that is sensitive to lifestyle interventions. A possible change is an improved muscle strength after exercise intervention. Strength is measured in kilograms, Newtons, Watts, velocity (meters/second) or time (seconds).
Change of muscle content from baseline to week 12 and week 24	Baseline, week 12 and week 24	Muscle content is a marker of health that is sensitive to lifestyle interventions and is measured with BioImpedance Analysis. A possible change is an improved muscle content after exercise intervention. Muscle content is measured in Kilograms or squared centimeters.

Secondary Outcome Measures

Name	Time	Method
Change of the anthropometric profile from baseline to week 12 and week 24	Baseline, week 12 and week 24	Anthropometric measurements server as a marker of body composition which are sensitive to lifestyle interventions. A possible change is an improved anthropometric profile after exercise intervention. Anthropometric variables are measured in kilograms (body weight), meters (height), centimeters (circumferences), millimeters (skinfolds).
Change of fat content from baseline to week 12 and week 24	Baseline, week 12 and week 24	Fat content is a health marker that is sensitive to lifestyle interventions. A possible change is an improved fat content after exercise intervention and is measured with BioImpedance Analysis. Fat content is measured in kilograms or millimeters.
Change of functional capacity from baseline to week 12 and week 24	Baseline, week 12 and week 24	Functional capacity is a marker that indicates the capacity of the body to supply oxygen and nutrients to the muscles for energy production. It is sensitive to lifestyle interventions. A possible change is an improved functional capacity after exercise intervention. Functional capacity is measured in milliliters per kilogram per minute, Liters per minute, meters per second, beats per minute, or time (minutes).
Change of Physical Activity Levels from baseline to week 12 and week 24	Baseline, week 12 and week 24	Physical Activity Levels are markers of health and well-being sensitive to lifestyle interventions. A possible change is an improved physical activity level profile after exercise intervention. Physical activity levels are measured in minutes/day, kcals, counts or % of time during the day/week.
Change of Beck Depression Inventory 2 (BDI-2) from baseline to week 12 and week 24	Baseline, week 12 and week 24	The Beck Depression Inventory-2 (BDI-2) is a self-report questionnaire designed to assess the severity of depressive symptoms. Each item is rated on a 4-point scale ranging from 0 to 3, where 0 indicates no symptom severity and 3 indicates the most severe level of the symptom. The total score ranges from 0 to 63, with higher scores indicating greater severity of depressive symptoms.
Change of Brief Symptom Inventory (BSI) scores from baseline to week 12 and week 24	Baseline, week 12 and week 24	The Brief Symptom Inventory (BSI) is a self-report questionnaire designed to assess distress across three symptom dimensions (depression, anxiety, and somatization) and a global severity index. Higher scores reflect greater levels of distress or severity of symptoms.
Change of The Short Form-36 Health Survey (SF-36) scores from baseline to week 12 and week 24	Baseline, week 12 and week 24	The Short Form-36 Health Survey (SF-36) is a self-report questionnaire designed to measure health-related quality of life across eight domains (Physical Functioning, Role Limitations due to Physical Health, Role Limitations due to Emotional Problems, Energy/Fatigue, Emotional Well-being, Social Functioning, Pain, and General Health). Scores for each domain, as well as a physical and mental component summary score, are derived on a scale from 0 to 100, where 0 indicates the worst possible health or functioning and 100 indicates the best possible health or functioning. Higher scores reflect better health and quality of life.

Trial Locations

Locations (1)

University of Oviedo; 🇪🇸 Oviedo, Asturias, Spain