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Active, Not Recruiting

NCT Number: NCT06866301

Active Lifestyle Intervention in Anorexia Nervosa: a Comprehensive Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Anorexia Nervosa Behavior Feeding and Eating Disorders Mental Disorders Motor Activity Personal Satisfaction Psychological Well-Being

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oviedo

Oviedo, Principality of Asturias, 33009, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Progressive resistance exercise

Behavioral

The exercise program will have a duration of 10 weeks. It will be divided in two phases: conditioning phase and training phase. During the conditioning phase (2-3 weeks), participants will learn exercise techniques, work on their interoceptive awareness and perform same exercises at a lower intensity to prepare the muscles for the next phase. In the training phase, the intensity will be moderate starting at approximately 60% of capacity, with a frequency of three days per week and continuous adjustment (progression) based on the participant's improvements. Each session will include a warm-up and cool-down of approximately 10 minutes. The central part of the session will be in the form of a circuit and will include 6 large muscle group exercises using a combination of machine exercises following the PPL (push, pull and legs) model and 3 core strengthening exercises.

Primary outcomes

  1. Change of microRNA profile from baseline to week 12 and week 24

    Time frame: 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

  2. Change of gut microbiota profile from baseline to week 12 and week 24

    Time frame: 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

  3. Change of Eating Disorders Examination Questionnaire (EDE-Q) scores from baseline to week 12 and week 24

    Time frame: 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

  4. Change of muscle strength from baseline to week 12 and week 24

    Time frame: 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).

  5. Change of muscle content from baseline to week 12 and week 24

    Time frame: 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 outcomes

  1. Change of the anthropometric profile from baseline to week 12 and week 24

    Time frame: 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).

  2. Change of fat content from baseline to week 12 and week 24

    Time frame: 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.

  3. Change of functional capacity from baseline to week 12 and week 24

    Time frame: 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).

  4. Change of Physical Activity Levels from baseline to week 12 and week 24

    Time frame: 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.

  5. Change of Beck Depression Inventory 2 (BDI-2) from baseline to week 12 and week 24

    Time frame: 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.

  6. Change of Brief Symptom Inventory (BSI) scores from baseline to week 12 and week 24

    Time frame: 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.

  7. Change of The Short Form-36 Health Survey (SF-36) scores from baseline to week 12 and week 24

    Time frame: 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.

Other outcomes

  1. Change of Exercise Dependence Scale-Revised (EDS-R) scores from baseline to week 12 and week 24

    Time frame: Baseline, week 12 and week 24

    The Exercise Dependence Scale-Revised (EDS-R) is a self-report questionnaire used to assess symptoms of exercise dependence through seven subscales (Tolerance, Withdrawal, Continuance, Lack of Control, Reduction in Other Activities, Time, and Intention Effects). Rated on a 6-point Likert scale (1 indicates "Never", 6 indicates "Always"), higher scores indicate greater severity of exercise dependence symptoms.

  2. Perceptions related to exercise resulted from the intervention after 24 weeks

    Time frame: After 24 weeks

    Perceptions of patients related to exercise are sensitive to lifestyle and educational interventions and are measured through guided interviews. A possible finding is an improved perception after exercise intervention. Interviews are analyzed throughout qualitative methods by categorizing common themes.

Sponsors and collaborators

Lead sponsor

University of Oviedo

Other

Registry information

Official study title

DiANa Project: Uncovering the Relationship Between MircroRNA Expression, Gut Microbiota and Prognosis in Patients with Anorexia Nervosa.

Acronym: DiANa

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2025
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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