Active Lifestyle Intervention in Anorexia Nervosa: a Comprehensive Study (DiANa)

University of Oviedo

Status: Active, not recruiting

Conditions: Anorexia Nervosa

Treatments: Behavioral: Progressive Resistance Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06866301

SV-PA-21-AYUD/2021/58376

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 3 patient groups

AN-Intervention

Experimental group

Description:

Patient enrolled in the exercise intervention group

Treatment:

Behavioral: Progressive Resistance Exercise

AN-Control

No Intervention group

Description:

Patient enrolled in the non-exercise group

H-Control

No Intervention group

Description:

Healthy controls in the non-exercise group