The Effects of Nutritional Intervention in Participants With Eating Disorders.

Eating Disorders Clinical Trial

Official title:

Nutritional Therapeutic Intervention in Eating Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06230107
• Other study ID #: 70217317.4.0000.5415
• Status: Completed
• Phase: N/A
• Start date: October 18, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: January 2024
• Source: Sao Jose do Rio Preto Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to evaluate the effects of nutritional intervention in eating disorders. Participants underwent an intervention without a control group over 8 weeks. This study aims to provide the maximization of nutritional rehabilitation and support changes in the construction of food autonomy, through a food and nutritional intervention.

Description:

Analyze the impact of nutritional intervention on changes in dietary habits, episodes of binge eating, body image dissatisfaction, quality of life and anthropometric data (weight, BMI and waist circumference) of participants with BED. This quantitative, prospective, longitudinal and experimental study recruited 82 participants diagnosed with Obesity and BED. The intervention was divided into 8 individual weekly meetings, guided by Mindful eating session, nutritional educational dynamics, cooking workshop, food sensory analysis and applications of questionnaires (Body Image Scale - BSQ; Binge Eating Scale - BES; Quality of Life Scale - WHOQOL BREF). The meetings occurred from October to November 2023.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 15, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• individuals diagnosed with BED who are available to participate

Exclusion Criteria:

• individuals without a diagnosis of BED who are available to participate; who cannot attend meetings; with clinical changes; who have difficulty answering the questionnaires

Related Conditions & MeSH terms

• Binge Eating Disorder Associated With Obesity
• Binge-Eating Disorder
• Bulimia
• Eating Behavior
• Eating Disorder
• Eating Disorders
• Feeding and Eating Disorders

Intervention

Behavioral:
• Mindful Eating
Analyze the impact of Mindful Eating on changes in dietary habits, episodes of binge eating, body image dissatisfaction, quality of life and anthropometric data (weight, BMI and waist circumference) in Participants with obesity and BED.

Locations

Country	Name	City	State
Brazil	Tatiana Palotta Minari	São José do Rio Preto	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Sao Jose do Rio Preto Medical School	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Episodes of Binge Eating {Binge Eating Scale (BES} (0 to 48 points)}.	Evaluate the impact of nutritional intervention on the variation in the number of binge eating episodes between the 1st and 8th week. Application of the 'Binge Eating Scale (BES) which quantifies the severity of Binge Eating, cognitions, feelings, and behaviors related to the Binge Eating episode, consisting of 16 items in a 4-point Likert format and 62 statements from which the one that best represents the individual's response. Each statement corresponds to a number of points from 0 to 3, ranging from the absence ("0") to the maximum severity ("3") of Binge Eating. The final score is the result of the sum of the points for each item. According to the classification, individuals with a score less than or equal to 17 are classified as "No Binge Eating". Individuals with a score between 18 and 26 are considered to have "Moderate Binge Eating" and those with a score greater than or equal to 27 are classified as "Severe Binge Eating" (minimum 0 points and maximum 48 points).	8 weeks
Primary	Body Image Dissatisfaction {Body Shape Questionnaire (BSQ) (34 to 204 points)}.	Evaluate the impact of nutritional intervention on the level of body image dissatisfaction between the 1st and 8th week. Application of the Body Image Scale (BSQ) who was measures satisfaction and concern with body shape, consisting of 34 items on a 6-point Likert scale. According to the classification, to be classified as "satisfied with your body shape" is necessary score <111 (minimum 34 points and maximum 204 points).	8 weeks
Primary	Quality of Life {Quality of LifeScale WHOQOL BREF) (0 to 100%)}.	Evaluate the impact of nutritional intervention on quality of life between the 1st and 8th week. Application of the Quality of Life Scale WHOQOL BREF who was evaluates the quality of life of the patient, comprising 26 Likert-scale questions. This ques-tionnaire is divided into 4 domains - physical, psychological, social, and environmental. According to the classification, the higher the percentage, the better the quality of life (0-100%)	8 weeks
Primary	Weight (kg).	Evaluate the impact of nutritional intervention on weight (kg) between the 1st and 8th week.	8 weeks
Primary	Body Mass Index (kg/m²).	Evaluate the impact of nutritional intervention on Body Mass Index [Weight(kg)/height(m)²] between the 1st and 8th week.	8 weeks
Primary	Waist circumference (cm).	Evaluate the impact of nutritional intervention on waist circumference (cm) between the 1st and 8th week.	8 weeks