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Clinical Trials/NCT06230107
NCT06230107
Completed
Not Applicable

Nutritional Therapeutic Intervention in Eating Disorders

Sao Jose do Rio Preto Medical School1 site in 1 country82 target enrollmentOctober 18, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Eating Disorders
Sponsor
Sao Jose do Rio Preto Medical School
Enrollment
82
Locations
1
Primary Endpoint
Body Image Dissatisfaction {Body Shape Questionnaire (BSQ) (34 to 204 points)}.
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
October 18, 2023
End Date
December 15, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Sao Jose do Rio Preto Medical School
Responsible Party
Principal Investigator
Principal Investigator

Tatiana Palotta Minari

Principal Investigator

Sao Jose do Rio Preto Medical School

Eligibility Criteria

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

Outcomes

Primary Outcomes

Body Image Dissatisfaction {Body Shape Questionnaire (BSQ) (34 to 204 points)}.

Time Frame: 8 weeks

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).

Waist circumference (cm).

Time Frame: 8 weeks

Evaluate the impact of nutritional intervention on waist circumference (cm) between the 1st and 8th week.

Episodes of Binge Eating {Binge Eating Scale (BES} (0 to 48 points)}.

Time Frame: 8 weeks

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).

Body Mass Index (kg/m²).

Time Frame: 8 weeks

Evaluate the impact of nutritional intervention on Body Mass Index \[Weight(kg)/height(m)²\] between the 1st and 8th week.

Quality of Life {Quality of LifeScale WHOQOL BREF) (0 to 100%)}.

Time Frame: 8 weeks

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%)

Weight (kg).

Time Frame: 8 weeks

Evaluate the impact of nutritional intervention on weight (kg) between the 1st and 8th week.

Study Sites (1)

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