The Effects of Nutritional Intervention in Participants With Eating Disorders.

NCT06230107 | Completed

• 1 other identifier: 70217317.4.0000.5415
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Eating Disorders; Binge-Eating Disorder; Binge Eating Disorder Associated With Obesity; Eating Behavior; Eating Disorder

Keywords

eating disorders; binge eating disorder; eating behavior; eating disorder

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• Weight (kg).

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

  8 weeks

• 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

• Waist circumference (cm).

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

  8 weeks

Study Arms (1)

Participants diagnosed with Binge Eating Disorder

EXPERIMENTAL

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

Behavioral: Mindful Eating

Interventions

Mindful Eating BEHAVIORAL

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.

Participants diagnosed with Binge Eating Disorder

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• individuals diagnosed with BED who are available to participate

You may not qualify if:

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

Sponsors & Collaborators

• Sao Jose do Rio Preto Medical School: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Tatiana Palotta Minari

São José do Rio Preto, São Paulo, 15092415, Brazil

Location

MeSH Terms

Conditions

Feeding and Eating Disorders; Binge-Eating Disorder; Feeding Behavior

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior, Animal; Behavior

Study Officials

• Tatiana Palotta Minari, PhD Student

  State Faculty of Medicine in São José do Rio Preto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: quantitative, prospective, longitudinal and experimental

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 30, 2024
• Study Start: October 18, 2023
• Primary Completion: November 15, 2023
• Study Completion: December 15, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact: tatianaminari@gmail.com

Locations

BR (1)