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Completed

NCT Number: NCT06230107

The Effects of Nutritional Intervention in Participants With Eating Disorders.

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.

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Key information

Conditions

Eating Disorders Behavior Behavior, Animal Binge Eating Disorder Associated With Obesity Binge-Eating Disorder Eating Behavior Eating Disorder Feeding Behavior Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tatiana Palotta Minari

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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%)

  4. Weight (kg).

    Time frame: 8 weeks

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

  5. 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.

  6. Waist circumference (cm).

    Time frame: 8 weeks

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

Sponsors and collaborators

Lead sponsor

Sao Jose do Rio Preto Medical School

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Nutritional Therapeutic Intervention in Eating Disorders

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 30, 2024
Registry last updated
Jan 31, 2024

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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