Nutritional Counseling Based on Self-compassion vs. Diet Approach on Body Dissatisfaction and Disordered Eating

Disordered Eating Clinical Trial

Official title:

Comparison of Nutritional Counseling Based on Self-compassion vs. Diet Approach on Body Dissatisfaction, Food Restriction, and Disordered Eating in Adult Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06084260
• Other study ID #: 2022-0634
• Status: Recruiting
• Phase: N/A
• Start date: August 16, 2023
• Est. completion date: December 19, 2025

Study information

• Verified date: October 2023
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Alessandra B Ramos
• Phone: 5551998191636
• Email: alessandrabehar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Current evidence has shown that the accepted standard of beauty, where women must be skinny, has increased body dissatisfaction and disordered eating. In order to deal with body dissatisfaction, the practice of restrictive diets - called the diet approach - becomes very often, although it can reinforce disordered eating and has questionable effects on body dissatisfaction. Self-compassion is an approach that proposes a kind and gentle look at body image issues and eating problems, which can be an alternative tool to deal with them. So, this study aims to compare a nutritional approach based on self-compassion techniques x a diet approach on dissatisfaction with body image, food restriction, and disordered eating in women who feel dissatisfied with their bodies.

Description:

A randomized clinical trial will be conducted with adult women randomly allocated into two groups - self-compassion (n=38) or diet approach (n=38) - that will follow over eight weeks. Each group will have weekly meetings of 1 hour, working on different subjects related to self-compassion or dietary choices each week, according to each group. The study outcomes are body dissatisfaction, disordered eating, and self-compassion levels, measured through validated questionnaires. Data will be analyzed using Statistical Package for Social Science for Windows software, and differences between the two groups will be evaluated by the Student's T-test or the Mann-Whitney U test, according to sample distribution. The Chi-square test will analyze the associations between the type of approach and all measured outcomes. Significant differences will be considered when the P value <0.05. As a result, the investigators expect that self-compassion will improve body dissatisfaction and attenuate disordered eating more than the diet approach.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: December 19, 2025
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 59 Years

Eligibility

Inclusion Criteria:

• age between 25 and 59 years;
• access to cell phone and communication apps.

Exclusion Criteria:

• diagnosis of depression, mood disorders (anxiety, bipolar, borderline), eating disorders, or a history of suicidal ideation;
• diagnosis of non-communicable diseases such as diabetes, kidney disease, cardiovascular or neurological diseases.

Related Conditions & MeSH terms

• Body Dissatisfaction
• Disordered Eating

Intervention

Dietary Supplement:
• Diet group
Individual diet, with caloric restriction, associated with weekly meetings about eating habits modifications.

Behavioral:
• Self-compassion group
Weekly meetings using self-compassion techniques to improve body dissatisfaction and eating behavior.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body dissatisfaction	Dissatisfaction with body image will be assessed using the Body Shape Questionnaire.(BSQ) to identify concerns about body shape and self-deprecation related to physical shape.It has 34 questions related to body image, labeled from 1 to 6, with 1-never, 2-rarely, 3-Sometimes, 4-Frequently, 5-Very often, and 6-Always. The result is obtained by adding all the scores. The minimum score obtained is 34 points, and the maximum is 204. A rating below 80 points considers that the individual has no dissatisfaction; between 80 and 110, there is mild dissatisfaction; between 111 and 140, moderate dissatisfaction; and more than 140, severe dissatisfaction.	Baseline and after 8 weeks.
Primary	Disordered eating	Disordered eating will be measured using The three-factor eating questionnaire - R21 (TFEQ-R21), where three dimensions of eating behavior are evaluated: cognitive restriction, uncontrolled eating, and emotional eating. The higher the score obtained, the more dysfunctional the behavior. A rating below 80 points considers that the individual has no dissatisfaction; between 80 and 110, there is mild dissatisfaction; between 111 and 140, moderate; and more than 140, severe dissatisfaction.	Baseline and after 8 weeks.
Secondary	Self-compassion	This outcome will be evaluated through the Self-compassion scale, developed to measure self-compassion in three components: self-judgment versus self-kindness, sense of isolation versus common humanity, and overidentification versus mindfulness.The items are grouped into six subscales: Self-kindness (items 5, 12, 19, 23, 26); Self-judgment (items 1, 8, 11, 16, 21); Common Humanity (items 3, 7, 10, 15); Insulation (items 4, 13, 18, 25); Mindfulness (items 9, 14, 17, 22) and Over-identification (items 2, 6, 20, 24). Each item is rated on a 5-point Likert scale (1 = Almost never; 5 = Almost always). The total score is obtained by adding the scores for all 21 items. Higher scores mean more self-compassion.	Baseline and after 8 weeks.