NCT06084260

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

March 6, 2026

Status Verified

October 1, 2024

Enrollment Period

2.3 years

First QC Date

October 10, 2023

Last Update Submit

March 5, 2026

Conditions

Keywords

body imageeating behaviourdietself-compassion

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (1)

  • Self-compassion

    Baseline and after 8 weeks.

Study Arms (2)

Self-compassion group

ACTIVE COMPARATOR

Group meetings using a self-compassion approach related to body dissatisfaction and eating issues.

Behavioral: Self-compassion group

Diet group

ACTIVE COMPARATOR

Group meetings using a restricted diet approach related to body dissatisfaction and eating issues.

Dietary Supplement: Diet group

Interventions

Diet groupDIETARY_SUPPLEMENT

Individual diet, with caloric restriction, associated with weekly meetings about eating habits modifications.

Diet group

Weekly meetings using self-compassion techniques to improve body dissatisfaction and eating behavior.

Self-compassion group

Eligibility Criteria

Age25 Years - 59 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (1)

  • Ramos AB, da Silva VS, Cardoso DV, de Souza CG. Nutritional approach based in self-compassion versus energy-restricted diet approach in body dissatisfaction and disordered eating in adult women: a protocol for randomized clinical trial. PLoS One. 2025 Jun 2;20(5):e0324030. doi: 10.1371/journal.pone.0324030. eCollection 2025.

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Carolina G de Souza, PhD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2023

First Posted

October 16, 2023

Study Start

August 16, 2023

Primary Completion

December 20, 2025

Study Completion

December 20, 2025

Last Updated

March 6, 2026

Record last verified: 2024-10

Locations