Body DissatisfactionNCT06084260
Nutritional Counseling Based on Self-compassion vs. Diet Approach on Body Dissatisfaction and Disordered Eating
A study testing Diet group and Self-compassion group in people with Body Dissatisfaction and Disordered Eating, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 25 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Dissatisfaction, Disordered Eating
- What is being tested?
- Diet group and Self-compassion group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Aug 2023to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 25 and 59 years;
- access to cell phone and communication apps.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Comparison of Nutritional Counseling Based on Self-compassion vs. Diet Approach on Body Dissatisfaction, Food Restriction, and Disordered Eating in Adult Women
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.
Read the detailed 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.
- Conditions
- Body Dissatisfaction, Disordered Eating
- Being tested
- Diet group, Self-compassion group
- Keywords
- body image, eating behaviour, diet, self-compassion
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet groupDietary supplement
Individual diet, with caloric restriction, associated with weekly meetings about eating habits modifications.
Self-compassion groupBehavioural
Weekly meetings using self-compassion techniques to improve body dissatisfaction and eating behavior.
| Study group | Role | What they receive |
|---|---|---|
| Self-compassion group | Active comparator | Group meetings using a self-compassion approach related to body dissatisfaction and eating issues. Receives: Behavioral: Self-compassion group |
| Diet group | Active comparator | Group meetings using a restricted diet approach related to body dissatisfaction and eating issues. Receives: Dietary Supplement: Diet group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and after 8 weeks.
Secondary outcomes (1)
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.
Measured: Baseline and after 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start16 Aug 2023
- Primary completion20 Dec 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body DissatisfactionStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carolina G de Souza, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06084260
- Sponsor's protocol ID
- 2022-0634
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2023
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40455797
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Nutritional Counseling Based on Self-compassion vs. Diet Approach on Body Dissatisfaction, Food Restriction, and Disordered Eating in Adult Women
- ClinicalTrials.gov ID
- NCT06084260
- Acronym / sponsor ID
- 2022-0634
- Conditions
- Body Dissatisfaction, Disordered Eating
- Keywords
- body image, eating behaviour, diet, self-compassion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-compassion group | Active comparator | Behavioral: Self-compassion groupGroup meetings using a self-compassion approach related to body dissatisfaction and eating issues. |
| Diet group | Active comparator | Dietary Supplement: Diet groupGroup meetings using a restricted diet approach related to body dissatisfaction and eating issues. |
Who may qualify
- Ages
- 25 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age between 25 and 59 years;
- access to cell phone and communication apps.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet groupIndividual diet, with caloric restriction, associated with weekly meetings about eating habits modifications. | Dietary supplement | Diet group |
| Self-compassion groupWeekly meetings using self-compassion techniques to improve body dissatisfaction and eating behavior. | Behavioural | Self-compassion group |
Primary outcome
Body dissatisfaction
Time frame: Baseline and after 8 weeks.
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.
Disordered eating
Time frame: Baseline and after 8 weeks.
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.
1 secondary outcome
Self-compassion
Time frame: Baseline and after 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Derived from this study: PubMed 40455797Ramos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolina G de Souza, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet group and Self-compassion group in people with Body Dissatisfaction and Disordered Eating, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body dissatisfaction (time frame: Baseline and after 8 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06084260, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.