- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06084260
Nutritional Counseling Based on Self-compassion vs. Diet Approach on Body Dissatisfaction and Disordered Eating
October 19, 2023 updated by: Hospital de Clinicas de Porto Alegre
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
76
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alessandra B Ramos
- Phone Number: 5551998191636
- Email: alessandrabehar@gmail.com
Study Contact Backup
- Name: Carolina G de Souza, PhD
- Phone Number: 51992944218
- Email: cgsouza@hcpa.edu.br
Study Locations
-
-
RS
-
Porto Alegre, RS, Brazil, 90035-903
- Recruiting
- Hospital de Clínicas de Porto Alegre
-
Contact:
- Carolina G de Souza, PhD
- Phone Number: 51992944218
- Email: cgsouza@hcpa.edu.br
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Self-compassion group
Group meetings using a self-compassion approach related to body dissatisfaction and eating issues.
|
Weekly meetings using self-compassion techniques to improve body dissatisfaction and eating behavior.
|
Active Comparator: Diet group
Group meetings using a restricted diet approach related to body dissatisfaction and eating issues.
|
Individual diet, with caloric restriction, associated with weekly meetings about eating habits modifications.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and after 8 weeks.
|
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.
|
Baseline and after 8 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-compassion
Time Frame: Baseline and after 8 weeks.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Carolina G de Souza, PhD, Hospital de Clínicas de Porto Alegre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 16, 2023
Primary Completion (Estimated)
December 20, 2024
Study Completion (Estimated)
December 19, 2025
Study Registration Dates
First Submitted
October 10, 2023
First Submitted That Met QC Criteria
October 13, 2023
First Posted (Actual)
October 16, 2023
Study Record Updates
Last Update Posted (Actual)
October 23, 2023
Last Update Submitted That Met QC Criteria
October 19, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2022-0634
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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