Nutritional Counseling Based on Self-compassion vs. Diet Approach on Body Dissatisfaction and Disordered Eating
Comparison of Nutritional Counseling Based on Self-compassion vs. Diet Approach on Body Dissatisfaction, Food Restriction, and Disordered Eating in Adult Women
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
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
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
- Hospital de Clinicas de Porto Alegre
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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
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
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Carolina G de Souza, PhD, Hospital de Clinicas de Porto Alegre
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2022-0634
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.