Eating DisorderPITCANCT03667183

Pilates Program in Female Adolescent With Eating Disorders

A study testing Pilates in people with Eating Disorder and Female Adolescents, run by Universidad Pablo de Olavide.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 10 to 17 years, women only
Conditions the study is for: Eating Disorder, Female Adolescents
What is being tested?: Pilates
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: No sites listed yet
Study dates: Jan 2016to Oct 2017
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 10 to 17 years
Women only
No healthy volunteers
Child

Who may be able to join

1) clinical diagnosis of EDs in the aforementioned hospital;
2) aged from 10 to 17 years old;
3) written informed consent by the patients and their legal guardians

Who cannot join

1) have other diagnoses of mental illness or
2) consumption of narcotic toxins

About this study

Official title: Levels of Body Composition, Energy Expenditure, Physical Fitness and Quality of Life in Adolescents With Eating Disorders: Effect of a Pilates Program

Physical exercise helps patients with eating disorders by improving their physical fitness, quality of life and other specific variables of this pathology. Pilates has a beneficial effect both physically and mentally on healthy population and other diseases. In patients with eating disorder, Pilates will improve psychic aspects and their physical condition. For all these reasons, the affectation of psychological symptoms will decrease and the quality of life will improve.

Conditions: Eating Disorder, Female Adolescents
Being tested: Pilates
Medical subject headings: Feeding and Eating Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PilatesOther
Specific postures in movement according to Pilates guidelines.

Study groups in NCT03667183
Study group	Role	What they receive
Pilates Group	Experimental	Female adolescents with eating disorders who receive Pilates for 10 weeks. Receives: Other: Pilates

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in psychopathology - Eating Disorder Inventory-3 (EDI-3).
EDI-3 (Garner, 2004) is a self-report questionnaire that assesses the presence of eating disorders. The EDI-3 is composed of 91 items, organized into 12 main scales: 3 specific scales of eating behavior disorders (Drive for Thinness, DT; Bulimia, B; Body Dissatisfaction, BD) and 9 general psychological scales that are highly relevant, but not specific to eating disorders (Low Self-Esteem, LSE; Personal Alienation, PA; Interpersonal Insecurity, II; Interpersonal Alienation, IA; Interoceptive Deficits, ID; Emotional Dysregulation, ED; Perfectionism, P; Asceticism, A; Maturity Fears, MF). It also provides 6 composite scores: a specific one of the ED and 5 indices of integrative psychological constructs. The format of six-point Likert-scale responses: always, usually, often, sometimes, rarely or never. The score is between 0 and 4 points. The higher the score, the greater the disorder.
Measured: 3 times (week 0, week 10, week 20).
Changes in energy expenditure - SenseWear Mini (SWM).
SenseWear Mini is a multi-sensor activity monitor that combines tri-axial accelerometry with physiological measurements (skin temperature, heat flux and galvanic skin response) for the estimation of several activity parameters. The information of the different sensors, together with the personal characteristics of the participant (sex, age, height, body weight and the use of hands) is processed through proprietary algorithms of the SenseWear software to estimate the energy expenditure, intensity of physical activity and the number of steps on a minute-by-minute basis.
Measured: 3 times (week 0, week 10, week 20).
Changes in body composition - InBody 770 (Body Composition Analyzer).
InBody 770 (Inbody Co., LTD, Seoul, Korea) to measure body composition through bioelectrical impedance analysis (BIA). Parameters evaluated: Weight (kg); Total Body Water (L); Protein (kg); Minerals (kg); Body Fat Mass (kg); Soft Lean Mass (kg); Fat Free Mass (kg); Skeletal Muscle Mass (kg); Body Mass Index (kg/m2); Percent Body Fat (%); Bone Mineral Contect (kg).
Measured: 3 times (week 0, week 10, week 20).
Changes in physical fitness - ALPHA-Fitness Battery.
ALPHA-Fitness Battery (Assessing Levels of Physical Activity and Fitness) was developed to provide a set of valid, reliable, safe and feasible field tests, in order to assess the physical fitness related to health in children and adolescents, and thus be used in a consensual manner in the Public Health system of the different member states of the European Union. There are three versions of the ALPHA-Fitness battery slightly different depending on the time available for the administration of the tests. We used the extended ALPHA-Fitness Battery. This version of the battery includes handgrip strength, standing broad jump, 4x10 m shuttle run test and 20 m shuttle run test (Ruiz et al., 2011).
Measured: 3 times (week 0, week 10, week 20).
Changes in body perception - The Contour Drawing Rating Scale (CDRS).
The Contour Drawing Rating Scale (CDRS) (Thompson \& Gray, 1995) is a scale that evaluates the alterations of the body image. This instrument is a graphic scale, self-administered application, composed of nine female figures views from the front. The person is asked to indicate which figure represents their current body image (perceived body image) and what figure they would like to have (desired body image). The discrepancy between these two classifications represents a measure of body dissatisfaction. The degree of discrepancy varied between -8 and -1 for those who desire a thinner form and between 1 and 8 for those who desire a larger form. A score of 0 was interpreted as satisfaction with body image (Dion et al., 2015). On the other hand, the body image perception index is determined by the following formula: (Estimated size / Actual size) x 100, which would indicate over-estimation when the scores are greater than 100 and underestimation when they are less than 100.
Measured: 3 times (week 0, week 10, week 20).
Changes in the quality of life - KIDSCREEN-27.
KIDSCREEN-27 is a self-administered questionnaire that assesses the health and subjective well-being of children and adolescents (between the ages of 8 and 18) (Ravens-Sieberer et al., 2007). This questionnaire is composed of five dimensions on the Rasch scale: physical well-being, psychological well-being, autonomy and parent relation, peers and social support and school environment. The responses were evaluated and analyzed according to standard algorithms. The recommended syntax steps were performed, including the transformation of Rasch person parameter estimates into Z values, obtaining scale scores as T values with mean scores (± SD) of 50 ± 10 that define normality for children and adolescents of 8-18 years in Europe. Higher scores indicate a higher HRQoL.
Measured: 3 times (week 0, week 10, week 20).
Changes in perceived physical fitness - The International Fitness Scale (IFIS).
The International FItness Scale (IFIS) is a questionnaire that evaluates the physical fitness, of self-administered application, quickly and easily (Ortega et al., 2011). It consists of 5 items (general physical fitness, cardiorespiratory fitness, muscular strength, speed/agility and flexibility) and each with 5 possible Likert-scale responses: "very poor", "poor", "average", "good" or " very good".
Measured: 3 times (week 0, week 10, week 20).
Changes in sleep quality - Pittsburgh Sleep Quality Index for adolescents and young adults in Spanish version (AYA-PSQI-S
Pittsburgh Sleep Quality Index for adolescents and young adults in Spanish version (AYA-PSQI-S) (de la Vega et al., 2015) is a questionnaire slightly adapted from the original (Buysse, Reynolds C. F., Monk, Berman, \& Kupfer, 1989) to evaluate the subjective perception of sleep quality in the adolescent population. It consists of 19 items that are grouped into 7 dimensions: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The score of each component ranges from 0 (no difficulty) to 3 (severe difficulty) and the sum of all gives a total score that ranges from 0-21. A high score indicates poor sleep quality and less than 5 is considered high quality.
Measured: 3 times (week 0, week 10, week 20).

Secondary outcomes (11)

Changes in blood parameters measured in mg/dL.
The following blood parameters measured in mg/dL were analyzed: glucose; total cholesterol; triglycerides; prealbumins; transferrin; urea; creatinine; calcium; phosphorus; magnesium; potassium; creatinine kinase; testosterone.
Measured: 3 times (week 0, week 10, week 20).
Changes in blood parameters measured in g/dL.
The following blood parameters measured in g/dL were analyzed: total proteins; albumins; hemoglobin; mean corpuscular hemoglobin concentration.
Measured: 3 times (week 0, week 10, week 20).
Changes in blood parameters measured in 10^3/μL.
The following blood parameters measured in 10^3/μL were analyzed: platelets; red blood cells; leukocytes; lymphocytes; neutrophils; monocytes; basophils; eosinophils.
Measured: 3 times (week 0, week 10, week 20).
Changes in blood parameters measured in %
The following blood parameters measured in % were analyzed: hematocrit; red blood cell dispersion; transferrin saturation index.
Measured: 3 times (week 0, week 10, week 20).
Changes in blood parameters measured in fL.
The following blood parameter measured in fL were analyzed: mean corpuscular volume.
Measured: 3 times (week 0, week 10, week 20).
Changes in blood parameters measured in μg/dL
The following blood parameter measured in μg/dL were analyzed: iron.
Measured: 3 times (week 0, week 10, week 20).
Changes in blood parameters measured in mmol/L.
The following blood parameter measured in mmol/L were analyzed: sodium.
Measured: 3 times (week 0, week 10, week 20).
Changes in blood parameters measured in ng/dL
The following blood parameters measured in ng/dL were analyzed: ferritin; vitamin D; thyroxine; prolactin.
Measured: 3 times (week 0, week 10, week 20).
Changes in blood parameters measured in μUI/mL.
The following blood parameter measured in μUI/mL were analyzed: thyrotropin.
Measured: 3 times (week 0, week 10, week 20).
Changes in blood parameters measured in mUI/mL.
The following blood parameters measured in mUI/mL were analyzed: follitropin; lutropin.
Measured: 3 times (week 0, week 10, week 20).
Changes in blood parameters measured in pg/mL.
The following blood parameters measured in pg/mL were analyzed: estradiol.
Measured: 3 times (week 0, week 10, week 20).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2016Oct 2017

First posted12 Sep 2018
Study startJan 2016
Primary completionSep 2016
Study completionOct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Eating DisorderStudies of the same condition, open and under way.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03667183
Sponsor's protocol ID: UniversidadPO
Acronym: PITCA
Status last verified: Sep 2018
First submitted: 5 Sep 2018
Last updated: 12 Sep 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Garner D. Eating Disorder Inventory-3: Professional manual. Lutz, FL: Psychological Assessment Resources, Inc; 2004.
Ruiz JR, Castro-Pinero J, Espana-Romero V, Artero EG, Ortega FB, Cuenca MM, Jimenez-Pavon D, Chillon P, Girela-Rejon MJ, Mora J, Gutierrez A, Suni J, Sjostrom M, Castillo MJ. Field-based fitness assessment in young people: the ALPHA health-related fitness test battery for children and adolescents. Br J Sports Med. 2011 May;45(6):518-24. doi: 10.1136/bjsm.2010.075341. Epub 2010 Oct 19.
PubMed 20961915
Thompson MA, Gray JJ. Development and validation of a new body-image assessment scale. J Pers Assess. 1995 Apr;64(2):258-69. doi: 10.1207/s15327752jpa6402_6.
PubMed 7722852
Dion J, Blackburn ME, Auclair J, Laberge L, Veillette S, Gaudreault M, Vachon P, Perron M, Touchette E. Development and aetiology of body dissatisfaction in adolescent boys and girls. Int J Adolesc Youth. 2015 Apr 3;20(2):151-166. doi: 10.1080/02673843.2014.985320. Epub 2014 Dec 3.
PubMed 25931646
Ravens-Sieberer U, Auquier P, Erhart M, Gosch A, Rajmil L, Bruil J, Power M, Duer W, Cloetta B, Czemy L, Mazur J, Czimbalmos A, Tountas Y, Hagquist C, Kilroe J; European KIDSCREEN Group. The KIDSCREEN-27 quality of life measure for children and adolescents: psychometric results from a cross-cultural survey in 13 European countries. Qual Life Res. 2007 Oct;16(8):1347-56. doi: 10.1007/s11136-007-9240-2. Epub 2007 Aug 1.
PubMed 17668292
Ortega FB, Ruiz JR, Espana-Romero V, Vicente-Rodriguez G, Martinez-Gomez D, Manios Y, Beghin L, Molnar D, Widhalm K, Moreno LA, Sjostrom M, Castillo MJ; HELENA study group. The International Fitness Scale (IFIS): usefulness of self-reported fitness in youth. Int J Epidemiol. 2011 Jun;40(3):701-11. doi: 10.1093/ije/dyr039. Epub 2011 Mar 24.
PubMed 21441238
de la Vega R, Tome-Pires C, Sole E, Racine M, Castarlenas E, Jensen MP, Miro J. The Pittsburgh Sleep Quality Index: Validity and factor structure in young people. Psychol Assess. 2015 Dec;27(4):e22-7. doi: 10.1037/pas0000128.
PubMed 26653055
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Binge-Eating Disorder
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Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
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Active, not recruiting
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All Eating Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Levels of Body Composition, Energy Expenditure, Physical Fitness and Quality of Life in Adolescents With Eating Disorders: Effect of a Pilates Program
ClinicalTrials.gov ID: NCT03667183
Acronym / sponsor ID: PITCA / UniversidadPO
Conditions: Eating Disorder, Female Adolescents
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Universidad Pablo de OlavideUniversity, hospital or other
Collaborators: Complejo Hospitalario Universitario de Huelva
Study start: Jan 2016 (actual)
Primary completion: Sep 2016 (actual)
Study completion: Oct 2017 (actual)
First posted: 12 Sep 2018 (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.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pilates Group	Experimental	Other: PilatesFemale adolescents with eating disorders who receive Pilates for 10 weeks.

Who may qualify

Ages: 10 to 17 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

1) clinical diagnosis of EDs in the aforementioned hospital;
2) aged from 10 to 17 years old;
3) written informed consent by the patients and their legal guardians

Key exclusion criteria (2 listed)

1) have other diagnoses of mental illness or
2) consumption of narcotic toxins

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
PilatesSpecific postures in movement according to Pilates guidelines.	Other	Pilates Group

Primary outcome

Changes in psychopathology - Eating Disorder Inventory-3 (EDI-3).
Time frame: 3 times (week 0, week 10, week 20).
EDI-3 (Garner, 2004) is a self-report questionnaire that assesses the presence of eating disorders. The EDI-3 is composed of 91 items, organized into 12 main scales: 3 specific scales of eating behavior disorders (Drive for Thinness, DT; Bulimia, B; Body Dissatisfaction, BD) and 9 general psychological scales that are highly relevant, but not specific to eating disorders (Low Self-Esteem, LSE; Personal Alienation, PA; Interpersonal Insecurity, II; Interpersonal Alienation, IA; Interoceptive Deficits, ID; Emotional Dysregulation, ED; Perfectionism, P; Asceticism, A; Maturity Fears, MF). It also provides 6 composite scores: a specific one of the ED and 5 indices of integrative psychological constructs. The format of six-point Likert-scale responses: always, usually, often, sometimes, rarely or never. The score is between 0 and 4 points. The higher the score, the greater the disorder.
Changes in energy expenditure - SenseWear Mini (SWM).
Time frame: 3 times (week 0, week 10, week 20).
SenseWear Mini is a multi-sensor activity monitor that combines tri-axial accelerometry with physiological measurements (skin temperature, heat flux and galvanic skin response) for the estimation of several activity parameters. The information of the different sensors, together with the personal characteristics of the participant (sex, age, height, body weight and the use of hands) is processed through proprietary algorithms of the SenseWear software to estimate the energy expenditure, intensity of physical activity and the number of steps on a minute-by-minute basis.
Changes in body composition - InBody 770 (Body Composition Analyzer).
Time frame: 3 times (week 0, week 10, week 20).
InBody 770 (Inbody Co., LTD, Seoul, Korea) to measure body composition through bioelectrical impedance analysis (BIA). Parameters evaluated: Weight (kg); Total Body Water (L); Protein (kg); Minerals (kg); Body Fat Mass (kg); Soft Lean Mass (kg); Fat Free Mass (kg); Skeletal Muscle Mass (kg); Body Mass Index (kg/m2); Percent Body Fat (%); Bone Mineral Contect (kg).
Changes in physical fitness - ALPHA-Fitness Battery.
Time frame: 3 times (week 0, week 10, week 20).
ALPHA-Fitness Battery (Assessing Levels of Physical Activity and Fitness) was developed to provide a set of valid, reliable, safe and feasible field tests, in order to assess the physical fitness related to health in children and adolescents, and thus be used in a consensual manner in the Public Health system of the different member states of the European Union. There are three versions of the ALPHA-Fitness battery slightly different depending on the time available for the administration of the tests. We used the extended ALPHA-Fitness Battery. This version of the battery includes handgrip strength, standing broad jump, 4x10 m shuttle run test and 20 m shuttle run test (Ruiz et al., 2011).
Changes in body perception - The Contour Drawing Rating Scale (CDRS).
Time frame: 3 times (week 0, week 10, week 20).
The Contour Drawing Rating Scale (CDRS) (Thompson \& Gray, 1995) is a scale that evaluates the alterations of the body image. This instrument is a graphic scale, self-administered application, composed of nine female figures views from the front. The person is asked to indicate which figure represents their current body image (perceived body image) and what figure they would like to have (desired body image). The discrepancy between these two classifications represents a measure of body dissatisfaction. The degree of discrepancy varied between -8 and -1 for those who desire a thinner form and between 1 and 8 for those who desire a larger form. A score of 0 was interpreted as satisfaction with body image (Dion et al., 2015). On the other hand, the body image perception index is determined by the following formula: (Estimated size / Actual size) x 100, which would indicate over-estimation when the scores are greater than 100 and underestimation when they are less than 100.
Changes in the quality of life - KIDSCREEN-27.
Time frame: 3 times (week 0, week 10, week 20).
KIDSCREEN-27 is a self-administered questionnaire that assesses the health and subjective well-being of children and adolescents (between the ages of 8 and 18) (Ravens-Sieberer et al., 2007). This questionnaire is composed of five dimensions on the Rasch scale: physical well-being, psychological well-being, autonomy and parent relation, peers and social support and school environment. The responses were evaluated and analyzed according to standard algorithms. The recommended syntax steps were performed, including the transformation of Rasch person parameter estimates into Z values, obtaining scale scores as T values with mean scores (± SD) of 50 ± 10 that define normality for children and adolescents of 8-18 years in Europe. Higher scores indicate a higher HRQoL.
Changes in perceived physical fitness - The International Fitness Scale (IFIS).
Time frame: 3 times (week 0, week 10, week 20).
The International FItness Scale (IFIS) is a questionnaire that evaluates the physical fitness, of self-administered application, quickly and easily (Ortega et al., 2011). It consists of 5 items (general physical fitness, cardiorespiratory fitness, muscular strength, speed/agility and flexibility) and each with 5 possible Likert-scale responses: "very poor", "poor", "average", "good" or " very good".
Changes in sleep quality - Pittsburgh Sleep Quality Index for adolescents and young adults in Spanish version (AYA-PSQI-S
Time frame: 3 times (week 0, week 10, week 20).
Pittsburgh Sleep Quality Index for adolescents and young adults in Spanish version (AYA-PSQI-S) (de la Vega et al., 2015) is a questionnaire slightly adapted from the original (Buysse, Reynolds C. F., Monk, Berman, \& Kupfer, 1989) to evaluate the subjective perception of sleep quality in the adolescent population. It consists of 19 items that are grouped into 7 dimensions: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The score of each component ranges from 0 (no difficulty) to 3 (severe difficulty) and the sum of all gives a total score that ranges from 0-21. A high score indicates poor sleep quality and less than 5 is considered high quality.

11 secondary outcomes

Changes in blood parameters measured in mg/dL.
Time frame: 3 times (week 0, week 10, week 20).
Changes in blood parameters measured in g/dL.
Time frame: 3 times (week 0, week 10, week 20).
Changes in blood parameters measured in 10^3/μL.
Time frame: 3 times (week 0, week 10, week 20).
Changes in blood parameters measured in %
Time frame: 3 times (week 0, week 10, week 20).
Changes in blood parameters measured in fL.
Time frame: 3 times (week 0, week 10, week 20).
Changes in blood parameters measured in μg/dL
Time frame: 3 times (week 0, week 10, week 20).
Changes in blood parameters measured in mmol/L.
Time frame: 3 times (week 0, week 10, week 20).
Changes in blood parameters measured in ng/dL
Time frame: 3 times (week 0, week 10, week 20).
Changes in blood parameters measured in μUI/mL.
Time frame: 3 times (week 0, week 10, week 20).
Changes in blood parameters measured in mUI/mL.
Time frame: 3 times (week 0, week 10, week 20).
Changes in blood parameters measured in pg/mL.
Time frame: 3 times (week 0, week 10, week 20).

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 12 Sep 2018.
BackgroundGarner D. Eating Disorder Inventory-3: Professional manual. Lutz, FL: Psychological Assessment Resources, Inc; 2004.
Background: PubMed 20961915Ruiz JR, Castro-Pinero J, Espana-Romero V, Artero EG, Ortega FB, Cuenca MM, Jimenez-Pavon D, Chillon P, Girela-Rejon MJ, Mora J, Gutierrez A, Suni J, Sjostrom M, Castillo MJ. Field-based fitness assessment in young people: the ALPHA health-related fitness test battery for children and adolescents. Br J Sports Med. 2011 May;45(6):518-24. doi: 10.1136/bjsm.2010.075341. Epub 2010 Oct 19.
Background: PubMed 7722852Thompson MA, Gray JJ. Development and validation of a new body-image assessment scale. J Pers Assess. 1995 Apr;64(2):258-69. doi: 10.1207/s15327752jpa6402_6.
Background: PubMed 25931646Dion J, Blackburn ME, Auclair J, Laberge L, Veillette S, Gaudreault M, Vachon P, Perron M, Touchette E. Development and aetiology of body dissatisfaction in adolescent boys and girls. Int J Adolesc Youth. 2015 Apr 3;20(2):151-166. doi: 10.1080/02673843.2014.985320. Epub 2014 Dec 3.
Background: PubMed 17668292Ravens-Sieberer U, Auquier P, Erhart M, Gosch A, Rajmil L, Bruil J, Power M, Duer W, Cloetta B, Czemy L, Mazur J, Czimbalmos A, Tountas Y, Hagquist C, Kilroe J; European KIDSCREEN Group. The KIDSCREEN-27 quality of life measure for children and adolescents: psychometric results from a cross-cultural survey in 13 European countries. Qual Life Res. 2007 Oct;16(8):1347-56. doi: 10.1007/s11136-007-9240-2. Epub 2007 Aug 1.
Background: PubMed 21441238Ortega FB, Ruiz JR, Espana-Romero V, Vicente-Rodriguez G, Martinez-Gomez D, Manios Y, Beghin L, Molnar D, Widhalm K, Moreno LA, Sjostrom M, Castillo MJ; HELENA study group. The International Fitness Scale (IFIS): usefulness of self-reported fitness in youth. Int J Epidemiol. 2011 Jun;40(3):701-11. doi: 10.1093/ije/dyr039. Epub 2011 Mar 24.
Background: PubMed 26653055de la Vega R, Tome-Pires C, Sole E, Racine M, Castarlenas E, Jensen MP, Miro J. The Pittsburgh Sleep Quality Index: Validity and factor structure in young people. Psychol Assess. 2015 Dec;27(4):e22-7. doi: 10.1037/pas0000128.
Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
Individual participant dataSharing planned: Undecided

Related trials for Eating Disorder

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Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Pilates in people with Eating Disorder and Female Adolescents, run by Universidad Pablo de Olavide.

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 3 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 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Changes in psychopathology - Eating Disorder Inventory-3 (EDI-3). (time frame: 3 times (week 0, week 10, week 20).). The study lists 8 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 NCT03667183, which also lists 8 linked publications.

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 12 Sep 2018.