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Overweight and ObesityNCT03927534

Efficacy of a Mindful-eating Program to Reduce Emotional Eating

A study testing Mindful Eating in people with Overweight and Obesity, run by Hospital Miguel Servet at 1 site in Spain.

Completed

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

Official record
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Trial summary

Mindfulness-Based Interventions have been applied in different fields to improve physical and psychological health. However, little is known about its applicability and effectiveness in Spanish adults with overweight and obesity. Read more about this study

Who is it for?
Ages 45 to 75 years
Conditions the study is for
Overweight and Obesity
What is being tested?
Mindful Eating
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteSpain
Study dates
1 May 2019to 30 Aug 2020
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 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 45-75 years
  • Have overweight or obesity condition based in BMI (Body Mass Index). Individuals with BMI of 25 or more.
  • Have two of these three risk: sedentary lifestyle, poor diet and binge episodes.
  • Ability to understand oral and written Spanish.
  • Willingness to participate in the study and signing informed consent.

Who cannot join

  • Any diagnosis of a disease that may affect the central nervous system (brain condition, traumatic brain injury, dementia, etc).
  • Other psychiatric diagnoses or acute psychiatric illness (substance dependence or abuse, history of schizophrenia or other psychotic disorders, etc.), except for anxiety disorder or personality disorders.
  • Presence of delusional ideas or hallucinations whether consistent or not with mood.
  • Suicide risk.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Department of Psychiatry. Miguel Servet University Hospital

    Zaragoza, 50009

Other trials in Spain

About this study

Official title: Efficacy of a Mindful Eating Program to Reduce Emotional Eating in Patients Suffering From Overweight or Obesity in Primary Care Settings: a Cluster Randomized Controlled Clinical Trial Protocol

Mindfulness-Based Interventions have been applied in different fields to improve physical and psychological health. However, little is known about its applicability and effectiveness in Spanish adults with overweight and obesity. The aim of the present study protocol is to evaluate the feasibility and efficacy of an adapted MBI programme to reduce emotional eating in adults with overweight and obesity in primary care (PC) settings.

Read the detailed description

This study is a multi-centre, two-armed randomized controlled trial (RCT), with pre-treatment, post-treatment and 1-year follow-up measures, and a 1:1 allocation rate between groups. Patients from four mental health units in Zaragoza (Spain) will be randomly assigned to two different parallel conditions, with one psychological intervention group ('ME + TAU') and usual treatment ('TAU alone') managed by their general practitioner (GP), to test the superiority of 'ME + TAU' provision compared with 'TAU alone' provision. For ethical reasons, those patients allocated to 'TAU alone' will be offered the ME programme after finishing the trial at 1-year follow-up.

Being tested
Mindful Eating
Keywords
Obesity, Overweight, Mindful Eating, Primary Care, Randomized controlled trial (RCT)
Medical subject headings
Overweight, Obesity

What participants receive

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

  • Mindful EatingBehavioural

    The ME group will be composed by 7 weekly group sessions with a minimum duration of two hours, mixing theoretical contents with practices. Sessions will always be the same day of the week, except for bank holidays or eventualities, and will be conducted by a psychologist specially trained and certified in ME with experience in leading mindfulness groups. Group sizes will range between 10 and 12 participants. At the end of each session, participants will receive theoretical contents and homework activities to be practiced along the week.

Study groups in NCT03927534
Study groupRoleWhat they receive
ExperimentalExperimentalMindful Eating program is apply face to face 7 sessions of 120 minutes/session. ME is apply in groups of 10-12 people in traditional format. Written material and sound recordings will be offered as support elements. The estimated duration of the face to face program is two months.
Receives: Behavioral: Mindful Eating
ControlNo interventionTreatment As Usual (TAU) in Primary Care (PC) is any kind of treatment administered by the GP to the patient with overweight and obesity. According to nutritional status, overweight or obesity, as well as the presence of co-morbidity, different actions can comprise the treatment offered at a PC level. For individuals presenting with overweight (BMI 25-29.9 kg/m2) but with no co-morbidities, PC teams organise care plans to enable them to achieve a normal BMI range (BMI 18.5-24.9 kg/m2). In case of suicide risk, severe social dysfunction or worsening of symptoms, it is recommended that patients are referred to mental health facilities.

What is being measured

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

  1. The Dutch Eating Behavior Questionnaire

    It was designed to measure eating styles that may attenuate or contribute to the development of overweight. It comprises three scales that measure emotional, external and restrained eating. The Spanish version of the DEBQ has 33 items, 13 of them referred to the emotional eating scale (e.g., "Desire to eat when irritated"), and 10 items referring to the external (e.g., "Eating when you feel lonely") and restrictive (e.g., "Difficult to resist delicious food") scales, respectively. The items can be rated on a five-point likert scale with 1 indicating "never" and 5 indicating "very often".

    Measured: Baseline in experimental and control groups.

  2. The Dutch Eating Behavior Questionnaire

    It was designed to measure eating styles that may attenuate or contribute to the development of overweight. It comprises three scales that measure emotional, external and restrained eating. The Spanish version of the DEBQ has 33 items, 13 of them referred to the emotional eating scale (e.g., "Desire to eat when irritated"), and 10 items referring to the external (e.g., "Eating when you feel lonely") and restrictive (e.g., "Difficult to resist delicious food") scales, respectively. The items can be rated on a five-point likert scale with 1 indicating "never" and 5 indicating "very often".

    Measured: Post-treatment 8 weeks from baseline in experimental and control groups

  3. The Dutch Eating Behavior Questionnaire

    It was designed to measure eating styles that may attenuate or contribute to the development of overweight. It comprises three scales that measure emotional, external and restrained eating. The Spanish version of the DEBQ has 33 items, 13 of them referred to the emotional eating scale (e.g., "Desire to eat when irritated"), and 10 items referring to the external (e.g., "Eating when you feel lonely") and restrictive (e.g., "Difficult to resist delicious food") scales, respectively. The items can be rated on a five-point likert scale with 1 indicating "never" and 5 indicating "very often".

    Measured: twelve-months follow-up in experimental and control groups

Secondary outcomes (40)

  1. Sociodemographic data Gender, age, marital status, education, occupation, economical level

    Measured: Baseline in experimental and control groups

  2. Five Facet Mindfulness Questionnaire

    The FFMQ-short form is a 24-item questionnaire that measures five aspects of mindfulness and there is a Spanish version based on it with appropriate psychometrics. The five facets the FFMQ measures are: observing (α = 81), describing (α = .87), acting with awareness (5 items, α = .83), non-judging to (5 items, α = .83) and non-reacting of (5 items, α = .75) inner experience. The participants indicate on a 5-point Likert scale the degree in which each item is generally true for them, ranging from 1 ("never or very rarely true") to 5 ("very often or always true").

    Measured: Baseline in experimental and control groups

  3. Five Facet Mindfulness Questionnaire

    The FFMQ-short form is a 24-item questionnaire that measures five aspects of mindfulness and there is a Spanish version based on it with appropriate psychometrics. The five facets the FFMQ measures are: observing (α = 81), describing (α = .87), acting with awareness (5 items, α = .83), non-judging to (5 items, α = .83) and non-reacting of (5 items, α = .75) inner experience. The participants indicate on a 5-point Likert scale the degree in which each item is generally true for them, ranging from 1 ("never or very rarely true") to 5 ("very often or always true").

    Measured: Post-treatment 8 weeks from baseline in experimental and control groups

  4. Five Facet Mindfulness Questionnaire

    The FFMQ-short form is a 24-item questionnaire that measures five aspects of mindfulness and there is a Spanish version based on it with appropriate psychometrics. The five facets the FFMQ measures are: observing (α = 81), describing (α = .87), acting with awareness (5 items, α = .83), non-judging to (5 items, α = .83) and non-reacting of (5 items, α = .75) inner experience. The participants indicate on a 5-point Likert scale the degree in which each item is generally true for them, ranging from 1 ("never or very rarely true") to 5 ("very often or always true").

    Measured: twelve-months follow-up in experimental and control groups

  5. Self-Compassion Scale

    It is the most used self-report instrument to measure self-compassion and it is divided into six subscales: Self-Kindness; Self-Judgment; Common Humanity; Isolation; Mindfulness; and Over-Identification. The items can be rated on a five-point Likert-type scale with 1 indicating "almost never" and 5 indicating "almost always". After reversing the negatively formulated items, a total score can be calculated, which may range from 24 to 120, with higher scores indicating greater self-compassion

    Measured: Baseline in experimental and control groups

  6. Self-Compassion Scale

    It is the most used self-report instrument to measure self-compassion and it is divided into six subscales: Self-Kindness; Self-Judgment; Common Humanity; Isolation; Mindfulness; and Over-Identification. The items can be rated on a five-point Likert-type scale with 1 indicating "almost never" and 5 indicating "almost always". After reversing the negatively formulated items, a total score can be calculated, which may range from 24 to 120, with higher scores indicating greater self-compassion

    Measured: Post-treatment 8 weeks from baseline in experimental and control groups

  7. Self-Compassion Scale

    It is the most used self-report instrument to measure self-compassion and it is divided into six subscales: Self-Kindness; Self-Judgment; Common Humanity; Isolation; Mindfulness; and Over-Identification. The items can be rated on a five-point Likert-type scale with 1 indicating "almost never" and 5 indicating "almost always". After reversing the negatively formulated items, a total score can be calculated, which may range from 24 to 120, with higher scores indicating greater self-compassion

    Measured: twelve-months follow-up in experimental and control groups

  8. Mindful Eating Scale

    The MES scale has 28 items, including six factors: acceptance (α = .89), awareness (α = .82), non-reactivity (α = .77), act with awareness (α = .81), routine (α = .75) and unstructured eating (α = .60). Items can be rated on a 4-point Likert-type scale, with 1 indicating "never" and 4 indicating "very often".

    Measured: Baseline in experimental and control groups

  9. Mindful Eating Scale

    The MES scale has 28 items, including six factors: acceptance (α = .89), awareness (α = .82), non-reactivity (α = .77), act with awareness (α = .81), routine (α = .75) and unstructured eating (α = .60). Items can be rated on a 4-point Likert-type scale, with 1 indicating "never" and 4 indicating "very often".

    Measured: Post-treatment 8 weeks from baseline in experimental and control groups

  10. Mindful Eating Scale

    The MES scale has 28 items, including six factors: acceptance (α = .89), awareness (α = .82), non-reactivity (α = .77), act with awareness (α = .81), routine (α = .75) and unstructured eating (α = .60). Items can be rated on a 4-point Likert-type scale, with 1 indicating "never" and 4 indicating "very often".

    Measured: twelve-months follow-up in experimental and control groups

  11. Bulimic Investigatory Test

    The BITE is very used to measure the presence and severity of bulimic symptoms in nonclinical samples. Normative values for BITE total and sub-scale scores in clinical and non-clinical samples are reported. The scale includes in the Symptoms subscale (30 yes-no items; range =0-30) and Severity subscale (6 dimensional items addressing specific bulimic behaviors; range=0-39). In addition to these standars scores, another measure was derived from the BITE-the reported frequency of bingeing

    Measured: Baseline in experimental and control groups

  12. Bulimic Investigatory Test

    The BITE is very used to measure the presence and severity of bulimic symptoms in nonclinical samples. Normative values for BITE total and sub-scale scores in clinical and non-clinical samples are reported. The scale includes in the Symptoms subscale (30 yes-no items; range =0-30) and Severity subscale (6 dimensional items addressing specific bulimic behaviors; range=0-39). In addition to these standars scores, another measure was derived from the BITE-the reported frequency of bingeing

    Measured: Post-treatment 8 weeks from baseline in experimental and control groups

  13. Bulimic Investigatory Test

    The BITE is very used to measure the presence and severity of bulimic symptoms in nonclinical samples. Normative values for BITE total and sub-scale scores in clinical and non-clinical samples are reported. The scale includes in the Symptoms subscale (30 yes-no items; range =0-30) and Severity subscale (6 dimensional items addressing specific bulimic behaviors; range=0-39). In addition to these standars scores, another measure was derived from the BITE-the reported frequency of bingeing

    Measured: twelve-months follow-up in experimental and control groups

  14. Eating Attitude test (EAT-26)

    The EAT-26 had three subscales Dieting, Bulimia and Food Preocupation, and Oral Control. It is and abbreviated version of the original EAT-40, having an excellent correlation. In the EAT-26 each item is answered on a 6-point Lickert scale and if the scoring is 20 or higher the patient should look for professional advice. The Eat-26 had an elevated reliability

    Measured: Baseline in experimental and control groups

  15. Eating Attitude test (EAT-26)

    The EAT-26 had three subscales Dieting, Bulimia and Food Preocupation, and Oral Control. It is and abbreviated version of the original EAT-40, having an excellent correlation. In the EAT-26 each item is answered on a 6-point Lickert scale and if the scoring is 20 or higher the patient should look for professional advice. The Eat-26 had an elevated reliability

    Measured: Post-treatment 8 weeks from baseline in experimental and control groups

  16. Eating Attitude test (EAT-26)

    The EAT-26 had three subscales Dieting, Bulimia and Food Preocupation, and Oral Control. It is and abbreviated version of the original EAT-40, having an excellent correlation. In the EAT-26 each item is answered on a 6-point Lickert scale and if the scoring is 20 or higher the patient should look for professional advice. The Eat-26 had an elevated reliability

    Measured: twelve-months follow-up in experimental and control groups

  17. Weight

    Weight measurement will be quantified in kilograms using a digital scale

    Measured: Baseline in experimental and control groups

  18. Weight

    Weight measurement will be quantified in kilograms using a digital scale

    Measured: twelve-months follow-up in experimental and control groups

  19. Abdominal perimeter

    Abdominal perimeter measurement will be quantified in centimetres using a measuring tape

    Measured: Baseline in experimental and control groupsw-up in experimental and control groups

  20. Abdominal perimeter

    Abdominal perimeter measurement will be quantified in centimetres using a measuring tape

    Measured: twelve-months follow-up in experimental and control groups

  21. Height

    Height measurement will be quantified in centimetres using a measuring tape

    Measured: Baseline in experimental and control groups

  22. Height

    Height measurement will be quantified in centimetres using a measuring tape

    Measured: twelve-months follow-up in experimental and control groups

  23. Cholesterol total

    Cholesterol total measurement will be quantified mg/dL using a blood test

    Measured: Baseline in experimental and control groups

  24. Cholesterol total

    Cholesterol total measurement will be quantified mg/dL using a blood test

    Measured: twelve-months follow-up in experimental and control groups

  25. LDL

    LDL measurement will be quantified mg/dL using a blood test

    Measured: Baseline in experimental and control groups

  26. LDL

    LDL measurement will be quantified mg/dL using a blood test

    Measured: twelve-months follow-up in experimental and control groups

  27. HDL

    HDL measurement will be quantified mg/dL using a blood test

    Measured: Baseline in experimental and control groups

  28. HDL

    HDL measurement will be quantified mg/dL using a blood test

    Measured: twelve-months follow-up in experimental and control groups

  29. Glucose

    Glucose measurement will be quantified mg/dL using a blood test

    Measured: Baseline in experimental and control groups

  30. Glucose

    Glucose measurement will be quantified mg/dL using a blood test

    Measured: twelve-months follow-up in experimental and control groups

  31. Alanine aminotransferase

    Alanine aminotransferase measurement will be quantified U/L using a blood test

    Measured: Baseline in experimental and control groups

  32. Alanine aminotransferase

    Alanine aminotransferase measurement will be quantified U/L using a blood test

    Measured: twelve-months follow-up in experimental and control groups

  33. Glycated haemoglobin

    Glycated haemoglobin measurement will be quantified in percentage (%) using a blood test

    Measured: Baseline in experimental and control groups

  34. Glycated haemoglobin

    Glycated haemoglobin measurement will be quantified in percentage (%) using a blood test

    Measured: twelve-months follow-up in experimental and control groups

  35. General Anxiety Disorder

    It is one of the most frequently used diagnostic self-report scales for screening, diagnosis and anxiety disorder severity assessment, defined as an excessive anxiety and worry (apprehensive expectation) related to a number of events or activities, associated to experiencing difficulties to control that worry. Items are rated on a 4-point Likert-type scale (between 0 = "not at all" and 3 = "nearly every day"). The GAD-7 inquires about events happening over the last two weeks, in order to know how often the patient has been bothered by them

    Measured: Baseline in experimental and control groups

  36. General Anxiety Disorder

    It is one of the most frequently used diagnostic self-report scales for screening, diagnosis and anxiety disorder severity assessment, defined as an excessive anxiety and worry (apprehensive expectation) related to a number of events or activities, associated to experiencing difficulties to control that worry. Items are rated on a 4-point Likert-type scale (between 0 = "not at all" and 3 = "nearly every day"). The GAD-7 inquires about events happening over the last two weeks, in order to know how often the patient has been bothered by them

    Measured: twelve-months follow-up in experimental and control groups

  37. Patient Health Questionnaire

    This scale is one of the most widely used questionnaires that assess the intensity of depression in pharmacological and psychological studies, it is useful to monitor changes experienced by patients over time. Through items like "Little interest or pleasure in doing things" and using a Liker-type scale from 0 ("not at all") to 3 ("nearly every day"), the PHQ-9 reflects the experience of participants during the last two weeks.

    Measured: Baseline in experimental and control groups

  38. Patient Health Questionnaire

    This scale is one of the most widely used questionnaires that assess the intensity of depression in pharmacological and psychological studies, it is useful to monitor changes experienced by patients over time. Through items like "Little interest or pleasure in doing things" and using a Liker-type scale from 0 ("not at all") to 3 ("nearly every day"), the PHQ-9 reflects the experience of participants during the last two weeks.

    Measured: twelve-months follow-up in experimental and control groups

  39. The diastolic blood pressure (DBP) and the systolic blood pressure (SBP)

    In order to evaluate the vital signs we will use a vascular screening system, in the version VaSera VS-1500.

    Measured: Baseline in experimental and control groups

  40. The diastolic blood pressure (DBP) and the systolic blood pressure (SBP)

    In order to evaluate the vital signs we will use a vascular screening system, in the version VaSera VS-1500.

    Measured: twelve-months follow-up in experimental and control groups

Timeline

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

  1. First posted25 Apr 2019
  2. Study start1 May 2019
  3. Primary completion31 Aug 2019
  4. Study completion30 Aug 2020

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03927534
Sponsor's protocol ID
05/2019
Status last verified
Feb 2021
First submitted
19 Apr 2019
Last updated
23 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Once available, the results of the trial will be presented at national and international conferences and in peer-reviewed journal publications. Due to the clinical nature of the study and considering ethical concerns, the data (anonymised and completely de-identified) generated by this trial will be made available upon request to researchers a) who provide a methodologically sound proposal and b) whose proposed use of the data has been approved by an independent ethical review committee. Data will become available following each publication with no end date for replicating the results of the trial or for any analytical purpose that is related to achieve aims in the original proposal. The database will be encrypted and password protected (passwords will be provided by the corresponding author to researchers that meet the referred criteria).

Publications

  • Rossner S. Obesity: the disease of the twenty-first century. Int J Obes Relat Metab Disord. 2002 Dec;26 Suppl 4:S2-4. doi: 10.1038/sj.ijo.0802209.

    PubMed 12457290

  • Mann T, Tomiyama AJ, Westling E, Lew AM, Samuels B, Chatman J. Medicare's search for effective obesity treatments: diets are not the answer. Am Psychol. 2007 Apr;62(3):220-33. doi: 10.1037/0003-066X.62.3.220.

    PubMed 17469900

  • Holzel BK, Lazar SW, Gard T, Schuman-Olivier Z, Vago DR, Ott U. How Does Mindfulness Meditation Work? Proposing Mechanisms of Action From a Conceptual and Neural Perspective. Perspect Psychol Sci. 2011 Nov;6(6):537-59. doi: 10.1177/1745691611419671.

    PubMed 26168376

  • Kristeller JL, Hallett CB. An Exploratory Study of a Meditation-based Intervention for Binge Eating Disorder. J Health Psychol. 1999 May;4(3):357-63. doi: 10.1177/135910539900400305.

    PubMed 22021603

  • Medina WL, Wilson D, de Salvo V, Vannucchi B, de Souza EL, Lucena L, Sarto HM, Modrego-Alarcon M, Garcia-Campayo J, Demarzo M. Effects of Mindfulness on Diabetes Mellitus: Rationale and Overview. Curr Diabetes Rev. 2017;13(2):141-147. doi: 10.2174/1573399812666160607074817.

    PubMed 27280721

  • Rosenzweig S, Reibel DK, Greeson JM, Edman JS, Jasser SA, McMearty KD, Goldstein BJ. Mindfulness-based stress reduction is associated with improved glycemic control in type 2 diabetes mellitus: a pilot study. Altern Ther Health Med. 2007 Sep-Oct;13(5):36-8.

    PubMed 17900040

  • Miller CK, Kristeller JL, Headings A, Nagaraja H, Miser WF. Comparative effectiveness of a mindful eating intervention to a diabetes self-management intervention among adults with type 2 diabetes: a pilot study. J Acad Nutr Diet. 2012 Nov;112(11):1835-42. doi: 10.1016/j.jand.2012.07.036.

    PubMed 23102183

  • Fanning J, Osborn CY, Lagotte AE, Mayberry LS. Relationships between dispositional mindfulness, health behaviors, and hemoglobin A1c among adults with type 2 diabetes. J Behav Med. 2018 Dec;41(6):798-805. doi: 10.1007/s10865-018-9938-3. Epub 2018 May 25.

    PubMed 29802533

  • Mantzios M, Wilson JC. Mindfulness, Eating Behaviours, and Obesity: A Review and Reflection on Current Findings. Curr Obes Rep. 2015 Mar;4(1):141-6. doi: 10.1007/s13679-014-0131-x.

    PubMed 26627097

  • Godsey J. The role of mindfulness based interventions in the treatment of obesity and eating disorders: an integrative review. Complement Ther Med. 2013 Aug;21(4):430-9. doi: 10.1016/j.ctim.2013.06.003. Epub 2013 Jul 9.

    PubMed 23876574

  • Mason AE, Epel ES, Kristeller J, Moran PJ, Dallman M, Lustig RH, Acree M, Bacchetti P, Laraia BA, Hecht FM, Daubenmier J. Effects of a mindfulness-based intervention on mindful eating, sweets consumption, and fasting glucose levels in obese adults: data from the SHINE randomized controlled trial. J Behav Med. 2016 Apr;39(2):201-13. doi: 10.1007/s10865-015-9692-8. Epub 2015 Nov 12.

    PubMed 26563148

  • Morillo Sarto H, Barcelo-Soler A, Herrera-Mercadal P, Pantilie B, Navarro-Gil M, Garcia-Campayo J, Montero-Marin J. Efficacy of a mindful-eating programme to reduce emotional eating in patients suffering from overweight or obesity in primary care settings: a cluster-randomised trial protocol. BMJ Open. 2019 Nov 21;9(11):e031327. doi: 10.1136/bmjopen-2019-031327.

    PubMed 31753880

Questions about this trial

What is this clinical trial studying?

A study testing Mindful Eating in people with Overweight and Obesity, run by Hospital Miguel Servet at 1 site in Spain.

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 5 inclusion and 4 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 23 Feb 2021. 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 Spain. 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?

The Dutch Eating Behavior Questionnaire (time frame: Baseline in experimental and control groups.). The study lists 3 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 NCT03927534, which also lists 12 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 23 Feb 2021.

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