Overweight and ObesityMind&LifeNCT03718728
Effect of a Group Intervention Program Based on Acceptance and Mindfulness on the Physical and Emotional Well-being of Overweight and Obese Individuals
A study testing Mind&Life and Standard in people with Overweight and Obesity, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.
Trial summary
The objective of the present study is to evaluate the effect of a 20-week group intervention program based on acceptance and mindfulness in emotional eating, weight loss, physiological parameters and the level of physical exercise, as well as in the quality-of-life and weight self-stigma of overweight and obese people… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Mind&Life and Standard
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteSpain
- Study dates
- 3 Nov 2018to 1 Oct 2022
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with overweight or obesity (estimated by BMI ≥ 25 and classified by the International Obesity Task Force, IOTF);
- Have asked for enrollment in nutritional treatment for weight loss in primary care units from Donostia-San Sebastian;
- Willingness to participate in the study.
Who cannot join
- Diagnosed with eating disorders; such as, Binge Eating Disorder, Anorexia or Bulimia;
- Diagnosed with any psychiatric disorder or intellectual disability that doesn't allow to carry out the intervention;
- Not to know sufficiently the language the intervention is carried out.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Personality Assesment and Psychological Treatments of the Faculty of Psychology of the Basque Country University (UPV/EHU)
Donostia / San Sebastian, Gipuzkoa, 20018
About this study
Official title: The Effect of a Group Intervention Program Based on Acceptance and Mindfulness on the Physical and Emotional Well-being of Overweight and Obese Individuals; Mind&Life Project
The objective of the present study is to evaluate the effect of a 20-week group intervention program based on acceptance and mindfulness in emotional eating, weight loss, physiological parameters and the level of physical exercise, as well as in the quality-of-life and weight self-stigma of overweight and obese people on the short- and medium-term.
Design, participants, and method: A randomized clinical trial comprising a total of 110 overweight or obese (BMI ≥ 25) participants that are receiving medical treatment at Primary Care Centers, 20-65 years, will be included and randomly assigned to standard program (N=55) or standard + intervention program (N=55). The standard program group will receive the treatment as usual (TAU) that comprises 5 sessions (on a monthly basis) that will include a personalized diet and physical exercise recommendations, while the standard + intervention program group will receive the same TAU plus the acceptance and mindfulness-based group intervention program.
Read more
At baseline prior to randomization, after the intervention, and seven months after the program has finished anthropometric and body composition data, biochemical data in blood, waist circumference, blood pressure, eating habits, level of physical exercise, general health, emotional eating, quality-of-life, weight self-stigma, experiential avoidance, self-compassion level and mindfulness abilities will be evaluated.
It is hypothesized that the integrated treatment of obesity implementing a group intervention program based on acceptance and mindfulness could help to reduce the emotional eating, enhance weight loss, improve physiological parameters, increase the level of physical exercise, improve the quality of life and reduce the weight self-stigma of overweight and obese individuals.
Read the detailed description
The standard program group will receive the TAU that comprises 5 monthly sessions of 30 minutes that will include a personalized diet and physical exercise recommendations.
The standard + intervention program group will receive the same TAU plus the acceptance and mindfulness-based group intervention program. The first ten sessions will be held weekly and the last five, biweekly. The duration of sessions will be 2 hours and will include a mindfulness practice, the session content (i.e. control as the problem, willingness, etc.), followed by a mindful eating practice to train the ability to pay attention to food and eating physical sensations. Finally, the session content will be briefly revised and practices for the week will be established.
The following measurements will be evaluated at baseline prior to randomization, after the intervention, and seven months after the program has finished: anthropometric and body composition data, that is, weight and fat and muscle mass percentage (Bio-electrical Impedance Analysis, TANITA) and height (SECA 227); biochemical data in blood; waist circumference (Holtain inelastic tape); blood pressure; eating habits (24h recall and PREDIMED); level of physical exercise (IPAQ); general health (GHQ-28); emotional eating (DEBQ); quality-of-life (IWQOL-Lite); weight self-stigma (WSSQ); experiential avoidance (AAQ-II); self-compassion level (SCS) and mindfulness abilities (FFMQ).
- Conditions
- Overweight and Obesity
- Being tested
- Mind&Life, Standard
- Keywords
- Overweight, Obesity, Adults, Mindfulness, Acceptance, Emotional eating
- Medical subject headings
- Overweight, Obesity, Emotional Eating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind&LifeBehavioural
Acceptance and mindfulness-based group intervention program.
StandardBehavioural
Personalized diet and physical exercise recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Standard group | Active comparator | A personalized diet and physical exercise recommendations. Receives: Behavioral: Standard |
| Mind&Life (standard + intervention) group | Experimental | A personalized diet and physical exercise recommendations plus the acceptance and mindfulness-based group intervention program. Receives: Behavioral: Mind&Life; Behavioral: Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Body Mass Index (BMI) measured by Bio-electrical Impedance Analysis (TANITA)
Changes in Body Mass Index (BMI - kg/m2) will be measured by Bio-electrical Impedance Analysis (TANITA).
Measured: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in eating habits estimated by 24h recall and PREDIMED questionnaire
Changes in eating habits will be estimated by 24h recall and PREDIMED questionnaire which is a questionnaire to assess the adherence to the Mediterranean diet, 0 being the minimum total score and 14 the maximum total score. Higher values represent a higher adherence to the Mediterranean diet.
Measured: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in the level of physical exercise estimated by the International Physical Activity Questionnaire (IPAQ)
Changes in the level of physical exercise will be estimated by the International Physical Activity Questionnaire (IPAQ) which is a questionnaire to assess the level of physical activity. This questionnaire obtains the subject's Metabolic Equivalent of Task (MET) of the last week adding up the MET values of the different types of physical activities the subject has done in the last week. Higher values represent a higher level of physical activity.
Measured: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in emotional eating estimated by the Dutch Eating Behaviour Questionnaire (DEBQ)
Changes in emotional eating will be estimated by the Dutch Eating Behaviour Questionnaire (DEBQ) which is a questionnaire that comprises three scales that measure emotional, external and restrained eating; being 0 the minimum score and 52 the maximum score of the emotional eating scale, 0 the minimum score and 40 the maximum score of the external eating scale and 0 the minimum score and 40 the maximum score of the restrained eating scale. Higher values represent a higher emotional, external or restrained eating.
Measured: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in the quality of life estimated by the Impact of Weight in the Quality of Life-Lite Questionnaire (IWQOL-Lite)
Changes in the quality of life will be estimated by the Impact of Weight in the Quality of Life-Lite Questionnaire (IWQOL-Lite) which is a questionnaire to assess quality of life in obesity. It comprises five subscales that measure weight-related concerns across five domains: Physical Function, Self-Esteem, Sexual Life, Public Distress and Work. The minimum score of the total punctuation is 31 and the maximum punctuation is 155; the minimum score of the Physical Function scale is 11 and the maximum score is 55; the minimum score of the Self-Esteem scale is 7 and the maximum score is 35; the minimum score of the Sexual Life scale is 4 and the maximum score is 20; the minimum score of the Public Distress scale is 5 and the maximum score is 25 and the minimum score of the Work scale is 4 and the maximum is 20. Higher values represent a higher impact of weight in the quality of life of the individual, in the total score and in each of the domains assessed.
Measured: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in weight self-stigma estimated by the Weight Self-Stigma Questionnaire (WSSQ)
Changes in weight self-stigma will be estimated by the Weight Self-Stigma Questionnaire (WSSQ) which is a questionnaire to assess weight-related self-stigma that comprises two subscales apart from the total punctuation: self-devaluation and fear of enacted stigma. The minimum score of the total punctuation is 0 and the maximum is 72; the minimum score of the Self-Devaluation subscale is 0 and the maximum is 36; the minimum score of the Fear of Enacted-Stigma subscale is 0 and the maximum is 36. Higher values represent a higher weight-related self-stigma, in the total score and in each of the subscales.
Measured: Pretreatment-Posttreatment (5 months)-7 months follow-up
Secondary outcomes (10)
Changes in fat percentage measured by Bio-electrical Impedance Analysis (TANITA)
Changes in fat percentage will be measured by Bio-electrical Impedance Analysis (TANITA).
Measured: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in muscle mass percentage measured by Bio-electrical Impedance Analysis (TANITA)
Changes in muscle mass percentage will be measured by Bio-electrical Impedance Analysis (TANITA).
Measured: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in insulin sensitivity measured by homeostasis model assessment (HOMA)
Changes in insulin sensitivity will be measured by homeostasis model assessment (HOMA).
Measured: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in serum lipid profile
Changes in total, LDL- and HDL-cholesterol will be measured.
Measured: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in glucose profile measured by a spectrophotometry
Changes in the glucose level will be measured by a spectrophotometry.
Measured: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in waist circumference measured by an inelastic tape (Holtain)
Changes in waist circumference will be measured by an inelastic tape (Holtain).
Measured: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in blood pressure measured by a sphygmomanometer
Changes in blood pressure will be measured by a sphygmomanometer.
Measured: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in general health estimated by the General Health Questionnaire-28 (GHQ-28)
Changes in general health will be estimated by the General Health Questionnaire-28 (GHQ-28), which is a questionnaire to assess the current general health state. Apart from the total punctuation, it comprises four subscales: Somatic Symptoms, Anxiety/Insomnia, Social Dysfunction and Severe Depression. There are two methods to score the GHQ-28. It can be scored from 0 to 3 for each response with a total possible score on the ranging from 0 to 84. Using this method, a total score of 23/24 is the threshold for the presence of distress. Alternatively, the GHQ-28 can be scored with a binary method where "Not at all", and "No more than usual" score 0, and "Rather more than usual" and "Much more than usual" score 1. Using this method, any score above 4 indicates the presence of distress or 'caseness'.
Measured: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in eating attitudes estimated by the Eating Attitudes Test-12 (EAT-12)
Changes in eating attitudes will be estimated by the Eating Attitudes Test-12 (EAT-12), which is a screening questionnaire to capture undifferentiated eating disorders. Apart from the total punctuation, it comprises three scales: Dieting, Bulimia and food preoccupation and Oral control. The minimum score of the total punctuation is 0 and the maximum score is 36; the minimum score of the Dieting scale is 0 and the maximum score is 12; the minimum score of the Bulimia and food preoccupation is 0 and the maximum score is 12 and the minimum score of the Oral control scale is 0 and the maximum score is 12. Higher values represent further eating problems.
Measured: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in body image's self-perception estimated by the Figure Rating Scale (FRS)
Changes in body image's self-perception will be estimated by the Figure Rating Scale (FRS), which determines body dissatisfaction in women and men. It consists of nine figures of increasing size with accompanying numerical ratings from 1 to 9. Subjects have to choose two figures that represent how they think they look like and their ideal figure. The higher the discrepancy between these figures, the more subjective body dissatisfaction the individual will have.
Measured: Pretreatment-Posttreatment (5 months)-7 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start3 Nov 2018
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
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 Overweight and ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Basque Country (UPV/EHU)
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain, Basque Health Service
- Responsible party
- Principal investigator, Edurne Maiz Aldalur, University of the Basque Country (UPV/EHU)
- Investigators
- Edurne Maiz Aldalur, PhD, Principal investigator, Assistant teacher in the Department of Personality, Assessment and Psychological Treatments of the Faculty of Psychology of the Basque Country University (EHU/UPV)Enrique Echeburúa Odriozola, Professor, Principal investigator, Professor in Clinical Psychology in the Department of Personality, Assessment and Psychological Treatments of the Faculty of Psychology of the Basque Country University (EHU/UPV)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718728
- Sponsor's protocol ID
- PSI2017-88583-R
- Acronym
- Mind&Life
- Status last verified
- Feb 2023
- First submitted
- 19 Oct 2018
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Iturbe I, Pereda-Pereda E, Echeburua E, Maiz E. The Effectiveness of an Acceptance and Commitment Therapy and Mindfulness Group Intervention for Enhancing the Psychological and Physical Well-Being of Adults with Overweight or Obesity Seeking Treatment: The Mind&Life Randomized Control Trial Study Protocol. Int J Environ Res Public Health. 2021 Apr 21;18(9):4396. doi: 10.3390/ijerph18094396.
PubMed 33919059
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Group Intervention Program Based on Acceptance and Mindfulness on the Physical and Emotional Well-being of Overweight and Obese Individuals; Mind&Life Project
- ClinicalTrials.gov ID
- NCT03718728
- Acronym / sponsor ID
- Mind&Life / PSI2017-88583-R
- Conditions
- Overweight and Obesity
- Keywords
- Overweight, Obesity, Adults, Mindfulness, Acceptance, Emotional eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University of the Basque Country (UPV/EHU)University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain, Basque Health Service
- Study start
- 3 Nov 2018 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 24 Oct 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.
The objective of the present study is to evaluate the effect of a 20-week group intervention program based on acceptance and mindfulness in emotional eating, weight loss, physiological parameters and the level of physical exercise, as well as in the quality-of-life and weight self-stigma of overweight and obese people on the short- and medium-term.
Design, participants, and method: A randomized clinical trial comprising a total of 110 overweight or obese (BMI ≥ 25) participants that are receiving medical treatment at Primary Care Centers, 20-65 years, will be included and randomly assigned to standard program (N=55) or standard + intervention program (N=55). The standard program group will receive the treatment as usual (TAU) that comprises 5 sessions (on a monthly basis) that will include a personalized diet and physical exercise recommendations, while the standard + intervention program group will receive the same TAU plus the acceptance and mindfulness-based group intervention program.
At baseline prior to randomization, after the intervention, and seven months after the program has finished anthropometric and body composition data, biochemical data in blood, waist circumference, blood pressure, eating habits, level of physical exercise, general health, emotional eating, quality-of-life, weight self-stigma, experiential avoidance, self-compassion level and mindfulness abilities will be evaluated.
It is hypothesized that the integrated treatment of obesity implementing a group intervention program based on acceptance and mindfulness could help to reduce the emotional eating, enhance weight loss, improve physiological parameters, increase the level of physical exercise, improve the quality of life and reduce the weight self-stigma of overweight and obese individuals.
Detailed description
The standard program group will receive the TAU that comprises 5 monthly sessions of 30 minutes that will include a personalized diet and physical exercise recommendations.
The standard + intervention program group will receive the same TAU plus the acceptance and mindfulness-based group intervention program. The first ten sessions will be held weekly and the last five, biweekly. The duration of sessions will be 2 hours and will include a mindfulness practice, the session content (i.e. control as the problem, willingness, etc.), followed by a mindful eating practice to train the ability to pay attention to food and eating physical sensations. Finally, the session content will be briefly revised and practices for the week will be established.
The following measurements will be evaluated at baseline prior to randomization, after the intervention, and seven months after the program has finished: anthropometric and body composition data, that is, weight and fat and muscle mass percentage (Bio-electrical Impedance Analysis, TANITA) and height (SECA 227); biochemical data in blood; waist circumference (Holtain inelastic tape); blood pressure; eating habits (24h recall and PREDIMED); level of physical exercise (IPAQ); general health (GHQ-28); emotional eating (DEBQ); quality-of-life (IWQOL-Lite); weight self-stigma (WSSQ); experiential avoidance (AAQ-II); self-compassion level (SCS) and mindfulness abilities (FFMQ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard group | Active comparator | Behavioral: StandardA personalized diet and physical exercise recommendations. |
| Mind&Life (standard + intervention) group | Experimental | Behavioral: Mind&Life, Behavioral: StandardA personalized diet and physical exercise recommendations plus the acceptance and mindfulness-based group intervention program. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults with overweight or obesity (estimated by BMI ≥ 25 and classified by the International Obesity Task Force, IOTF);
- Have asked for enrollment in nutritional treatment for weight loss in primary care units from Donostia-San Sebastian;
- Willingness to participate in the study.
Key exclusion criteria (3 listed)
- Diagnosed with eating disorders; such as, Binge Eating Disorder, Anorexia or Bulimia;
- Diagnosed with any psychiatric disorder or intellectual disability that doesn't allow to carry out the intervention;
- Not to know sufficiently the language the intervention is carried out.
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 |
|---|---|---|
| Mind&LifeAcceptance and mindfulness-based group intervention program. | Behavioural | Mind&Life (standard + intervention) group |
| StandardPersonalized diet and physical exercise recommendations. | Behavioural | Mind&Life (standard + intervention) group, Standard group |
Primary outcome
Changes in Body Mass Index (BMI) measured by Bio-electrical Impedance Analysis (TANITA)
Time frame: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in Body Mass Index (BMI - kg/m2) will be measured by Bio-electrical Impedance Analysis (TANITA).
Changes in eating habits estimated by 24h recall and PREDIMED questionnaire
Time frame: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in eating habits will be estimated by 24h recall and PREDIMED questionnaire which is a questionnaire to assess the adherence to the Mediterranean diet, 0 being the minimum total score and 14 the maximum total score. Higher values represent a higher adherence to the Mediterranean diet.
Changes in the level of physical exercise estimated by the International Physical Activity Questionnaire (IPAQ)
Time frame: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in the level of physical exercise will be estimated by the International Physical Activity Questionnaire (IPAQ) which is a questionnaire to assess the level of physical activity. This questionnaire obtains the subject's Metabolic Equivalent of Task (MET) of the last week adding up the MET values of the different types of physical activities the subject has done in the last week. Higher values represent a higher level of physical activity.
Changes in emotional eating estimated by the Dutch Eating Behaviour Questionnaire (DEBQ)
Time frame: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in emotional eating will be estimated by the Dutch Eating Behaviour Questionnaire (DEBQ) which is a questionnaire that comprises three scales that measure emotional, external and restrained eating; being 0 the minimum score and 52 the maximum score of the emotional eating scale, 0 the minimum score and 40 the maximum score of the external eating scale and 0 the minimum score and 40 the maximum score of the restrained eating scale. Higher values represent a higher emotional, external or restrained eating.
Changes in the quality of life estimated by the Impact of Weight in the Quality of Life-Lite Questionnaire (IWQOL-Lite)
Time frame: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in the quality of life will be estimated by the Impact of Weight in the Quality of Life-Lite Questionnaire (IWQOL-Lite) which is a questionnaire to assess quality of life in obesity. It comprises five subscales that measure weight-related concerns across five domains: Physical Function, Self-Esteem, Sexual Life, Public Distress and Work. The minimum score of the total punctuation is 31 and the maximum punctuation is 155; the minimum score of the Physical Function scale is 11 and the maximum score is 55; the minimum score of the Self-Esteem scale is 7 and the maximum score is 35; the minimum score of the Sexual Life scale is 4 and the maximum score is 20; the minimum score of the Public Distress scale is 5 and the maximum score is 25 and the minimum score of the Work scale is 4 and the maximum is 20. Higher values represent a higher impact of weight in the quality of life of the individual, in the total score and in each of the domains assessed.
Changes in weight self-stigma estimated by the Weight Self-Stigma Questionnaire (WSSQ)
Time frame: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in weight self-stigma will be estimated by the Weight Self-Stigma Questionnaire (WSSQ) which is a questionnaire to assess weight-related self-stigma that comprises two subscales apart from the total punctuation: self-devaluation and fear of enacted stigma. The minimum score of the total punctuation is 0 and the maximum is 72; the minimum score of the Self-Devaluation subscale is 0 and the maximum is 36; the minimum score of the Fear of Enacted-Stigma subscale is 0 and the maximum is 36. Higher values represent a higher weight-related self-stigma, in the total score and in each of the subscales.
10 secondary outcomes
Changes in fat percentage measured by Bio-electrical Impedance Analysis (TANITA)
Time frame: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in muscle mass percentage measured by Bio-electrical Impedance Analysis (TANITA)
Time frame: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in insulin sensitivity measured by homeostasis model assessment (HOMA)
Time frame: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in serum lipid profile
Time frame: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in glucose profile measured by a spectrophotometry
Time frame: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in waist circumference measured by an inelastic tape (Holtain)
Time frame: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in blood pressure measured by a sphygmomanometer
Time frame: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in general health estimated by the General Health Questionnaire-28 (GHQ-28)
Time frame: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in eating attitudes estimated by the Eating Attitudes Test-12 (EAT-12)
Time frame: Pretreatment-Posttreatment (5 months)-7 months follow-up
Changes in body image's self-perception estimated by the Figure Rating Scale (FRS)
Time frame: Pretreatment-Posttreatment (5 months)-7 months follow-up
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 9 Feb 2023.
- Derived from this study: PubMed 33919059Iturbe I, Pereda-Pereda E, Echeburua E, Maiz E. The Effectiveness of an Acceptance and Commitment Therapy and Mindfulness Group Intervention for Enhancing the Psychological and Physical Well-Being of Adults with Overweight or Obesity Seeking Treatment: The Mind&Life Randomized Control Trial Study Protocol. Int J Environ Res Public Health. 2021 Apr 21;18(9):4396. doi: 10.3390/ijerph18094396.
- Individual participant dataSharing planned: No
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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.
Edurne Maiz Aldalur, PhD principal investigator
Assistant teacher in the Department of Personality, Assessment and Psychological Treatments of the Faculty of Psychology of the Basque Country University (EHU/UPV)
Enrique Echeburúa Odriozola, Professor principal investigator
Professor in Clinical Psychology in the Department of Personality, Assessment and Psychological Treatments of the Faculty of Psychology of the Basque Country University (EHU/UPV)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind&Life and Standard in people with Overweight and Obesity, run by University of the Basque Country (UPV/EHU) 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 3 inclusion and 3 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 9 Feb 2023. 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?
Changes in Body Mass Index (BMI) measured by Bio-electrical Impedance Analysis (TANITA) (time frame: Pretreatment-Posttreatment (5 months)-7 months follow-up). The study lists 6 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 NCT03718728, 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 9 Feb 2023.