ObesityNCT05328791
Effectiveness of a Mindfulness Based Diet Program on Weight Loss
A study testing Dietary and mindfulness intervention in people with Obesity and Weight Loss, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Meditation interventions, including mindfulness-based approaches, can be effective in reducing psychological stress . Mindfulness meditation, which cultivates awareness of present-moment experience with a nonjudging attitude, is theorized to promote adaptive self-regulation,which is thought to be key to maintaining… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- Dietary and mindfulness intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2022to 20 Jul 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 20-65
- Being obese (BMI≥30 kg/m2)
- Volunteering to participate in research
Who cannot join
- Being pregnant/lactating
- Having a psychological problem
- Being on a followed diet program
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ümüş Özbey Yücel
Ankara, Select An Option…, 06000
About this study
Official title: Effectiveness of a Mindfulness Based Diet Program Given to Obese Individuals on Body Weight and Eating Behaviours
Meditation interventions, including mindfulness-based approaches, can be effective in reducing psychological stress . Mindfulness meditation, which cultivates awareness of present-moment experience with a nonjudging attitude, is theorized to promote adaptive self-regulation,which is thought to be key to maintaining long-term eating habits and appetite regulation.In the light of this information, in this study, it is aimed to observe the effect of mindfulness approach on body weight and eating behaviours.
Read the detailed description
The use of minfulness based programs for body weight control and stress management is increasing. One of the main reasons for this situation is that individuals care more about the diet and body weidght as a result of the increase in health concerns and stress. In addition, such cognitive support programs in the diet process provide a more comfortable and stress-free continuation of the diet. Based on the above-mentioned information; in this study, it is aimed to determine the effect of mindfulness based diet intervention on weight loss and eating behaviuors.
Individuals who meet the research criteria will randomize according to their file numbers (with the ramdomizer program) and divide into 2 groups: mindfulness group (15) and control group . Food consumption records, anthropometric measurements and eating behaviours scale of all individuals will record at the beginning and end of the study. In order to prevent interaction between individuals, all diet programs will prepare at different times and individually.
- Conditions
- Obesity, Weight Loss
- Being tested
- Dietary and mindfulness intervention
- Keywords
- Obesity, Weight loss, Mindfulness
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary and mindfulness interventionBehavioural
Dietary intervention: Preparation and follow-up of diet program
Mindfulness intervention: Implementation of cognitive stress reduction program
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness+Diet intervention | Experimental | Diet and mindfulness intervention Receives: Behavioral: Dietary and mindfulness intervention |
| Diet intervention | Experimental | Diet intervention Receives: Behavioral: Dietary and mindfulness intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight chance
BMI (kilogram/ metre2 (kg/m2))
Measured: At the end of the 2 months
Secondary outcomes (1)
Three factor eating questionnaire (TFEQ) scale score change
The score ranges from 0 to 100 points, with an increased score reflecting the eating disorder level
Measured: At the end of the 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start15 May 2022
- Primary completion5 Jun 2024
- Study completion20 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- Amasya University
- Responsible party
- Principal investigator, ümüş özbey yücel, Ankara University
- Investigators
- ümüş Ö yücel, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328791
- Sponsor's protocol ID
- AnkaraUniv2
- Status last verified
- Jul 2024
- First submitted
- 7 Apr 2022
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Mindfulness Based Diet Program Given to Obese Individuals on Body Weight and Eating Behaviours
- ClinicalTrials.gov ID
- NCT05328791
- Acronym / sponsor ID
- AnkaraUniv2
- Conditions
- Obesity, Weight Loss
- Keywords
- Obesity, Weight loss, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- Amasya University
- Study start
- 15 May 2022 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 14 Apr 2022 (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.
Meditation interventions, including mindfulness-based approaches, can be effective in reducing psychological stress . Mindfulness meditation, which cultivates awareness of present-moment experience with a nonjudging attitude, is theorized to promote adaptive self-regulation,which is thought to be key to maintaining long-term eating habits and appetite regulation.In the light of this information, in this study, it is aimed to observe the effect of mindfulness approach on body weight and eating behaviours.
Detailed description
The use of minfulness based programs for body weight control and stress management is increasing. One of the main reasons for this situation is that individuals care more about the diet and body weidght as a result of the increase in health concerns and stress. In addition, such cognitive support programs in the diet process provide a more comfortable and stress-free continuation of the diet. Based on the above-mentioned information; in this study, it is aimed to determine the effect of mindfulness based diet intervention on weight loss and eating behaviuors.
Individuals who meet the research criteria will randomize according to their file numbers (with the ramdomizer program) and divide into 2 groups: mindfulness group (15) and control group . Food consumption records, anthropometric measurements and eating behaviours scale of all individuals will record at the beginning and end of the study. In order to prevent interaction between individuals, all diet programs will prepare at different times and individually.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness+Diet intervention | Experimental | Behavioral: Dietary and mindfulness interventionDiet and mindfulness intervention |
| Diet intervention | Experimental | Behavioral: Dietary and mindfulness interventionDiet intervention |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being between the ages of 20-65
- Being obese (BMI≥30 kg/m2)
- Volunteering to participate in research
Key exclusion criteria (3 listed)
- Being pregnant/lactating
- Having a psychological problem
- Being on a followed diet program
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 |
|---|---|---|
| Dietary and mindfulness interventionDietary intervention: Preparation and follow-up of diet program Mindfulness intervention: Implementation of cognitive stress reduction program | Behavioural | Diet intervention, Mindfulness+Diet intervention |
Primary outcome
Weight chance
Time frame: At the end of the 2 months
BMI (kilogram/ metre2 (kg/m2))
1 secondary outcome
Three factor eating questionnaire (TFEQ) scale score change
Time frame: At the end of the 2 months
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 23 Jul 2024.
- 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.
ümüş Ö yücel principal investigator
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary and mindfulness intervention in people with Obesity and Weight Loss, run by Ankara University at 1 site in Turkey (Türkiye).
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 23 Jul 2024. 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 Turkey (Türkiye). 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?
Weight chance (time frame: At the end of the 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2024.