Mindful Eating and Current Glycemic Control in Patients With Type 2 Diabetes

NCT ID: NCT06229847

Last Updated: 2024-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

448 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2019-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this observational study is to learn about the association of the level of mindful eating with the current glycemic control in patients with type 2 diabetes. The researchers will compare different glycemic control levels with the participants mindfulness while eating. And secondly, the researchers will compare the levels of eating awareness of those with and without obesity.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In type 2 diabetes, life style adaptations, mainly healthy eating, weight loss or control and exercise constitutes the foundation of type 2 diabetes management. In addition to regulating blood sugar levels, lifestyle modifications play a significant role in controlling risk factors such as hypertension and hyperlipidemia, delaying/preventing complications from developing, and even promoting diabetes regression. It is essential not only to focus on healthy food choices in dietary therapy but also to ensure patients achieve weight loss. Another crucial point is maintaining the continuity of these lifestyle changes.

It is reported that it is quite challenging for patients to make lifestyle changes, adapt to the offered treatments, and furthermore, sustain this as a way of life. Adherence to these dietary changes is crucial for long-term success in managing diabetes and achieving weight loss goals.

In a cross-sectional study conducted by Fanning and colleagues with 148 type 2 diabetic patients, it was found that "conscious eating" is associated with better diet adherence. In a review by Dunn et al., the available data strongly support the necessity of "conscious eating" as part of weight management programs. An American Heart Association statement highlights strong evidence that irregular eating patterns can make it difficult to maintain a healthy cardiometabolic profile, and emphasizes that conscious attention to mealtime and frequency can contribute to a healthier lifestyle and better management of cardiometabolic risk factors.

In this study, the aim was to investigate the degree of eating mindfulness of patients with type 2 diabetes, and compare it between patients who had good glycemic control and patients with poorly controlled glycemic.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* given consent to the study
* having applied to Diabetes Outpatient Clinic for diabetes management
* having diagnosed with type 2 diabetes for at least 6 months
* having the mental competence to answer the questions in the questionnaire

Exclusion Criteria

* Inconclusive diagnosis of type 2 diabetes
* having not received or not using any treatment for diabetes
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Goztepe Prof Dr Suleyman Yalcın City Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ayse N Erbakan

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ayşe N Erbakan, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul Medeniyet University Goztepe Prof Dr Suleyman Yalcın City Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul Medeniyet University Goztepe Research and TRaining Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29802533 (View on PubMed)

Dunn C, Haubenreiser M, Johnson M, Nordby K, Aggarwal S, Myer S, Thomas C. Mindfulness Approaches and Weight Loss, Weight Maintenance, and Weight Regain. Curr Obes Rep. 2018 Mar;7(1):37-49. doi: 10.1007/s13679-018-0299-6.

Reference Type BACKGROUND
PMID: 29446036 (View on PubMed)

St-Onge MP, Ard J, Baskin ML, Chiuve SE, Johnson HM, Kris-Etherton P, Varady K; American Heart Association Obesity Committee of the Council on Lifestyle and Cardiometabolic Health; Council on Cardiovascular Disease in the Young; Council on Clinical Cardiology; and Stroke Council. Meal Timing and Frequency: Implications for Cardiovascular Disease Prevention: A Scientific Statement From the American Heart Association. Circulation. 2017 Feb 28;135(9):e96-e121. doi: 10.1161/CIR.0000000000000476. Epub 2017 Jan 30.

Reference Type BACKGROUND
PMID: 28137935 (View on PubMed)

Mason AE, Saslow L, Moran PJ, Kim S, Wali PK, Abousleiman H, Hartman A, Richler R, Schleicher S, Hartogensis W, Epel ES, Hecht F. Examining the Effects of Mindful Eating Training on Adherence to a Carbohydrate-Restricted Diet in Patients With Type 2 Diabetes (the DELISH Study): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Feb 20;8(2):e11002. doi: 10.2196/11002.

Reference Type BACKGROUND
PMID: 30545813 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Mindful Eating-DM

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Decreasing Stress in Diabetes
NCT04016415 COMPLETED NA